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 highly-motivated professional who is looking to grow their career with our company.
This position will report to the Associate Director and will be based in Seattle, WA or Vancouver, BC.
- Provides Quality oversight and support of Zymeworks clinical development programs.
- Supports the Zymeworks Clinical Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems in accordance with E6 (R2).
- Executes on and/or provides oversight of quality monitoring and assurance of clinical trial execution of Zymeworks sponsored protocols.
- Executes on and/or provides oversight of clinical investigator audits, documentation audits and other study-specific or process audits.
- Engages with study teams and functions for proactive inspection readiness across all clinical programs.
- Conducts external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities.
- Communicates audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes.
- Tracks, reviews, approves, and assesses the efficiency of CAPAs.
- Develops relevant training materials and conducts training.
- Assists with the preparation, coordination, and management of regulatory agency inspections.
- Monitors regulatory and industry trends/actions and reports regularly to Quality Assurance management.
- Interfaces and collaborates with internal departments and external Contract Research Organizations.
Education and Experience:
- BS/MS in Biological Sciences, Chemistry or relevant discipline and a minimum of 5 to 7 years of experience in the pharmaceutical/biotech industry with increasing responsibility and relevant QA experience in a pharmaceutical or biotechnology environment or an equivalent combination of education and experience.
- Two years of Good Clinical Practices (GCP) auditing experience.
Skills and Abilities:
- In-depth knowledge and clear understanding of GCP regulations and industry standards.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
- Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.
- Working knowledge of GCP principles with respect to domestic and international regulations and guidance (e.g. FDA, EMA, Health Canada and ICH).
- Understanding of quality systems and how quality systems are designed and operated to satisfy regulatory requirements.
- Experience in drafting, reviewing and approving GCP related documents (SOPs, reports, etc.).
- Experience working with Contract Research Organizations.
- Knowledge of drug development processes.
- Familiarity with electronic Quality Management systems and electronic records.
- Ability to independently analyze/resolve moderate to complex issues.
- Demonstrated proficiency in application of QA principles, concepts, industry practices and standards.
- Problem solving skills, effective written and verbal communication skills.
- Excellent documentation skills and attention to detail. Orientation for meticulous work.
- Requires an ability and willingness for approximately 25% travel - domestic & international, consistent with the project needs.
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.
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.