Computer System Validation Manager
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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 a highly-motivated professional who is looking to grow their career with our company. This position will report to the Director, Quality Assurance and will be based in Seattle, WA.
- Ensures Zymeworks’ systems are compliant with regulations, including FDA, EU Annex 11, and other IT related compliance regulations.
- Establishes Zymeworks’ Computer System Validation system including writing SOPs, Policies, and processes.
- Keeps abreast of the evolving regulatory policy and industry best practices related to regulated software and IT Systems.
- Translates computerized system specifications into executable validation protocols.
- Identifies, diagnoses and resolves computer system related quality problems.
- Identifies computerized system compliance gaps and trends and develops and executes strategies to close gaps in an efficient, technical, and compliant manner.
- Participates in the development, implementation, and maintenance of the quality management system (QMS).
- Creates, maintains and enforces companywide computer system compliance policies and procedures.
- Reviews and evaluates off-the-shelf software, software development tools and software systems used in quality related processes to determine appropriate validation requirements.
- Provides QA input to author, review and finalize CSV related documentation.
- Provides CSV oversight and approval of IT system and platform risk assessments.
- Collaborates with functional areas to establish and update metrics that are reported to leadership that highlight risks and key opportunities for continuous quality improvement.
- Facilitates effective cross-functional communication, alignment, collaboration and execution on IT and software quality-related objectives, plans, and priorities.
- Partners with IT to implement and maintain software systems in a compliant manner.
- Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Experience
- Bachelor of Science degree or equivalent in science, technology or another relevant academic discipline and a minimum of 5 to 7 years hands-on experience implementing and maintaining technology to support QA compliance or an equivalent combination of education and experience.
- Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional team. Ability to establish and maintain effective working relationships.
- Experience in developing or reviewing system Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceability matrices and Validation Summary Reports.
- Good organizational skills and the ability to work effectively in a high paced, fast changing environment. Results-oriented with the ability to prioritize.
- Experience with computer system validation practices (GAMP) and 21 CFR Part 11 regulations.
- Demonstrated understanding of industry technology trends in quality, document and learning. Management.
- Experience managing electronic document management systems.
- Experience with Veeva Vault, a cloud-based content management system a plus.
- Performance driven with an understanding of how to work collaboratively with cross-functional teams.
- Demonstrated experience with Computer System Validation.
- Proficiency with MS Office.
- Positive, enthusiastic and customer service oriented.
- Excellent editing, grammar and proofreading skills.
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.