Senior Manager, Third Party Gmp Quality Assurance

Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.
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.
Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area.
Work Requirement
This role can be based out of our Bellevue, WA or Bay Area offices and is hybrid with a minimum of 3 days per week onsite.
Key Responsibilities

• Act as a primary GMP QA contact with Zymeworks GMP Third Parties.
• Participate in Third Party meetings and oversee the implementation of assigned action items.
• Facilitate and support Third Party QA-related tasks by actively tracking project timelines and key QA deliverables to ensure that compliance and quality agreement expectations are met in a timely manner.
• Facilitate and support GMP product/material release for Third Party supply including GMP batch record and data review to ensure compliance with approved procedures and communicate and resolve discrepancies with Third Parties.
• Manage the negotiation, review and execution of GMP Third Party Quality Agreements.
• Support and manage GMP Third Party investigations, change controls, CAPA, product complaints and follow-up actions.
• Collaborate cross functionally with internal stakeholders to support Third Party quality related initiatives and resolution of quality events through closure.
• Monitor, measure and report defined Third Party QA data and metrics for management review.
• Assess, author, and implement processes, policies, SOPs, and work instructions to ensure a robust QMS and support continuous improvement with a focus to simplify, build efficiencies and standardize processes supporting Third Party GMP QA.
• Support tactical QA decisions and actions as a key member of the GMP QA team; leads project teams and/or provides feedback on project strategy planning as needed.
• Support and perform additional GMP QA responsibilities including but not limited to conducting GMP/GDP audits of Zymeworks Suppliers and support of audit/inspection readiness activities as directed.

Education and Experience

• Bachelor's degree in biology, Chemistry or other relevant discipline.
• Minimum of 10 years of experience in a GMP regulated work environment specific to clinical and commercial human drug products (e.g., Biologics, Antibody Drug Conjugates, Small molecules).
• At least 5-7 years' experience providing Third Party QA oversight and working cross functionally with multiple functional area stakeholders (e.g., Process Development, Manufacturing, Quality Control, Supply Chain) to support the manufacturing and supply of GMP materials.
• Direct experience with GMP/GDPs for clinical and commercial drug products.
• Previous experience owning, managing and implementing quality events (e.g., Deviations, CAPA, Change Control, Product Withdrawal, Complaints).
• 5 Years experience executing GMP/GDP audits as a lead auditor, hosting or supporting audits/regulatory inspections, and supporting.
• Previous experience managing people and teams.
• External auditor certification (e.g., ASQ-CQA) and oncological therapeutics experience, preferred.

Skills and Abilities

• Ability to work independently and proactively to manage, execute and deliver on tasks in accordance with defined to timelines.
• Ability to work as part of a high performing team and collaborate effectively with staff at all levels and establish highly functional relationships within and outside the company.
• Ability to define problems, collect data, establish facts, and analyze complex data and information to draw valid conclusions.
• Excellent technical writing and communication building skills.
• Strong understanding, interpretation and application of global GMP/GDP regulations, standards, guidelines (e.g., USFDA, EMA, APAC, LATAM, Pharmacopeia, PIC/s, ICH etc.) and best quality practices regarding biotech and parenteral pharmaceutical products.
• Experience with electronic quality management systems such as for document control, training, and quality events, audits and approved supplier management.
• Domestic and international travel (~10%)

Total Rewards
We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.
The US base salary range for this full-time position is $127,000 - $195,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.
The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate's location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. This role is also eligible for a competitive benefits package that includes:

• Industry leading vacation and paid time off
• Excellent health and wellness benefits
• Zymelife health and wellness benefits
• Paid time off to volunteer in your community
• Matching RRSP / 401K program
• Employee Share Purchase Program
• Employee Equity Program

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.
NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.
Date: Dec 10, 2023