Quality Assurance Manager
Search Cube
- Singapore
- Permanent
- Full-time
- Personnel Management: Hire, train, develop, and evaluate the performance of personnel in the QA Documentation and Training Area, maintaining an organizational structure that meets immediate and long-term objectives.
- Quality System Oversight: Own the Management Review process, ensuring the effectiveness of the quality system across Quality Documentation, Training, and Supplier Quality departments.
- Compliance and Strategy: Ensure adherence to AbbVie policies, contributing to strategy development and overseeing complex programs to maintain global regulatory compliance.
- Program Management: Lead broad, cross-functional quality initiatives and organizational changes related to the quality system, managing resources and prioritizing effectively.
- Training Program Management: Establish and maintain a CGMP training program, ensuring all personnel are adequately trained.
- Documentation Control: Oversee documentation control quality programs, including Document Change Control and Batch Record Archive.
- Supplier Quality Management: Administer and maintain supplier quality programs, including CAPA system oversight and Supplier Qualification.
- Cross-Functional Support: Support QC, Engineering, Quality Systems, and Operations to achieve site goals, participating in or chairing project team meetings.
- A Degree or Higher in Science or Engineering discipline, with a Quality or Regulatory Qualification being an advantage.
- At least 5 years of experience in a Quality or Project/Program Leadership role within a pharmaceutical or biopharmaceutical GxP environment.
- Strong communication skills and excellent knowledge of pharmaceutical regulatory requirements (GMP).
- Minimum of 2 years of leadership experience in project leadership or people management roles.
- Demonstrated capability as a change agent, innovative thinker, and proficiency in PMP software skills (e.g., MS Project, Mind Manager).
- Experience in managing diverse teams, with a strong problem-solving ability, independence, and meticulous attention to detail.