Director Clinical Quality Assurance

Key Responsibilities

Leadership & Partnership

• Leads the Zymeworks Clinical Quality Assurance (CQA) team to ensure development and implementation of Clinical Quality strategy, processes, procedures and standards as required by applicable regulations.
• Leads and develops the CQA team, including staff selection, work assignments, goal completion, and performance management.
• Establishes strong partnerships/relationships with internal Zymeworks stakeholders to ensure that the clinical programs are adequately supported by the CQA.
• Advises on strategic GCP quality questions.

Oversee Clinical Vendor Audit & Compliance Monitoring Programs

• Designs and implements the clinical vendor audit plan in collaboration with Clinical Development.
• Establish the quality and compliance criteria -related acceptability of potential clinical vendors.
• Oversees the evaluation of existing clinical vendors to assure continued compliance with GCP regulations, guidelines, and standards.
• Oversees the review of site and vendor audit reports (i.e. observations and ratings) and communicates findings to management.
• Is a resource for current and planned GCPs, ICH guidelines, and Clinical Operations SOPs.

Assess State of GCP Compliance

• Supervises and oversees the analyses of audit program results, quality issues and investigations in order to optimize regional operations and global state of compliance.
• Collaborates with Quality Management and Quality Systems QA to identify and mitigate GCP quality and compliance issues with potential systemic impact.
• Monitors and interprets compliance issues identified across clinical programs and elevates systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution.
• Provides appropriate risk analyses for key stakeholders to make critical decisions.
• Communicates that state of compliance to executive management by establishing a Quality Management Review.

Regulatory Inspection / External Audit Support

• Leads GCP-directed regulatory inspections and audits.
• Assures observation responses are timely and appropriate to maintain good standing with regulatory agencies and partners.
• Coaches and educates external sites and cross functional Zymeworks staff in clinical regulatory inspection readiness activities.
  

Education and Experience

• Bachelor’s degree in Biology, Chemistry or other relevant discipline;
• A minimum of ten (12) years’ related experience in the pharmaceutical/biotech industry with demonstrated increasing responsibility and relevant QA experience or an equivalent combination of education and experience;
• Eight (8) years of GCP auditing experience.

Skills and Abilities

• Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional team. Ability to establish and maintain effective working relationships.
• Working knowledge of regulatory guidelines and expertise in Quality for the advancement of therapeutics through different phases of development.
• Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
• Proficiency with creating SOPs and working with Contract Research Organizations.
• Advanced understanding of Quality principles, GCP regulatory requirements, Good Documentation Practices, and GCP quality review methods.
• industry standards and guidelines.
• Demonstrated ability to interact with cross-functional teams to ensure the compliance of the GCP operations.
• Understanding of basic scientific/technical concepts.
• Knowledge of GLP as applicable to non/pre-clinical studies preferred.
• Strong oral, written, listening skills Proficiency with MS Office.