Senior Manager, Systems Validation

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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,  us.recruiting@beonemed.com.

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Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $134,800.00 - $179,800.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Visio