• Senior Manager, Systems Validation

    BeOne Medicines (San Carlos, CA)


    BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Senior Manager, Systems Validation in San Carlos, CA:

    Job Duties:

    Manage the entire GxP change control process from initiation to closure to meet the requirements from project stakeholders. This includes global GxP systems that is used across Americas, APAC, China, EU, etc. Work closely with IT enterprise applications team, business process owners and key users to gather and documents user requirements from business stakeholders to establish intended use of computerized systems. Collaborate with project stakeholders to author validation deliverables (e.g. IQ, Validation Plan, Test Plan, Test Scripts, etc.) and revise accordingly based on guidance and feedback from Quality team. Manage validation activities of cross functional teams to ensure validation effort is executed to plan and properly documented in the appropriate validation documents. Support resolution and documentation of protocol and test discrepancies. Ensure validated systems remain in compliance with applicable regulations and internal procedures as changes to the systems are made. Help maintain post go live activities such as managing user onboarding documentation, revision release notes assessment for validation impact, assist with quarterly system access review documentation, etc. Maintain computerized system validation documentation. Telecommuting is an option.

    Minimum Requirements:

    Master’s degree (or its foreign degree equivalent) in Biotechnology, Engineering (any field), or a related quantitative discipline, and 6 years of experience in the job offered or in any occupation in related field, OR

     

    Bachelor’s degree (or its foreign degree equivalent) in Biotechnology, Engineering (any field), or a related quantitative discipline, and 8 years of progressively responsible experience in the job offered or in any occupation in related field.

    Special Skill Requirements:

    (1) software development lifecycle (SDLC); (2) working with IT Operations for business users in the pharmaceutical or life science industries; (3) Veeva Vault; (4) SAS, WinNonlin, VerifyPlatform, DocuSign, Medidata and Oracle CTMS; (5) Authoring and testing computer system validation deliverables in accordance with 21 CFR Part 11, 210 & 211, GLP, GCP, cGMP (current Good Manufacturing Practice) regulations. Any suitable combination of education, training and/or experience is acceptable. Telecommuting is an option.

     

    Disregard the below range, the selected candidate will earn a wage of $180,700.00 - $203,500.00 per annum.

     

    Submit resume with references to: Req.#: 24-150828 at: ATTN: Amy Nobriga, [email protected] .

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    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.