Zymeworks

Senior Quality Assurance Specialist, Clinical

Quality - United States

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 Clinical Quality Specialist will play a key role in the support and management of the GCP programs to assure adherence to relevant US and Global regulations, guidelines and procedures. The successful candidate will be responsible for assisting with the development, scheduling, organizing and execution of internal and external audits per annual approved audit plans and support other CQA programs such as documentation, processes, and study support as needed.

Key Responsibilities

• Support of the GCP quality management programs and processes and as needed, conduct audits. Audits will include internal, clinical investigator sites, clinical vendors, CROs, TMFs and other audits to assess quality level and compliance with applicable GCP regulations.
• Schedule and track audits in accordance with approved audit plans.
• Assist in clinical trial site and vendor audit selection processes.
• Coordinate audits and pre-audit meetings with internal stakeholders and external parties.
• Compile and provide auditors with audit preparation documentation.
• Review and conduct internal and external audits in accordance with approved procedures and applicable standards and regulations.
• Prepare audit letters, other correspondence, and documentation related to audits.
• Create and maintain audit findings and CAPA database/tracking
• Assist in maintenance of the electronic supplier documentation system
• Assist in the coordination of vendor risk management and oversight processes including KQI performance reviews and issue resolution
• Compile quality metrics related to audits for dissemination at Quality Management Reviews
• Recommend and implement improvements to the audit programs based on new regulations, guidance documents, and industry standards.
• Support other CQA programs such as documentation, processes and study support as needed.
• Maintain required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations
• Support of other Clinical Quality projects as needed.

Education / Experience / Professional Requirements:

• Bachelor’s degree (or equivalent) in a scientific field.
• Minimum of 8 years of related experience, including at least 2 years working in QA or clinical operations/development
• Thorough knowledge of ICH Guidelines and GCPs including regulatory requirements for the conduct of clinical development programs.
• Strong work ethic, ability to communicate clearly and effectively both verbally and in writing, collaborative and self-motivated problem solver; thrives in both a small team environment and working independently.
• Embody and champion Zymeworks’ values: Innovate. Act with Integrity. Collaborate. Embrace Diversity. Care.
• Requires ability and willingness for approximately 25% travel - domestic & international, consistent with the project needs.
• Ability to build relationships and influence across disciplines and all levels
• Strong commitment to clinical research and business ethics
• Should be highly motivated, flexible, and have excellent organizational and communication skills.
• Ability to prioritize and balance work from multiple projects in parallel
• Demonstrated organization skills
• Able to communicate well at all levels in the organization

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Care. Embrace Diversity

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.

How to Apply

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.

Zymeworks

Zymeworks is an Equal Opportunity Employer

Submitted: 03/13/2021