Senior Director, Quality Excellence (Systems & Technology)

<p><strong>Location:  </strong><span data-teams="true">This position may be performed remotely, but requires the flexibility and willingness to travel as needed.</span></p> <p><strong>The Opportunity</strong></p> <p><span data-contrast="none">The Senior Director of Quality Excellence (Systems & Technology) is a strategic quality leader responsible for shaping, executing, and continuously advancing the enterprise Quality Management System (QMS) and Quality systems operating model across Praxis Precision Medicines. This individual provides vision and direction for all Quality Systems functions including Veeva QMS governance, document control, GxP training administration, validation, and inspection readiness and leads supplier oversight for Quality Systems and GxP computerized system providers, including audit program execution ensuring a compliant, efficient, and scalable quality infrastructure that supports the company’s global clinical, manufacturing, and commercial operations.</span><span data-ccp-props="{"335559739":0}"> </span></p> <p><span data-contrast="none">The Senior Director serves as the organization’s subject matter expert on GxP system compliance, regulatory readiness, and quality systems excellence. This role is accountable for the strategy, oversight, and continuous improvement of Praxis’s QMS and validation programs, ensuring all GxP systems including those supporting clinical data (EDC, eCOA/ePRO/eDiary), manufacturing and supply chain (serialization, ERP, LIMS), and supporting quality systems are fit for intended use and maintained in a controlled state using risk-based lifecycle practices aligned with current industry expectations (e.g., CSA concepts and GAMP 5).</span><span data-ccp-props="{"335559739":0}"> </span></p> <p><span data-contrast="none">Partnering closely with senior leadership across Quality, Clinical, Technical Operations, and IT, the Senior Director drives a culture of proactive quality, operational discipline, and continuous improvement to ensure the highest standards of regulatory compliance and inspection readiness across the enterprise from clinical development through commercial operations.</span><span data-ccp-props="{"335559739":0}"> </span></p> <p> </p> <p><strong>Primary Responsibilities</strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Lead the strategy, governance, and continuous improvement of Praxis’s enterprise QMS to ensure compliance with global </span><span data-ccp-parastyle="Normal (Web)">GxP</span><span data-ccp-parastyle="Normal (Web)"> regulations and alignment with corporate and regulatory </span><span data-ccp-parastyle="Normal (Web)">objectives</span><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Serve as the process owner for QMS elements including document control, deviation/CAPA management, change control, training, and </span><span data-ccp-parastyle="Normal (Web)">risk management, ensuring process effectiveness and harmonization across all </span><span data-ccp-parastyle="Normal (Web)">GxP</span><span data-ccp-parastyle="Normal (Web)"> functions.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Provide leadership and oversight for computerized </span><span data-ccp-parastyle="Normal (Web)">lifecycle controls (CSV/CSA) for </span><span data-ccp-parastyle="Normal (Web)">GxP</span><span data-ccp-parastyle="Normal (Web)"> computerized systems, ensuring systems supporting clinical, manufacturing, and commercial operations are </span><span data-ccp-parastyle="Normal (Web)">maintained</span><span data-ccp-parastyle="Normal (Web)"> in a compliant state including internally developed applications and externally hosted/vendor-managed SaaS platforms.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Partner with IT, Clinical Operations, Technical Operations, and Commercial teams to </span><span data-ccp-parastyle="Normal (Web)">establish</span><span data-ccp-parastyle="Normal (Web)"> </span><span data-ccp-parastyle="Normal (Web)">-based lifecycle standards that ensure system suitability, data integrity, and consistent execution (requirements, testing, release/change control, periodic review, and decommissioning/archiving).</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Evaluate and qualify vendors, CROs, and CMOs supporting Praxis systems, providing QA oversight </span><span data-ccp-parastyle="Normal (Web)">supplier documentation and oversight activities, and lead supplier oversight for </span><span data-ccp-parastyle="Normal (Web)">GxP</span><span data-ccp-parastyle="Normal (Web)"> computerized </span><span data-ccp-parastyle="Normal (Web)">systems (quality agreements/oversight plans, risk-based audits, performance monitoring, and CAPA follow-up as applicable).</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Maintain oversight of electronic systems, including Veeva QMS, ensuring </span><span data-ccp-parastyle="Normal (Web)">appropriate configuration</span><span data-ccp-parastyle="Normal (Web)">, document hierarchy, and workflow management.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Lead the global </span><span data-ccp-parastyle="Normal (Web)">GxP</span><span data-ccp-parastyle="Normal (Web)"> </span><span data-ccp-parastyle="Normal (Web)">training administration</span><span data-ccp-parastyle="Normal (Web)"> program, including development of curricula, compliance tracking, and training effectiveness measurement.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Establish and oversee QMS governance mechanisms, including Quality Management Reviews, issue escalation processes, and risk management frameworks.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Ensure ongoing </span><span data-ccp-parastyle="Normal (Web)">inspection</span><span data-ccp-parastyle="Normal (Web)"> readiness across all </span><span data-ccp-parastyle="Normal (Web)">GxP</span><span data-ccp-parastyle="Normal (Web)"> functions, </span><span data-ccp-parastyle="Normal (Web)">maintaining</span><span data-ccp-parastyle="Normal (Web)"> compliant systems, documentation, and records suitable for regulatory and partner audits</span><span data-ccp-parastyle="Normal (Web)"> and </span><span data-ccp-parastyle="Normal (Web)">lead backroom support and response coordination as needed</span><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Monitor evolving regulatory expectations, guidance, and industry trends; implement </span><span data-ccp-parastyle="Normal (Web)">timely</span><span data-ccp-parastyle="Normal (Web)"> updates to processes, procedures, and </span><span data-ccp-parastyle="Normal (Web)">computerized systems lifecycle practices</span><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Define, monitor, and report key QMS and validation metrics to assess performance, </span><span data-ccp-parastyle="Normal (Web)">identify</span><span data-ccp-parastyle="Normal (Web)"> trends, and drive data-driven improvements.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Lead, mentor, and develop a high-performing team of QMS and validation professionals, fostering accountability, collaboration, and continuous learning.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Represent Quality leadership in enterprise governance and initiatives, </span><span data-ccp-parastyle="Normal (Web)">providing</span><span data-ccp-parastyle="Normal (Web)"> expert guidance on </span><span data-ccp-parastyle="Normal (Web)">GxP</span><span data-ccp-parastyle="Normal (Web)"> system compliance, quality risk management, and digital transformation.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Drive sustained inspection readiness and execution support, including post-inspection commitments and </span><span data-ccp-parastyle="Normal (Web)">CAPA to</span><span data-ccp-parastyle="Normal (Web)"> closure.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <p> </p> <p><strong>Qualifications and Key Success Factors</strong></p> <p> </p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="15" data-aria-level="1"><span data-contrast="auto">BS/BA in a relevant scientific discipline, or ASQ or equivalent professional certification; equivalent experience considered.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="16" data-aria-level="1"><span data-contrast="auto">Minimum 15 years of progressive experience in the pharmaceutical or biotechnology industry, with direct Quality Systems and Quality Assurance experience; at least five years in a leadership role.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="17" data-aria-level="1"><span data-contrast="auto">Demonstrated expertise in developing, implementing, and managing enterprise QMS’ across clinical, manufacturing, and commercial functions.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="18" data-aria-level="1"><span data-contrast="auto">Proven success governing QMS processes such as document control, training, deviation/CAPA, change management, and risk management, ensuring operational consistency and compliance.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="19" data-aria-level="1"><span data-contrast="auto">Hands-on experience validating GxP and enterprise systems, ensuring compliance with lifecycle management, change control, and data integrity principles including experience with internally developed systems and SaaS/vendor-managed platforms.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="20" data-aria-level="1"><span data-contrast="auto">Demonstrated leadership experience supporting both clinical-stage and commercial operations environments (ability to scale systems and expectations across the product lifecycle).</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="21" data-aria-level="1"><span data-contrast="auto">Documented history supporting regulatory inspections and partner audits, including inspection readiness leadership, backroom support, response coordination, and CAPA execution to closure.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="22" data-aria-level="1"><span data-contrast="auto">Strong working knowledge of FDA, EMA, and global GxP regulations (21 CFR Parts 11, 210, 211, 312) and application of GAMP 5 guidance and familiarity with current risk-based validation approaches (CSA concepts).</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="23" data-aria-level="1"><span data-contrast="auto">Demonstrated ability to analyze and optimize quality processes, establish meaningful performance metrics, and lead cross-functional governance forums.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="24" data-aria-level="1"><span data-contrast="auto">Strategic, solutions-driven quality leader with excellent collaboration, communication, and influencing skills.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="25" data-aria-level="1"><span data-contrast="auto">Proficient in Veeva Vault applications (QualityDocs, QMS, Clinical, RIM, Training), as well as DocuSign and SharePoint. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <p>The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.</p> <p> </p> <p><strong>Compensation & Benefits</strong></p> <p><span data-teams="true">At Praxis, we believe that taking care of our people (and <em>their</em> people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! </span></p> <p>To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Annualized Base Salary</div><div class="pay-range"><span>$230,000</span><span class="divider">—</span><span>$250,000 USD</span></div></div></div><div class="content-conclusion"><p><strong>Company Overview</strong> </p> <p>Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.  At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.  Our core Values of <strong>Trust</strong>, <strong>Ownership</strong>, <strong>Curiosity</strong> and <strong>Results</strong> are foundational to every aspect of our business and are exemplified by each and every one of our team members.<br><br><strong>Diversity, Equity & Inclusion</strong><br>Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE<sup>®</sup> to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.<br><br><strong>Attention: Job Scam Alert</strong><br>Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to <a href="mailto:careers@praxismedicines.com">careers@praxismedicines.com</a>.<br><br><strong>Praxis does not accept unsolicited submissions from recruitment agencies for open positions. </strong>We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.</p></div>