Associate Director, Quality Operations - Commercial & Stability, CMC

<p><strong><span data-contrast="none">Location:  </span></strong><span data-contrast="none"> This position may be performed remotely with travel to the Boston area as needed.  Requires a</span><span data-contrast="none"><span data-ccp-parastyle="paragraph">bility to travel domestically and internationally to meet program needs (estimated 15-20%). </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></p> <p> </p> <p><strong><span data-contrast="none">Position Summary</span></strong><span data-ccp-props="{"335559739":60}"> </span></p> <p><span data-contrast="none">The Associate Director, Quality Operations – Commercial & Stability, CMC will lead the development and execution of quality oversight strategies across commercial and clinical supply chains, with a focus on stability programs. This strategic role is accountable for ensuring GMP compliance in support of global product distribution, driving operational excellence, and building strong cross-functional partnerships across Quality, Manufacturing, Regulatory Affairs, and external partners. The ideal candidate brings a sharp strategic lens, operational rigor, and a strong quality mindset.</span><span data-ccp-props="{"335559739":60}"> </span></p> <p><strong><span data-contrast="none">Primary Responsibilities</span></strong><span data-ccp-props="{"335559739":60}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph" data-ccp-parastyle-defn="{"ObjectId":"aaed607e-c2a3-5841-9fb4-41037bfa0faf|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Times New Roman",469777842,"Times New Roman",469777843,"Times New Roman",469777844,"Times New Roman",201341986,"1",469769226,"Times New Roman",268442635,"24",469775450,"paragraph",201340122,"2",134233614,"true",469778129,"paragraph",335572020,"1",335559740,"240",201341983,"0",134233118,"true",134233117,"true",469778324,"Normal"]}">Provide strategic leadership for commercial and clinical stability programs, ensuring global regulatory compliance and proactive risk management.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Oversee quality operations related to 3PL contract service providers (CSPs), ensuring robust quality systems and oversight for distribution and release activities.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Lead the development, review, and approval of key product and process documents including regulatory submissions, stability protocols, mock recalls, and annual product reviews (APR/PQR).</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Own quality review and approval of change controls, deviations, investigations, temperature excursions, CAPA, and Product Quality Complaints.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Guide </span><span data-ccp-parastyle="paragraph">field</span><span data-ccp-parastyle="paragraph"> alert reporting (FAR) strategies, including trending analysis and early detection systems.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Serve as the quality lead for commercial readiness initiatives, regulatory inspections, and pre-approval inspection activities.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Collaborate closely with Regulatory Affairs, Manufacturing, and external partners to drive continuous improvement, </span><span data-ccp-parastyle="paragraph">maintain</span><span data-ccp-parastyle="paragraph"> </span><span data-ccp-parastyle="paragraph">inspection</span><span data-ccp-parastyle="paragraph"> readiness, and resolve issues with urgency and clarity.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none">Represent Quality in cross-functional strategic discussions and governance forums.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li><span data-contrast="none">Ensure cohesive collaboration across CSPs for timely review of GMP records </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li><span data-contrast="none">Support pre-approval inspection and commercial readiness activities, internal and external audits </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><strong><span data-contrast="none">Qualifications and Key Success Factors</span></strong><span data-ccp-props="{"335559739":60}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">BA or BS degree in Chemistry or related field</span><span data-ccp-parastyle="paragraph">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">10</span><span data-ccp-parastyle="paragraph"> </span><span data-ccp-parastyle="paragraph">+ years</span><span data-ccp-parastyle="paragraph"> </span><span data-ccp-parastyle="paragraph">in a GMP setting working with clinical and commercial products</span><span data-ccp-parastyle="paragraph">.</span><span data-ccp-parastyle="paragraph"> </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Experience managing stability programs.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Direct experience with recall, APR</span><span data-ccp-parastyle="paragraph">, FAR</span><span data-ccp-parastyle="paragraph"> management.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Firsthand</span><span data-ccp-parastyle="paragraph"> experience with interpreting and </span><span data-ccp-parastyle="paragraph">implementing of</span><span data-ccp-parastyle="paragraph"> regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA). </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Proven ability to </span><span data-ccp-parastyle="paragraph">operate</span><span data-ccp-parastyle="paragraph"> independently, influence cross-functionally, and make clear, </span><span data-ccp-parastyle="paragraph">timely</span><span data-ccp-parastyle="paragraph"> decisions.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Proven </span><span data-ccp-parastyle="paragraph">track record</span><span data-ccp-parastyle="paragraph"> and experience in supporting regulatory inspections (FDA, EMA)</span><span data-ccp-parastyle="paragraph">.</span><span data-ccp-parastyle="paragraph"> </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Experience with interfacing with </span><span data-ccp-parastyle="paragraph">a QP</span><span data-ccp-parastyle="paragraph"> and CSPs</span><span data-ccp-parastyle="paragraph">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Excellent written, </span><span data-ccp-parastyle="paragraph">organizational,</span><span data-ccp-parastyle="paragraph"> and oral communication skills. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Must thrive working in a fast-paced, innovative environment while </span><span data-ccp-parastyle="paragraph">remaining</span><span data-ccp-parastyle="paragraph"> flexible, proactive, resourceful, and efficient.  </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Experience with product monitoring, complaint handling</span><span data-ccp-parastyle="paragraph">, and issue</span><span data-ccp-parastyle="paragraph"> resolution preferred</span><span data-ccp-parastyle="paragraph">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Demonstrates </span><span data-ccp-parastyle="paragraph">a high level</span><span data-ccp-parastyle="paragraph"> of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.  </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all their forms.  </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Highly organized and detail-oriented with a passion to deliver quality results.  </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="paragraph">Ability to travel domestically and internationally to meet program needs (estimated 15-20%). </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <p> <br><strong><span data-contrast="none"><span data-ccp-parastyle="paragraph">Compensation & Benefits</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"134233279":true,"201341983":0,"335559738":120,"335559739":120,"335559740":240,"469777462":[360],"469777927":[0],"469777928":[1]}"> </span></p> <p><span data-contrast="auto">At Praxis, we believe that taking care of our people (and their 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><span data-ccp-props="{"335559738":180,"335559739":180}"> </span></p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Annualized Base Salary</div><div class="pay-range"><span>$163,000</span><span class="divider">—</span><span>$183,000 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>