Zymeworks is a 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.
About the Position
Zymeworks is seeking a Senior QA Specialist, Quality Assurance - GMP to provide Quality oversight of Zymeworks’ clinical development programs and contribute to the development and ongoing management of the Zymeworks Quality Organization.
This position will report to the Manager of Quality Assurance, GMP (Good Manufacturing Practices) and will be based in Seattle, Wa.
Key Responsibilities
- Manages tactical QA decisions and actions as a key member of CMC development teams; provides feedback on project strategy planning
- Actively tracks project timelines and key QA deliverables to ensure compliance expectations are met in a timely manner.
- Leads GMP investigations and collaborates with technical teams and external contacts to align compliance expectations and support follow up actions.
- Primary contact as a CMO point of contact for QA oversight of external manufacturing, including biologics, small molecule and conjugated products, drug product and labeling/packing operations.
- Makes disposition recommendations to the disposition manager based on reviews of executed batch records and supporting data.
- Ensures that GMP lot file documents are accurately and properly completed by vendors, including all batch related deviations to facilitate timely batch dispositions.
- Reviews and approves external controlled documents for GMP compliance, such as master batch records, test methods and specifications.
- Collaborates with technical leads to ensure executed batch records, release and stability data are reviewed and trended to ensure GMP compliance.
- Responds to, participates in, and may lead corrective action implementation for identified quality assurance issues including internal/external audits actions.
- Reviews and provides QA feedback for internal and external change requests for GMP compliance and to interdepartmental Change Review Board proceedings.
- Revises Standard Operating Procedures as needed.
- Provides guidance and mentorship to other QA associates.
- Proactively examines/reviews systems and processes to identify/assess areas for review, improvement, change, or elimination with a focus to simplify and standardize processes. May lead and drive improvements as required.
Qualifications and Education
- Bachelor’s degree in Biology, Chemistry or another relevant discipline
- 8+ years’ experience in a GMP-regulated work environment (Quality Assurance, Quality Control, Biologics/Pharmaceutical Manufacturing, etc.)
- Hands-on experience reviewing GMP manufacturing batch records.
- At least 4 years’ experience providing QA oversight of GMP manufacturing, utilizing a risk-based approach to clinical trial material manufacturing, is preferred. Knowledge of FDA/EU/Health Canada GMP Quality Requirements for GMP manufacturing
- Demonstrated knowledge of Quality Risk Management as applicable to various stages of clinical development
- Positive, enthusiastic, and customer service oriented interpersonal skills
- 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 learn and use project management tools to track actions and timelines.
- Excellent technical writing and verbal communication skills.
- Domestic and international travel (~10%) as needed.
- Strong oral, written and listening skills.
- Ability to assess priorities and successfully manage workload to timelines.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Understanding of basic scientific/technical concepts and ability to analyze moderate to complex data and glean basic information from the data.
- Previous experience with electronic quality systems such as for document control, training, and change control (preferred).
Why work for us?
Innovation. Act with Integrity. Collaboration. Care
We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.
#LI-PT1