Associate Director, Quality Operations - Commercial & Stability, CMC

Praxis Precision Medicines, Inc.

3d • $163,000 - $183,000 • Remote

About The Position

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.

Requirements

• 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.
• Ability to travel domestically and internationally to meet program needs (estimated 15-20%).

Nice To Haves

• 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.

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

Benefits

• 99% of the premium paid for medical, dental, and vision plans.
• company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
• dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP
• discretionary quarterly bonus
• extremely flexible wellness benefit
• generous PTO
• paid holidays and company-wide shutdowns

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees