Senior Manager GLP Quality Assurance

Work Requirement

This role will be based out of our Bellevue, WA office and is hybrid with a minimum of 3 days per week onsite. 

Key Responsibilities

Leadership & Partnership

• Supports Zymeworks Preclinical/R&D Quality Assurance (QA) programs to ensure development and implementation of Preclinical and R&D Quality strategy, processes, procedures, and standards in accordance with FDA Good Laboratory Practices (GLP), GLP OECD Principles, GCLP guidances, ICH guidelines and other global regulatory authority requirements, and industry practices.  
• Actively leads/ participates on project teams by advising on GLP, GLP OECD, and related matters as the preclinical quality team lead on global programs, executes quality assurance activities for GLP toxicology studies and pre- clinical/ clinical  bioanalytical assay method validation and sample analysis including review of study protocols/ plans, reports, and data, documents for regulatory submissions, providing solutions when challenges arise. 
• Establishes strong relationships with internal Zymeworks stakeholders and external partners to ensure that the Preclinical/ R&D programs are adequately supported by QA.
• Collaborates in processes such as but not limited to deviations, risk management, risk assessments, regulatory submissions, study documentation review, and CAPA management.
• Develops relevant training materials and conducts training. 
• Escalates quality and compliance issues to senior management and study teams in a timely manner for resolution.

Audits & Compliance Oversight

• Proactively manages quality and compliance activities and establishes appropriate criteria, to assure compliance with regulations, guidelines, and standards.
• Monitors regulatory and industry trends/actions such as GLPs, GCLP, GLP OECD, ICH guidelines, and drives implementation of change where necessary.
• Hosts, manages, and/or supports regulatory inspections, vendor audits, partner audits, and due diligence activities as applicable to regulated preclinical studies. 
• Assures responses to observations are timely and appropriate to maintain good standing with regulatory agencies and partners.
• Supports development/ implementation of the preclinical/clinical bioanalytical laboratory (GLP/ GCLP) vendor management program and internal quality audit program.
• Planning, scheduling, and conducting external vendor GLP/ GCLP audits.
• Manages preclinical/clinical laboratory (GLP/ GCLP) vendor audit reports, communicates audit findings to key stakeholders for identification of root cause and development of Corrective and Preventive Action Plans (CAPAs).
• Collaborates cross-functionally with QA, R&D, and other Internal stakeholders to identify quality/ compliance risks with potential for systemic impact, assure appropriate risk analysis/ mitigation and to provide the context to drive informed critical decision making.
• Monitors and interprets compliance issues identified across programs and assists with periodic communication of the state of compliance to leadership by co-leading or participating In the Quality Management Review.
   

Education and Experience

• BS/MS in Biological Sciences, Chemistry or relevant discipline and a minimum of:
  • Ten (10) years’ related experience in the pharmaceutical/biotechnology industry with increasing responsibility and relevant QA experience or an equivalent combination of education and experience.
  • Five (5) years of preclinical GLP (toxicology and bioanalytical) and clinical bioanalytical laboratory/ GCLP-directed quality, audit, and vendor management experience

Skills and Abilities:

• Relationship building skills with the ability to work collaboratively as a member of a cross-functional team and working with external CROs
• Excellent organizational and communication skills
• Works effectively in a challenging, milestone-driven environment, to independently analyze/resolve moderate to complex issues, seeking guidance as needed. 
• Advanced working knowledge and demonstrated proficiency in:
  • Quality principles, regulatory requirements, industry standards and guidelines with respect to domestic and international industry practices (e.g., GLP, GCLP, CLIA, ICH M10, Bioanalytical Method Validation Guidances).
  • QA and basic scientific/technical concept for the advancement of therapeutics throughout different phases of the drug development process (R&D, GLP studies, clinical study development) and biotechnology.
  • Creating QMS SOPs, good documentation practices, and quality review methods.
• Ability and willingness for approximately 20% travel (domestic & international), consistent with the project needs.
• Proficiency with software applications such as MS Office, SmartSheet and Veeva.