Praxis Precision Medicines, Inc. · 19 hours ago
Associate Director, Quality Operations - Commercial & Stability, CMC
United States
Full-time
Remote
Lead/Staff, Director/Executive
$163K/yr - $183K/yr
10+ years expPraxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Associate Director, Quality Operations will lead quality oversight strategies across commercial and clinical supply chains, ensuring GMP compliance and driving operational excellence.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
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
Qualification
Required
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%)
Preferred
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
Benefits
99% of the premium paid for medical, dental, and vision plans
Company-paid life insurance
AD&D
Disability benefits
Voluntary plans to personalize your coverage
We match dollar-for-dollar up to 6% on eligible 401(k) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns
Company
Praxis Precision Medicines, Inc.
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.
51-200 employees
H1B Sponsorship
Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
2026-01-07
2026-01-07
Company data provided by crunchbase