Zymeworks is a 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.
Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company. The Sr. Manager of Clinical and Quality Applications will lead the newly formed functional area and will be initially responsible for hand-on management of the technology applications supporting our Clinical and Quality business units. As the needs of these business units evolve; the role will eventually transition to more people management and strategy.
This individual is a strategist, collaborator, and confident leader that understands the complexities of the application and regulatory requirements for Clinical and Quality. This person is passionate about driving and delivering meaningful changes to support our current and future goals.
The position requires a solid understanding of Clinical and Quality operations and extensive hands-on expertise in specific technologies (e.g. Veeva QMS/RIM), excellent business analysis and project management skills.
This position will report to the Director, Information Technology and will be based in Seattle, WA.
- Partners with peers and business stakeholders to develop strategic roadmap for electronic application platforms supporting the Clinical and Quality business functions.
- Deploys, Manages and Configures Clinical and Quality applications, as needed, to meet business needs.
- Provides leadership and subject matter expertise on Clinical and Quality application projects to ensure successful delivery outcomes.
- Identifies and partners with external service providers to deliver solutions and services.
- Responsible for developing, interpreting, reviewing, validating, documenting and maintaining functional requirements.
- Recruits, supervises and trains staff. Plans, schedules, allocates and prioritizes workload to meet operating requirements and evaluates performance ensuring requirements are met.
- Ensures team members understand departmental objectives, specifications, deliverables, timelines and tasks.
- Monitor, assess, and ensure compliance of Clinical and Quality Applications with internal IT general controls and external regulatory requirements.
- Develops and implements policies, procedures and guidelines to ensure the quality of data and effective use of Quality and Clinical applications.
- Coordinates GXP system validation, where applicable, and maintains requisite documentation.
- Maintains an awareness of new technologies, trends and developments in order to improve service and create efficiencies within the department. Keeps up-to-date with relevant professional literature and participates in seminars and training workshops as required.
Qualifications and Experience
- A minimum of 5 years of related work experience managing clinical and/or quality applications in a commercial-stage pharmaceutical company.
- Bachelor’s degree (scientific, business or technical degree) or equivalent experience
- Experience working as a liaison between IT and regulated business units in a pharmaceutical company
- Experience with Risk Assessment
- Experience with electronic applications used in clinical trials such as (EDC) IRT, Clinical Supply Chain, eTMF, CTMS).
- Experience with electronic applications used for Quality Systems such as QMS,
- Experience with user requirements analysis and system implementation.
- Experience with Software Development Life Cycle (SDLC) and Computer System Validation (planning, overseeing, executing, documenting)
- Experience and understanding of regulatory and compliance needs related to clinical systems such as 21 CFR Part 11, ICH GCP guidance, GDPR, etc.
- Veeva certification an asset
Why Work for Us?
At Zymeworks, we stand for innovation, integrity, collaboration and care.
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 https://zymeworks.bamboohr.com/jobs/.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging opportunity, please apply online at https://zymeworks.bamboohr.com/jobs/view.php?id=364. Due to the high volume of applicants, only those selected for interviews will be contacted.
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.Apply Now