We are seeking an enthusiastic and highly motivated Director/Senior Director, Quality Assurance to join the Quality group. The successful candidate will be responsible for: helping to define, communicate and implement the company’s quality strategy and vision.
Key Responsibilities Include:
- Provide strategic and proactive QA leadership in alignment with Global Head of Regulatory Affairs & QA
- Responsible for the operational management of local Quality Management System (QMS) covering GCP and/or GMP activities of a biotech company in alignment with corporate QMS.
- Manage and oversee the local QMS e.g.
- SOP system
- Training system
- Audit system covering GCP & GMP audits
- Batch disposition, recall, and field alert system
- Risk Management system
- Provide guidance, interpretation, support, training, and key input to relevant stakeholders in the company for consultation and interpretation of regulations, guidelines, corporate standards, and SOPs
- Development of employees (as the role grows)
- Provide input to budget planning and oversee budget for your area of responsibility
- Ensure inspection readiness
- Bachelor’s Degree or above in a Science/Engineering or related field.
- 10 years’ experience preferred in the pharmaceutical/biotech industry and in QA, including direct experience in a GxP environment
- At least 5 years of demonstrated leadership experience in leading QA professionals
- Experience in performing audits of GMP and/or GCP areas highly desirable
- Experience in setting up quality system in GMP and/or GCP area
- Detailed knowledge of cGMP and GCP regulations (such as 21CFR part 210, 211, 312, 314 etc.) and guidelines (e.g. ICH GCP)
- Independent self-starter is a must
Approximately 10-20% of this position will require travel.