Manager, Clinical Quality Assurance
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.
About the Position
Zymeworks is seeking a Manager, Quality Assurance to provide Quality oversight and support of Zymeworks clinical development programs and contribute to the development and ongoing management of the Zymeworks Quality Management System (QMS).
This position will be based in the Zymeworks Biopharmaceuticals, Inc. Seattle, Washington office and reports to the Director, Quality Assurance.
- 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.
- Manages clinical records and archiving management processes and procedures including trial master file (TMF) inventory and tracking.
Qualifications and Experience
- BS/MS in biological sciences, Chemistry or relevant discipline.
- A minimum of 5 to 7 years’ experience in the pharmaceutical/ biotech industry with increasing responsibility and relevant QA experience in a pharmaceutical or biotechnology environment.
- 2+ years of Good Clinical Practices (GCP) auditing experience.
- 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.
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.
How to Apply
If you are interested in this challenging opportunity, please apply online at https://zymeworks.bamboohr.co.uk/jobs/view.php?id=84. Due to the high volume of applicants, only those selected for interviews will be contacted.