Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) R&D and 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. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and Redwood City, CA. 

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.

This role can be located in Bellevue WA or Redwood City CA and is hybrid with a minimum of 3 days per week onsite.

What You'll Do

Leadership & Partnership

• Support the Zymeworks GCP Quality Assurance team to ensure development and implementation of Clinical Quality strategy, processes, procedures and standards as required by applicable regulations.
• Establish strong partnerships/relationships with internal Zymeworks stakeholders and external partners/ Contract Research Organization (CRO) representatives to ensure that the clinical programs are adequately supported by GCP Quality Assurance.
• Advise on strategic GCP quality questions.
• Cross functional role support to GLP Quality, when needed.
• Collaborate in processes such as but not limited to review of deviations, risk management, risk assessments, regulatory submissions, study documentation review, and CAPA management.
  

Oversee Investigator Site and Clinical Vendor Audits & Compliance Monitoring Programs

• Design and implement the clinical vendor audit plans in collaboration with the Clinical Development team.
• Establish quality and compliance acceptability criteria in compliance with GCP regulations, guidelines, and standards for new clinical vendors.
• Oversee the evaluation of existing clinical vendors to assure continued compliance with GCP regulations, guidelines, and standards.
• Perform GCP vendor and investigator site audits per defined audit plans and communicates findings to management.
• Oversee the review of investigator site and clinical vendor audit reports (i.e., observations and ratings), if conducted by contract auditors, and communicates findings to management.

GCP Compliance

• Support development, Improvement and implementation of the GCP vendor management program and internal quality audit program.
• Oversee the analyses of audit program results, quality issues and investigations in order to optimize regional operations and global state of compliance. 
• Monitor and interpret compliance issues identified across clinical programs and elevates systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution.
• Act as a resource for revision of current and creation of new Clinical Operations SOPs.
• Collaborate with Quality Management and Quality Systems QA to identify and mitigate GCP quality and compliance issues with potential systemic impact.
• Provide appropriate risk analyses for key stakeholders to make critical decisions.
• Communicate the state of compliance to executive management by participating in a Quality Management Review program.
  

Regulatory Inspection / External Audit Support

• Participate/ Lead GCP-directed regulatory inspections and audits.
• Assure observation responses are timely and appropriate to maintain good standing with regulatory agencies and partners.
• Coach and educate external sites and cross functional Zymeworks staff in clinical regulatory inspection readiness activities.

What You'll Bring

• 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 QA experience or an equivalent combination of education and experience.
• A minimum of five (5) years of GCP auditing experience (Clinical Vendor audits and Investigator Site Audits).
• Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional team. Ability to establish and maintain effective working relationships.
• Advanced understanding of Quality principles, Regulations, Industry Standards and guidelines as relates to GCP and GLP regulatory requirements, Good Documentation Practices, and GXP quality review methodologies.
• Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a fast paced, challenging, milestone-driven environment.
• Proficiency with authoring and revising Policies, SOPs, Work Instructions and Form creation.
• Ability to work with CROs in a collaborative fashion to aid in advancement of Zymeworks therapeutics through different phases of development.  
• 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 and listening skills.
• Proficiency with MS Office, Veeva Document Management System, and ComplianceWire Learning Management System.
• Ability and willingness for up to 30% travel (domestic & international), consistent with the project needs.

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 base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. 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).

Our total rewards package that includes: 

• Industry leading vacation and paid time off
• Exceptional medical, dental and vision benefits by country
• Zymelife health and wellness benefits
• Matching RRSP / 401K / Pension program
• Employee Share Purchase Program
• Employee Equity Program
• Paid time off to volunteer in your community

This role is not eligible for relocation or immigration support. 

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.