Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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.
Zymeworks is seeking a Specialist I, 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 Senior Manager, GMP Quality Assurance and will be based in Seattle, WA.
Roles and 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 a disposition recommendation to head of quality based on Reviews executed batch records and data to ensure compliance with approved controlled documents and communicates to resolve discrepancies with contracted vendors.
- 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 investigations and corrective action implementation for identified quality assurance issues including internal/external audits actions
- Creates audit plans and agendas, documentation of observations, authoring of reports and evaluation of corresponding audit commitments to support internal and external GMP audits.
- 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 Experience
- Bachelor’s degree in Biology, Chemistry or other relevant discipline
- 6+ 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).Ability to define problems, collect data, establish facts, and draw valid conclusions.
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.Apply Now