Associate Director, Quality Operations - Commercial & Stability, CMC
Location: This position may be performed remotely with travel to the Boston area as needed. Requires ability to travel domestically and internationally to meet program needs (estimated 15-20%).
Position Summary
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.
Primary Responsibilities
- Provide strategic leadership for commercial and clinical stability programs, ensuring global regulatory compliance and proactive risk management.
- Oversee quality operations related to 3PL contract service providers (CSPs), ensuring robust quality systems and oversight for distribution and release activities.
- 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).
- Own quality review and approval of change controls, deviations, investigations, temperature excursions, CAPA, and Product Quality Complaints.
- Guide field alert reporting (FAR) strategies, including trending analysis and early detection systems.
- Serve as the quality lead for commercial readiness initiatives, regulatory inspections, and pre-approval inspection activities.
- Collaborate closely with Regulatory Affairs, Manufacturing, and external partners to drive continuous improvement, maintain inspection readiness, and resolve issues with urgency and clarity.
- Represent Quality in cross-functional strategic discussions and governance forums.
- Ensure cohesive collaboration across CSPs for timely review of GMP records
- Support pre-approval inspection and commercial readiness activities, internal and external audits
Qualifications and Key Success Factors
- BA or BS degree in Chemistry or related field.
- 10 + years in a GMP setting working with clinical and commercial products.
- Experience managing stability programs.
- Direct experience with recall, APR, FAR management.
- Firsthand experience with interpreting and implementing of regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA).
- Proven ability to operate independently, influence cross-functionally, and make clear, timely decisions.
- Proven track record and experience in supporting regulatory inspections (FDA, EMA).
- Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products.
- Experience with interfacing with a QP and CSPs.
- Excellent written, organizational, and oral communication skills.
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
- Experience with product monitoring, complaint handling, and issue resolution preferred.
- Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
- Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all their forms.
- Highly organized and detail-oriented with a passion to deliver quality results.
- Ability to travel domestically and internationally to meet program needs (estimated 15-20%).
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!
Company Overview
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 Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® 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.
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What We Do
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. Praxis is applying insights into the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for rare and more prevalent neurological disorders. 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. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain.
