Associate Director, Quality Control

Xenon Pharmaceuticals•Needham, MA

8d•Hybrid

About The Position

We are seeking an experienced Associate Director to lead Quality Control activities supporting clinical and commercial drug substance (DS) and drug product (DP) programs in accordance with ICH and cGMP requirements. The ideal candidate will have a strong background in small molecules, with experience spanning early to late clinical phases through registration, PPQ, and commercial stages. This role requires expertise in managing analytical testing, specifications, stability program, reference standards, investigations, and quality control oversight across DS and DP manufacturing and testing campaigns. The ideal candidate will be collaborative, science and data driven, and thrive working in a fast-paced environment. This position reports to the Director, Quality Control and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. Hybrid positions require a minimum of two onsite days per week.

Requirements

An undergraduate degree in life sciences, with 8+ years 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.
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 is required.
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.

Nice To Haves

Experience auditing external laboratories, FDA/EMA inspections, and inspection readiness is preferred.
Prior experience with IND, BLA, and/or CTA CMC submissions is preferred.

Responsibilities

Manage master specifications for starting materials, reference standards, API, and drug products for assigned clinical/commercial program(s).
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 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.
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.
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.
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).
Manage the review and approval workflow for feasibility/comparability studies, validation protocols, reports, and test methods with internal experts and external partners.
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.
Ensure effective working relationships with external laboratories and CMOs, participate in remote audits, and perform on-site audits as required.
Effectively collaborate with colleagues in Drug Product and API groups, such that deliverables are optimal for use in clinical trial material.
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).
Assess team capacity and lead the assigned team to ensure project deliverables are met, including management of performance reviews.
Other duties as required from time to time.
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.
Other duties as assigned.