Senior Manager, GMP Quality Assurance

Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop antibody-based therapeutic candidates. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and Redwood City, CA. 

Why Work With Us

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This role will be located in Bellevue, WA and is hybrid with a minimum of 3 days per week onsite.

What You'll Do

• Manage and implement the supplier management program.
• Manage and implement the quality compliance program which includes internal/external audits, inspection management and product withdrawal processes.
• Perform internal and external audits of Zymeworks quality systems and GMP suppliers.
• Manage, oversee and support Qualified Person’s declaration, certification and requests.
• Facilitate and support Quality Assurance (QA) related tasks and projects by actively tracking project timelines and key QA deliverables to ensure that compliance and quality expectations are met in a timely manner.
• Author policies, SOPs, and work instructions to ensure a robust QMS
• Support continuous improvement with a focus to simplify, build efficiencies and standardize processes supporting QA/Quality Systems (QS).
• Management of direct reports, as appropriate.
• Support Manufacturing Quality Assurance (MQA) for batch record review and lot release.
• Support tactical QA decisions and actions as a key member of the Quality team
• Lead project teams and/or provides feedback on project strategy planning as needed.
• Collaborate cross functionally with internal stakeholders to support quality related initiatives and resolution of quality events through closure.
• Participate in relevant meetings and oversee the implementation of assigned action items.  
• Monitor, measure and report defined data and metrics for management review.
• Act as a subject matter expert for the interpretation and application of GMP/GDP regulatory requirements for manufacturing pharmaceutical products.
• Support and perform additional QA responsibilities, as applicable.  
• Domestic and international travel up to 25%.

What You'll Bring

• Bachelor’s degree in biology, chemistry or other relevant discipline.
• Minimum of 10 years of experience in a pharmaceutical/biotech GMP regulated work environment specific to clinical and commercial drug products (e.g., Biologics, Antibody Drug Conjugates, Small molecules, oncological therapeutics, autoimmune therapeutics).
• Extensive experience performing quality audits of GMP suppliers including small molecule and biologics manufacturers, contract testing labs and logistics service providers.
• Extensive experience managing GMP suppliers.
• Experience working cross functionally with multiple functional area stakeholders (e.g., Clinical Operations, Regulatory Affairs, Process Development, Manufacturing, Quality Control, Supply Chain) to support the manufacturing and supply of GMP materials for Zymeworks Clinical trials.
• Experience hosting and supporting partner audits and/or regulatory inspections.
• Experience with the management, mentoring and development of staff.
• Knowledge of the product development lifecycle for clinical and commercial drug products.
• Strong understanding, interpretation and application of global GMP/GDP r