Senior Manager

Description

• Review, manage all analytical/non-analytical results for product release, and stability, including OOS and OOT observations. Organize and file internal and external quality control data, protocols, and reports.
• Lead the assigned program’s stability activities, including trending, statistical evaluation, and scientific interpretation of stability data to assess product performance throughout its lifecycle, support shelf-life extensions and expiry dating justifications, and proactively identify and evaluate emerging stability risks and trends.
• Manage the reference standard program for the assigned clinical/commercial program at dedicated external labs, including qualification and distribution of reference standards to all manufacturing & testing facilities.
• Manage master specifications for starting materials, reference standards, API, and drug products for assigned clinical/commercial program(s).
• Manage stability studies for reference standards, API, and drug products for assigned programs. Compile stability protocols and monitor all stability data, including shelf-life trending and extensions.
• Lead investigations and draft reports for out-of-specification (OOS) and out-of-trend (OOT) results during release and stability testing in close collaboration with internal teams and external testing labs.
• Manage the review and approval workflow for feasibility/comparability studies, validation protocols, reports, and test methods with internal experts and external partners.
• Lead quality control checks on the CMC sections of regulatory submissions (e.g., Investigational New Drugs (INDs), Clinical Trial Applications (CTAs), and New Drug Applications (NDAs).
• In collaboration with QA, manage internal release documents for drug substances, drug products, and reference standards, including Certificate of Analysis and Certificate of Testing in collaboration with quality assurance.
• Effectively collaborate with colleagues in Drug Product and API groups, such that deliverables are optimal for use in clinical trial material.
• Ensure effective working relationships with external laboratories and CMOs, participate in remote audits, and perform on-site audits as required.
• Provide technical knowledge of quality control to support the transfer of new drug candidates from research/discovery groups to the CMC drug development team.
• Oversee the movement of samples between external testing partners and CMOs for tech transfers, release, and stability testing of assigned program(s).
• Engage in and ensure compliance with appropriate quality functions, including deviations, change controls, and CAPAs.
• May recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some international travel may be required.

Qualifications

Highest qualification: University

• An undergraduate degree in life sciences, with 5+ years (Senior Manager level) or 8+ years (Associate Director level) of relevant management experience in the pharmaceutical industry (small molecules and/or biologics).
• Previous experience working with external testing laboratories; independently and influences in a fast-paced environment, while exhibiting a strong quality mindset.
• Comfortable working across locations and time zones.
• Experience auditing external laboratories, FDA/EMA inspections, and inspection readiness is preferred.
• Strong experience with quality control testing, stability program management in accordance with ICH guidelines, master specifications, method validations, investigations (OOS/OOT), batch release processes, and quality management systems are required.
• Prior experience with IND, NDA and/or CTA CMC submissions is preferred; knowledge of cGMP and the US, Canadian, and EU regulatory environments.
• Collaboration and inclusion between external testing labs and cross-functional CMC teams are essential.
• Excellent oral and written communication skills and previous team leadership experience.