Associate Director, Quality Operations - Commercial & Stability, CMC

Location: United States - Remote

Department: Quality

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!