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.
Zymeworks is seeking an Associate Director, Clinical Quality Assurance to provide Quality oversight in support of Zymeworks' clinical development programs and contribute to the development and ongoing management of the Zymeworks Quality Management System (QMS). This position will be based in Seattle and will report to the Director, Quality Assurance.
Leadership & Partnership
Leads the Zymeworks Clinical Quality Assurance team to ensure development and implementation of clinical Quality processes, procedures and standards as required by applicable regulations.
Provides ongoing development of the Clinical Quality Assurance (CQA) team, including staff selection, work assignments, goal completion, and performance management.
Establishes strong partnership/relationship with internal Zymeworks stakeholders and interacts frequently with senior management.
Recognized as a senior strategic GCP Quality resource.
Establishes and ensures adherence to budget, schedules and work plans.
Oversee Clinical Vendor Audit & Compliance Monitoring Programs
Develops and implements the clinical vendor audit plan in collaboration with Clinical Development.
Determines acceptability of potential clinical vendors.
Evaluates existing clinical vendors for compliance with GCP regulations, guidelines, and standards.
Ensures consistency of audit reports (i.e. observations and ratings).
Provides Quality Assurance leadership and influence to product development teams.
Acts as the company-wide resource for Clinical Quality GCP, ICH guidelines, and Clinical Operations SOPs
Assess State of GCP Compliance
Supervises and oversee the analysis 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 Quality Assurance 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 analysis for key stakeholders to make critical decisions.
Regulatory Inspection / External Audit Support
Represents Clinical Quality Assurance during GCP 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.
Qualifications and Experience
Bachelor's degree in Biology, Chemistry or other relevant discipline;
A minimum of eight (8) years' related experience in the pharmaceutical/biotech industry with demonstrated increasing responsibility and relevant Quality Assurance experience or an equivalent combination of education and experience.
Four (4) years of Good Clinical Practices (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 Standard Operating Procedures and working with Contract Research Organizations.
Advanced understanding of Quality principles, GCP regulatory requirements, industry standards and guidelines.
Strong understanding of Good Documentation Practices and GCP quality review methods.
Demonstrated ability to interact with cross-functional teams in order to ensure the compliance of the GCP operations.
Understanding of basic scientific/technical concepts.
Strong oral, written and listening skills.
Proficiency with MS Office.
Why Work for Us?
Zymeworks' employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.