Associate Director, Clinical Quality Assurance

Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) 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.
Why Work With Us
Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area.
Key Responsibilities
Leadership & Partnership

• Supports 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.
• 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 plans in collaboration with Clinical Development.
• Establishes 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;
• Six (6) 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.

Total Rewards
We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.
The US base salary range for this full-time position is $158,000 - $242,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.
The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate's location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. This role is also eligible for a competitive benefits package that includes:

• Industry leading vacation and paid time off
• Excellent health and wellness benefits
• Zymelife health and wellness benefits
• Paid time off to volunteer in your community
• Matching RRSP / 401K program
• Employee Share Purchase Program
• Employee Equity Program

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.
NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.
Date: Feb 7, 2024