Bachelor’s degree in life sciences, computer sciences, or a related field
Manager/Sr. Manager of Computer Systems Validation QA will oversee the GxP computerized systems validation and provide QA oversight within BeiGene. The individual ensures that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and BeiGene’s procedures.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Work closely with the Business Process Owners and IT to ensure deployment of GxP systems meets BeiGene’s standards, relevant regulations, such as 21 CFR Part 11 and Annex 11 and systems are maintained in a validated state.
- Provide QA and compliance support and strategic direction for validation activities by:
- Participating in system implementation project teams
- Ensuring adherence to BeiGene’s standards during the execution of the validation activities
- Assisting with issue resolution and provide strategic direction for documentation
- Assisting with the development of system specific validation plans and strategy
- Reviewing/approving the validation deliverables
- Author/review Computerized System related Incident Reports, Investigations, Root Cause Analysis, and CAPAs
- Support the management of computerized system vendors
- Support Annex 11/21 CFR Part 11 Inspection Readiness
- Provide training on validation related topics
- Review Computerized System related SOPs to ensure BeiGene’s practices meet relevant regulations and follow industry best-practices.
This position may include managing staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when required.
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills: Efficient in Microsoft Word, Excel, and Outlook
- Experience in GxP regulated industry
- 8+ years of computer-related or software validation experience with at least 4 years in quality assurance role
- Familiarity with GxP regulations and approaches to System Development Life Cycles (SDLC) and GAMP
- Experience validating SaaS systems a plus
Travel: May require up to 20% travel