Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) R&D and 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. 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

• Leadership & Partnership
• • Support Zymeworks Preclinical/R&D Quality Assurance (QA) programs to ensure development and implementation of Preclinical and R&D Quality strategy, processes, procedures, and standards in accordance with FDA Good Laboratory Practices (GLP), GLP OECD Principles, GCLP guidances, ICH guidelines and other global regulatory authority requirements, and industry practices.  
  • Actively lead/ participate on project teams by advising on GLP, GLP OECD, and related matters as the preclinical quality team lead on global programs, executes quality assurance activities for GLP toxicology studies and pre- clinical/ clinical  bioanalytical assay method validation and sample analysis including review of study protocols/ plans, reports, and data, documents for regulatory submissions, providing solutions when challenges arise. 
  • Establish strong relationships with internal Zymeworks stakeholders and external partners to ensure that the Preclinical/ R&D programs are adequately supported by QA.
  • Collaborate in processes such as but not limited t deviations, risk management, risk assessments, regulatory submissions, study documentation review, and CAPA management.
  • Develop relevant training materials and conducts training. 
  • Escalate quality and compliance issues to senior management and study teams in a timely manner for resolution.
•  Audits & Compliance Oversight
• • Proactively manage quality and compliance activities and establishes appropriate criteria, to assure compliance with regulations, guidelines, and standards.
  • Monitor regulatory and industry trends/actions such as GLPs, GCLP, GLP OECD, ICH guidelines, and drives implementation of change where necessary.
  • Host, manage, and/or support regulatory inspections, vendor audits, partner audits, and due diligence activities as applicable to regulated preclinical studies. 
  • Assure responses to observations are timely and appropriate to maintain good standing with regulatory agencies and partners.
  • Support development/ implementation of the preclinical/clinical bioanalytical laboratory (GLP/ GCLP) vendor management program and internal quality audit program.
  • Planning, scheduling, and conducting external vendor GLP/ GCLP audits.
  • Manage preclinical/clinical laboratory (GLP/ GCLP) vendor audit reports, communicates audit findings to key stakeholders for identification of root cause and development of Corrective and Preventive Action Plans (CAPAs).
  • Collaborate cross-functionally with QA, R&D, and other Internal stakeholders to identify quality/ compliance risks with potential for systemic impact, assure appropriate risk analysis/ mitigation and to provide the context to drive informed critical decision making.
  • Monitor and interprets compliance issues identified across programs and assists with periodic communication of the state of compliance to leadership by co-leading or participating In the Quality Management Review.

What You'll Bring

• BS/MS in Biological Sciences, Chemistry or relevant discipline and a minimum of:
• • Ten (10) years’ related experience in the pharmaceutical/biotechnology industry with increasing responsibility and relevant QA experience or an equivalent combination of education and experience.
  • Five (5) years of preclinical GLP (toxicology and bioanalytical) and clinical bioanalytical laboratory/ GCLP-directed quality, audit, and vendor management experience
• Relationship building skills with the ability to work collaboratively as a member of a cross-functional team and working with external CROs
• Excellent organizational and communication skills
• Works effectively in a challenging, milestone-driven environment, to independently analyze/resolve moderate to complex issues, seeking guidance as needed. 
• Advanced working knowledge and demonstrated proficiency in:
• • Quality principles, regulatory requirements, industry standards and guidelines with respect to domestic and international industry practices (e.g., GLP, GCLP, CLIA, ICH M10, Bioanalytical Method Validation Guidances).
  • QA and basic scientific/technical concept for the advancement of therapeutics throughout different phases of the drug development process (R&D, GLP studies, clinical study development) and biotechnology.
  • Creating QMS SOPs, good documentation practices, and quality review methods.
• Ability and willingness for approximately 20% travel (domestic & international), consistent with the project needs.
• Proficiency with software applications such as MS Office, SmartSheet and Veeva.

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 base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. 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).

Our total rewards package that includes: 

• Industry leading vacation and paid time off
• Exceptional medical, dental and vision benefits by country
• Zymelife health and wellness benefits
• Matching RRSP / 401K / Penion program
• Employee Share Purchase Program
• Employee Equity Program
• Paid time off to volunteer in your community

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.