Senior Quality Assurance Specialist, GMP Auditor

Quality Seattle, Washington


Description

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.

About the Position

The Senior Quality Assurance Specialist, GMP Auditor will play a key role in the support and execution of the GxP audit program to ensure Zymeworks internal Quality Management System (QMS) process and external suppliers adhere to and maintain compliance with applicable US, European and global pharmaceutical GxP regulations, standards and guidelines. The successful candidate will be responsible for audit scheduling, planning, organization, and execution of internal and external audits per the annual audit plan and ad hoc audits as requested.

This role will report to the Associate Director, Quality Compliance and will be based in Seattle, WA.

Key Job Responsibilities:

  • Will lead external audits of Zymeworks suppliers including drug product, drug substance, contract testing laboratories, logistics service providers, transportation service providers, computer systems/software providers and internal quality system process audits.
  • Assess internal QMS and external supplier compliance with the applicable global GxP regulations, standards and guidelines and to identify top compliance risks.
  • Provides leadership toward escalating internal and external supplier compliance issues resulting from audit findings.
  • Leads the assessment of action plans to correct deficiencies.
  • Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
  • Serves as subject matter expert on global regulatory requirements and inspectional commitments, as applicable.
  • Provide support for the supplier management program.
  • Lead or participate in negotiation of Quality Agreements with suppliers.
  • Support the regulatory inspection readiness and management program.
  • Provides technical support/compliance review of Zymeworks documents and quality records including providing support for resolution of compliance issues, if/when necessary.
  • Serve as Quality Compliance representative or delegate on cross-functional teams in order to achieve goals.
  • Will compile audit and inspection data for creating metrics reports.
  • Supports continuous improvement initiatives, programs and projects.

Qualifications and Experience:

  • Bachelor’s degree (or equivalent) in a scientific field.
  • Minimum of 8 years of related experience working in QA or pharmaceutical manufacturing operations.
  • Preferred minimum 5 years working full-time as a GxP auditor with experience in the areas of clinical and commercial drug substance and sterile drug product manufacturing, testing, packaging/labeling and warehouse/distribution operations.
  • An equivalent combination of education and experience may be considered.

Skills and Abilities:

  • Thorough understanding and interpretation of pharmaceutical GxP regulations, guidelines and standards, including but not limited to US FDA 21CFR11, 210/211, 600, EU Vol 4. Chapters/Annexes, ICH, PIC/s and WHO.
  • Ability and willingness to travel approximately 35% - domestic & international.
  • Strong writing skills including the ability to write effective audit findings supported by objective evidence and linked to a deficiency to an applicable regulation.
  • Strong verbal communication skills, including the ability to articulate complex problems and situations.
  • Demonstrated ability to work well independently and on teams.
  • Experience training others on the audit process.
  • Proven success working cross-functionally with all levels of management.
  • Able to manage successfully competing priorities in a dynamic environment.
  • Able to manage multiple projects simultaneously.
  • Professional Certifications such as ASQ-CQA or equivalent, desired.

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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