Associate Director, Analytical Development & QC

The Opportunity:

Associate Director QC will be responsible for oversight of the Quality Control testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios. Partner cross-functionally within PDM (drug substance, drug product, CMC Regulatory Affairs) and QA to manage method transfers, validations, and data oversight aligned with development and production timelines. Key responsibilities include vendor oversight, data review, external audits, and management of GMP-related exceptions (e.g., deviations, CAPAs, OOS/OOT, change controls).

Oversees designation of critical quality attributes, specification setting, and trending of method and product performance. Provides direction on method transfers and validations, ensuring compliance with regulatory standards and laboratory control requirements.

Responsibilities:

• Lead and/or coordinate QC activities of late phase and commercial programs, including but not limited to commercial launch readiness, in-process control test, final release test, PAI readiness and inspection as needed.

• Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs).

• Manage quality events related to commercial QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.

• Author and/or review commercial QC related documents, including methods, protocols, reports and memos.

• Manage commercial phase reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory.

• Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals.

• Coach, mentor, and engage team to ensure business goals and development plans are met.

• Establish and monitor operational metrics to track performance and identify trends

• Monitor emerging regulatory requirements and assess organizational impact.

• Lead remediation efforts for identified gaps and drive continuous improvement initiatives.

• Excellent interpersonal, negotiation, and influencing skills with the ability to manage multiple priorities and lead change across all organizational levels.

 Required Experience, Skills and Education:

• Bachelor’s degree in a scientific discipline with 15+ years of experience in pharmaceutical QC operations across development and commercial stages. Alternatively, a Master’s degree with 12+ years or a PhD with 10+ years is acceptable.

• Solid understanding of relevant global and regional regulatory guidelines (FDA, EU, and ICH, etc.) as applicable to QbD, commercial process validation, commercial product launch, commercial manufacture sampling and testing, and post-approval quality control requirements.

• Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.).

• Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.

• Strong problem-solving skills with sound technically driven decision-making ability.

Preferred Skills: 

• Small molecule experience is required; biologics experience is highly preferred.

• Effective written and verbal communication skills and interpersonal skills.

• Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems .

• Ability to multi-task and thrive in a fast-paced innovative environment.

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