Manager/Sr. Manager, GMP Quality Assurance

Technical & Manufacturing Operations · Seattle, Washington
Department Technical & Manufacturing Operations
Employment Type Permanent - Full Time
Minimum Experience Experienced

 

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.

 

About the Position

 

Zymeworks is seeking a a highly motiviated professional to join our Quality Assurance team as a Manager or Senior Manager, Quality Assurance, GMP Quality Assurance depending on experience and qualifications.

 

This position will be based in Seattle, Washington and will report to the Director, Quality Assurance.

 

 

Key Responsibilities

 

• Supports the Zymeworks GxP Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems.

• Manages the internal and external Deviation/CAPA system.

• Manages the change control process and system.

• Writes, revises and reviews standard operating procedures.

• Contributes to the development of underlying systems to standard operating procedures

• Participates in the Zymeworks audit program (internal and external).

• Participates in external and internal audits to assess compliance with GMP requirements, investigational plans and company standards for clinical trial-related activities.

• Conducts batch record review of batches manufactured by Contract Manufacturing Organizations.

• Manages the Zymeworks’ controlled document management system (electronic and paper).

• Monitors regulatory and industry trends/actions and reports regularly to Quality Assurance management.

• Interfaces and collaborates with internal departments and external Contract Management Organizations.

• Fosters effective and collaborative working relationships with fellow employees, management and external partners.

 

Qualifications and Education

 

BS/MS in Biological Sciences, Chemistry or relevant discipline and a minimum of 8 to 10 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.

 

Skills and Abilities

 

• 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 cGMP principles with respect to domestic and international regulations and guidance (e.g. FDA, EMA, Health Canada and ICH)

 

 

Why work for us?

 

Innovation. Act with Integrity. Collaboration. 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.

 

To learn more about Zymeworks Inc. and our current openings, please visit our website at https://zymeworks.bamboohr.com/jobs/.


 

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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  • Location
    Seattle, Washington
  • Department
    Technical & Manufacturing Operations
  • Employment Type
    Permanent - Full Time
  • Minimum Experience
    Experienced