Senior Director, Quality Excellence (Systems & Technology)

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

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. 

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). 

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. 

 

Primary Responsibilities

• Lead the strategy, governance, and continuous improvement of Praxis’s enterprise QMS to ensure compliance with global GxP regulations and alignment with corporate and regulatory objectives. 

• Serve as the process owner for QMS elements including document control, deviation/CAPA management, change control, training, and risk management, ensuring process effectiveness and harmonization across all GxP functions. 

• Provide leadership and oversight for computerized lifecycle controls (CSV/CSA) for GxP computerized systems, ensuring systems supporting clinical, manufacturing, and commercial operations are maintained in a compliant state including internally developed applications and externally hosted/vendor-managed SaaS platforms. 

• Partner with IT, Clinical Operations, Technical Operations, and Commercial teams to establish -based lifecycle standards that ensure system suitability, data integrity, and consistent execution (requirements, testing, release/change control, periodic review, and decommissioning/archiving). 

• Evaluate and qualify vendors, CROs, and CMOs supporting Praxis systems, providing QA oversight supplier documentation and oversight activities, and lead supplier oversight for GxP computerized systems (quality agreements/oversight plans, risk-based audits, performance monitoring, and CAPA follow-up as applicable). 

• Maintain oversight of electronic systems, including Veeva QMS, ensuring appropriate configuration, document hierarchy, and workflow management. 

• Lead the global GxP training administration program, including development of curricula, compliance tracking, and training effectiveness measurement. 

• Establish and oversee QMS governance mechanisms, including Quality Management Reviews, issue escalation processes, and risk management frameworks. 

• Ensure ongoing inspection readiness across all GxP functions, maintaining compliant systems, documentation, and records suitable for regulatory and partner audits and lead backroom support and response coordination as needed. 

• Monitor evolving regulatory expectations, guidance, and industry trends; implement timely updates to processes, procedures, and computerized systems lifecycle practices. 

• Define, monitor, and report key QMS and validation metrics to assess performance, identify trends, and drive data-driven improvements. 

• Lead, mentor, and develop a high-performing team of QMS and validation professionals, fostering accountability, collaboration, and continuous learning. 

• Represent Quality leadership in enterprise governance and initiatives, providing expert guidance on GxP system compliance, quality risk management, and digital transformation. 

• Drive sustained inspection readiness and execution support, including post-inspection commitments and CAPA to closure. 

 

Qualifications and Key Success Factors

 

• BS/BA in a relevant scientific discipline, or ASQ or equivalent professional certification; equivalent experience considered. 

• 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. 

• Demonstrated expertise in developing, implementing, and managing enterprise QMS’ across clinical, manufacturing, and commercial functions. 

• Proven success governing QMS processes such as document control, training, deviation/CAPA, change management, and risk management, ensuring operational consistency and compliance. 

• 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. 

• Demonstrated leadership experience supporting both clinical-stage and commercial operations environments (ability to scale systems and expectations across the product lifecycle). 

• Documented history supporting regulatory inspections and partner audits, including inspection readiness leadership, backroom support, response coordination, and CAPA execution to closure. 

• 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). 

• Demonstrated ability to analyze and optimize quality processes, establish meaningful performance metrics, and lead cross-functional governance forums. 

• Strategic, solutions-driven quality leader with excellent collaboration, communication, and influencing skills. 

• Proficient in Veeva Vault applications (QualityDocs, QMS, Clinical, RIM, Training), as well as DocuSign and SharePoint.  

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.

 

Compensation & Benefits

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! 

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.