Associate Director, Commercial Product Quality US Regional Lead, External Supply Quality

Jobgether · US

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Commercial Product Quality US Regional Lead, External Supply Quality based in the United States.

This senior leadership role is responsible for ensuring the highest standards of quality across externally manufactured commercial pharmaceutical products, with a strong focus on compliance, patient safety, and regulatory excellence. You will oversee contract manufacturing organization (CMO) quality performance across small and large molecule products throughout the US region. The role plays a critical part in safeguarding product integrity across the entire lifecycle, from post-approval changes to commercial supply and distribution. You will lead a team responsible for driving quality oversight, deviation management, and continuous improvement initiatives. Acting as a key escalation point, you will collaborate with global stakeholders to resolve complex quality issues. This position offers high visibility and impact within a global organization committed to delivering innovative and accessible medicines to patients worldwide.

Accountabilities:

Lead the US regional commercial product quality oversight for externally manufactured drug substances, drug products, and finished products across small and large molecules.
Ensure robust quality management systems are implemented and maintained at CMOs in compliance with GMP/GDP standards and global regulatory requirements.
Serve as the primary escalation point for CMO-related quality issues, including deviations, investigations, and CAPA implementation.
Review and approve change control strategies, post-approval changes, and annual product quality review (APQR) reports.
Oversee inspection readiness and execution, including regulatory inspections and CMO-hosted audits.
Manage quality agreements and ensure effective implementation, updates, and adherence across partners.
Lead and develop a regional quality team, ensuring adequate capability, compliance training, and performance management.
Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory CMC, and global Quality teams to ensure seamless product lifecycle management and supply continuity.
Support product recalls, batch release activities, and Process Performance Qualification (PPQ) for small molecule products.
Author and maintain relevant SOPs and ensure continuous alignment with evolving regulatory expectations.

Requirements:

Bachelor’s degree in Pharmacy, Biology, Chemistry, Engineering, or a related scientific field (Master’s degree preferred).
8+ years of experience in pharmaceutical or biotechnology quality roles within GMP/GDP-regulated environments.
At least 4+ years of leadership or people management experience, including team development and performance oversight.
Strong expertise in external supply quality, contract manufacturing oversight, and lifecycle management of pharmaceutical products.
Deep understanding of GMP regulations for both small and large molecule products, including manufacturing and quality systems.
Proven ability to manage complex quality investigations, CAPA systems, and regulatory interactions.
Strong cross-functional leadership skills with the ability to influence global stakeholders and drive alignment.
Excellent analytical thinking, problem-solving, and decision-making capabilities in highly regulated environments.
Strong communication skills with the ability to clearly present technical and quality-related information.
Willingness to travel regionally and internationally up to 30%.

Benefits:

Competitive base salary ranging from $143,400 to $193,400 annually, plus eligibility for bonus and incentive programs.
Equity opportunities through stock awards and employee stock purchase plan participation.
Comprehensive health coverage including medical, dental, and vision insurance.
Retirement savings plan (401(k)) with company match.
Health savings and flexible spending accounts (HSA/FSA).
Life insurance, disability coverage, and wellness programs.
Generous paid time off, holidays, and flexible work arrangements.
Parental leave and family support benefits.
Global, mission-driven environment focused on improving patient access to innovative medicines.

Product pay context

Based on 1,758 disclosed Product salaries on RoleSuite, the role pays a median of $178K/year, with most offers between $144K and $216K (10th–90th percentile: $115K–$260K).

This posting lists $143K–$193K, in line with the $178K market median.

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Associate Director, Commercial Product Quality US Regional Lead, External Supply Quality

Accountabilities:

Requirements:

Benefits:

Product pay context

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