Senior Manager* QA (QA Compliance)
BioNTech
- Singapore
- Permanent
- Full-time
- Responsible to lead and direct the assigned Quality Process
- Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
- Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations
- Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
- Owns policies and procedures of the assigned Quality Process where applicable.
- Partners with global and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
- Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
- Ensures deviations from assigned Quality Process are documented and investigated
- Ensures QA personnel are qualified and trained to perform assigned tasks
- Support technology transfer activities.
- Develops strategies for assigned Quality Process to be fit for purpose, site operation readiness, including continuous improvements and ensure a state of inspection readiness
- Leads inspection and audit preparations
- Lead/ coordinates the relevant forums/activities of the assigned Quality process (e.g. Quality Management Review, Quality Risk Review, APQR)
- Escalates quality and compliance risks to Head of Department, QA
- Supports improvement initiatives, programs and projects of the assigned Quality Process
- Build, maintain and develop a team to support the deliverables of this assigned Quality Process
- University degree/Advanced Degree in Science (medicine, pharmacy, chemistry, biotechnology, biology or equivalent).
- At least 12 years' professional working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry with
- Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing
- Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
- High degree of conscientiousness and diligence
- Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
- Self-starter and learning capacity
- Sense of ownership and honesty (proactive handling of errors)
- Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment
- Expectation to be hands on, interactive and display practical leadership
- Good communication skills
- Fluent in written and verbal English
- Only applications sent via our online form shall be considered.
- Only Candidates with the right qualifications and relevant experience shall be shortlisted and
- Incomplete applications shall be rejected.
- BioNTech will run a background check during the hiring process