Manager, Clinical Quality Assurance

Quality United States


Description

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.

Zymeworks is seeking a highly motivated Manager, Clinical Quality Assurance who is looking to grow their career with our company.

This position will report to the Associate Director, Clinical Quality Assurance and will work remotely in the United States.

Job Description and Responsibilities

  • Provide Quality oversight and support of Zymeworks clinical development programs. 
  • Support the Zymeworks Clinical Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems in accordance with E6 (R2).  
  • Execute on and/or provides oversight of quality monitoring and assurance of clinical trial execution of Zymeworks sponsored protocols. 
  • Execute on and/or provides oversight of clinical investigator audits, documentation audits and other study-specific or process audits. 
  • Engage with study teams and functions for proactive inspection readiness across all clinical programs. 
  • Conduct external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities. 
  • Communicate audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes. 
  • Track, review, approve, and assess the efficiency of CAPAs. 
  • Develop relevant training materials and conducts training. 
  • Assist with the preparation, coordination, and management of regulatory agency inspections. 
  • Monitor regulatory and industry trends/actions and reports regularly to Quality Assurance management. 
  • Interface and collaborate with internal departments and external Contract Research Organizations.

Qualifications

  • BS/MS in Biological Sciences, Chemistry or relevant discipline and a minimum of 5 years of experience in the pharmaceutical/biotech industry, with increasing responsibility and relevant QA experience in a pharmaceutical or biotechnology environment.
  • A minimum of 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. 
  • An equivalent combination of education and experience may be considered.
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

Additional Information

  • Requires an ability and willingness for approximately 25% travel - domestic & international, consistent with the project needs. 

Why work for us?

At Zymeworks, we stand for innovation, integrity, collaboration and 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.

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