Reports To: Sr. Director GMP QA OSD and Biologics
Education Required: Bachelor of Science degree, in a related scientific discipline
Hours: 40 hours/week
Over-time may be required on occasion
The Director, GMP QA OSDOSD is responsible for overseeing quality operational activities and programs related to OSD manufacturing. Develops, interprets, and implements quality policies and supports regulatory compliance inspections. Manages OSD QA compliance activities to support GMP manufacturing, testing and release of finished OSD products under FDA regulations, applicable international regulations, ICH standards, and internal procedures.
Essential Functions of the job:
- Supports development and management of the OSD QA program, systems, policies, procedures and controls to ensure that BeiGene OSD products conform to established standards and regulatory agency requirements
- Work with CMO and internal staff to ensure manufacturing processes remain in a compliant state, product meets all required standards and specifications
- Work with CMOs to put Quality Agreements in place, ensure quality standards are met, issues are resolved promptly and effectively
- Manage the external audit program for OSD
- Manage documentation, reporting and closure of compliance issues
- Conduct trend analysis of audit results, investigations, corrective actions, provide management with root cause analysis in annual quality system performance report
- Review GMP quality metrics. Analyze data relating to manufacturing process controls, and continuous process improvement efforts. Coordinate the necessary quality adjustments
- Review relevant GMP documents for compliance to company SOPs, quality systems and regulatory requirements
- Oversee the following investigations: nonconforming product, customer complaint, laboratory OOS and CAPA. Ensure all investigations are performed and closed in timely fashion
- Perform quality system performance review process for GMP related metrics as it relates to OSD Products
- Manage GMP training initiatives
- Support Annual Product Review for OSD Products
Core Competencies, Knowledge and Skill Requirements
- Working knowledge of GMP regulations and experience with regulatory compliance inspections
- Working Knowledge and experience with 21CFR210, 21CFR211, ICHQ7 as well as international regulations
- Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems
- Ability to effectively lead teams and manage staff
- Must possess strong presentation skills to speak effectively before groups; ability to respond
Communication & Interpersonal Skills
- Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail
- Interacts with all levels of BeiGene employees; CMOs
- 15+ years of experience in the pharmaceutical/biotechnology industry
- 10+ years of GMP QA experience, 5 of which includes management experience
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)
- Must be willing to travel approximately 25%
- Ability to work on a computer for extended periods of time