Updated 28 days ago

Manager / Administrator, Digital Inspection Management System & Logistics

Emeryville, CA 94608
Full-time, Part-time
Location: Emeryville

BeiGene 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.

Position Summary:

This will be a hands-on position that will be responsible for the administration of BeiGene's digital Inspection Management System and manage the logistics of technology related setups/administrations. In collaboration with respective GxP GQA team, provide organization, planning, process, and logistics for BeiGene hosted internal, regulatory and partner audits and inspections. This will include, but not limited to digital inspection management system training, improvement of BeiGene's digital inspection management process and maintenance & enhancement of inspection management tools and systems.

Essential Functions of the Job:

  • Build a robust digital inspection management system/processes to support the execution of all health authority inspection related activities.
  • Proactively administer BeiGene's digital Inspection Management System.
  • Proactively provide trainings and is SME for the digital Inspection Management System.
  • Support to ensure the digital Inspection Management System is adopted at all BeiGene sites and functional areas.
  • Proactively ensure all audit/inspection physical logistics are properly setup in a timely manner such as scheduling inspection rooms, war rooms, equipment, IT/admin support etc.
  • Facilitate post audit/inspection lessons learned sessions.
  • Evaluate and implement digital system and process improvements from lessons learned feedback.
  • Train, administer and troubleshoot of extranet/intranet ensuring internal/external users have successful access.
  • Escalate all compliance issues appropriately in timely manner.
  • Other duties as assigned

Supervisory Responsibilities:

May have supervisory responsibilities to provide support to workers with overall responsibility of leading, training, and mentoring for effective performance.

Qualifications:

  • 6-10 years of experience in the pharmaceutical/biotechnology industry
  • 5+ years of regulatory compliance experience and managing regulatory inspections in one of the following areas: GCP, GLP, GMP
  •  RQAP-GCP or other certifications are highly desirable

Supervisory Responsibilities: Provide managerial support to one or more contingent workers with overall responsibility of leading, training, and mentoring for effective performance.

Education Required: Bachelor's degree in science or combination of education and equivalent work experience

Computer Skills:

  • Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Inspection Management Systems
  • Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
  • Ability to work on a computer for extended periods of time.
  • Regularly required to sit for long periods of time, and occasionally stand and walk.
  • Regularly required to use hands to operate computer and other office equipment.
  • Close vision required for computer

Travel for Work: As Required

Competencies:

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 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 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 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 within budget.

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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 law. All employment is decided on the basis of qualifications, merit, and business need.

Posting ID: 625557863Posted: 2021-05-29Job Title: Manager Administrator Digital Inspection Management