Quality Computer Systems Manager
Quality Computer Systems Manager
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.
Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company. This position will be based in Seattle and will report to the Director, Quality Assurance.
• Acts as Quality department lead on the management, design, development, implementation and technical support of Quality Management, Document Management and Learning Management electronic systems.
• Leads deployment and management of systems and related integrated processes to support the overall digital / IT Quality compliance systems landscape.
• Acts as the primary Quality department interface with IT in support of Zymeworks Quality electronic systems including system configuration changes, updates, expansions and validation.
• Manages the existing Electronic Document Management System (Veeva) user configuration and workflows for GXP documentation and controlled procedures, corporate policies and procedures, and regulatory submissions.
• Manages Veeva document life-cycles including, but not limited to, creating templates, reviewing, revising and approving GXP documentation.
• Provides training and support to end users on use of the Quality electronic systems.
• Establishes and maintains procedures, policies and systems required to meet biotechnology/pharmaceutical regulations and expectations for Quality electronic systems.
• Supports GXP document management of hard copy documentation including archival, retention and/or destruction as per regulations and internal quality procedures.
• Supports management of incoming external documentation from Contract Research and Manufacturing Organizations (CROs and CMOs) including master batch files, executed batch files, raw data, method validation protocols and reports, stability and release testing data, study protocols and reports, specifications, and other controlled documents, as required.
• Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Experience:
• Bachelor 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.
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
• 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 systems 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 preferred
• Performance driven with an understanding of how to work collaboratively with cross-functional teams
• Experience with Computer System Validation, preferred
• Proficiency with MS Office
• Positive, enthusiastic and customer service oriented
• Excellent editing, grammar and proofreading skills
• Experience with Veeva platform a plus
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.