Job details
Job type full-time
Full job description
Beigene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionalsWhen considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancerPosition summary: srManager of computer systems validation qa will oversee the gxp computerized systems validation and provide qa oversight within beigeneThe individual ensures that gxp systems meet intended uses and comply with applicable regulations, current industry practices, and beigene’s proceduresEssential functions of the job:
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 in veeva platform.
Provide training on validation related topics.
Review computerized system related sops to ensure beigene’s practices meet relevant regulations and follow industry best-practices.
Supervisory responsibilities: this position may include managing staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when requiredQualifications:
Experience in gxp regulated industry
10+ years of industry experience
4+ years of computer-related or software validation experience
Familiarity with gxp regulations and approaches to system development life cycles (sdlc) and gamp
Experience validating saas systems a plus
Education required: bachelor’s degree in life sciences, computer sciences, or a related field computer skills: efficient in microsoft word, excel, and outlook travel for work: may require up to 20% travelCompetencies: ethics - treats people with respect; inspires the trust of others; works with integrity and ethically in accordance with beigene’s code of business conduct and ethics, policies and procedures.
Planning/organizing - prioritizes and plans work activities; uses time efficiently; completes administrative tasks correctly and on time; follows instructions and responds to management directionCommunication - 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 informationTeamwork - 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 othersAdaptability – 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 eventsTechnical skills - assesses own strengths and development areas; pursues training and opportunities for growth; strives to continuously build knowledge and skills; shares expertise with othersDependability - follows instructions and 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 qualityAnalytical - synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement dataProblem solving - identifies and resolves problems in a timely manner; gathers and analyzes information skillfullyProject management - communicates changes and progress; completes projects on time and within budgetWe are proud to be an equal opportunity employer and we value diversityBeigene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate lawAll employment is decided on the basis of qualifications, merit, and business need.
