Department: Quality Assurance
Reports To: Senior Director, Quality Management Systems
Education Required: Bachelor’s degree or higher, preferably in Science
Hours: 40 hours/week
Over-time may be required on occasion
Hours: 40 hours/week
Over-time may be required on occasion
The Senior Manager or Associate Director of Inspection Management will be based in San Mateo or Emeryville, CA. This will be a hands-on position that will be responsible for the organization, planning, process and logistics of all health authority inspections. This will include, but not limited to, inspection readiness activities, inspection management training, developing and maintaining BeiGene’s inspection management process and development of inspection management tools and systems.
Essential Functions of the job:
- Build a robust inspection management process and cohesive inspection support teams to support the organization and execution of all health authority inspection related activities
- Provide a risk assessment of company’s level of inspection readiness
- Lead all inspection readiness meetings, attend functional department meetings and Study Management Team meetings to ensure inspection readiness activities and expectations are communicated in a timely manner
- Lead all communications and inspection preparation training for vendors and sites
- Provide expeditious inspection updates/daily summaries to Executive and Senior Management which include: inspection findings, near misses, Health Authority responses, commitments and appropriate mitigation activities
- Develop a Managing Regulatory Inspections training program for the company and provide training on a periodic and as-needed basis
- Ensure follow-up on all inspection commitments, responses, post-inspection activities, corrective and preventative actions, and resolve all conflicts for timely closure
- Participate in GCP site and vendor audits in accordance with BeiGene standard operating procedures, quality policies and/or plans
- Create a central repository of all global/local regulatory inspection requirements and practices
- Escalate all compliance issues appropriately in timely manner
- Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- Expert knowledge of regulatory authority inspection practices internally, externally, domestic and internationally
- Extensive experience managing and supporting regulatory authority inspections of clinical research activities
- Extensive leadership experience and mentoring skills to ensure all BeiGene team members have a firm understanding of BeiGene inspection process
- Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines
- Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials
- Strong working knowledge of clinical development and operations
- Ability to plan, multi-task and manage time effectively
- Strong writing and record keeping ability for reports and training manuals
Communication & Interpersonal Skills
- Excellent verbal, written communication and presentation skills
- Experience in providing training on key quality and regulatory compliance information
- Strong Partnering and collaboration skills
- Balanced approach to issue management and mitigation planning
- Ability to effectively collaborate in a dynamic environment
- Clinical Operations
- Clinical Business Operations
- Supply Chain/PharmOps
- Medical Monitors
Desired Background and Experience
- Clinical Quality System and Clinical computerized systems; e.g., EDC, IxRS, etc.
- Knowledge of global and local GCP regulations
- Global Regulatory Inspection Management
- Provide managerial support to one or more contingent workers with overall responsibility of leading, training, and mentoring for effective performance.
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.
- 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
- 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