TPM QA Director
Abbott Laboratories · Shanghai
Core Job Responsibilities:
· Responsible for quality management of a number of Divisional TPMs.
· Accountable for quality oversight of the TPMs, including:
- Supporting product registration and market launch activities.
- Leading the TPM Due Diligence, onboarding process and establishing a governance model.
- Supporting Technology transfer activities as Technology Transfer Quality SME
· Responsible for TPM Quality activities, including but not limited to:
- Manage all Quality System activities associated with the role, including:
- Develop and maintain Quality/Technical Agreements to align with legal contracts and regulatory requirements.
- Responsible for managing highly complex TPMs
- Management of high impact exception events and CAPA ensuring events are appropriately assessed for impact to Abbott and documented.
- Review and approval of TPM Product Quality Reviews to ensure accuracy and completeness and management of actions to address any identified trends.
- Review and approval of complaints arising from TPM manufactured product and follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
- Management of all changes at TPMs which have a quality or regulatory impact, ensuring timely communication & implementation of changes in line with regulatory requirements.
- Maintain a Quality Management Review program and Quality Performance Measurement for TPMs that identify and address quality, operational, and organizational issues.
- Participate on QA cross-functional teams to support TPMs, including active participation in Business Management Reviews, as necessary.
- Visit TPMs locations routinely to build and maintain expertise with products and manufacturing processes building a close working relation with the TPM
- Provide support to Abbott Senior Management through the Significant Event and Management Review process to ensure relevant information is provided for events impacting assigned TPM.
- Supporting TPMs in audit and inspection readiness.
· Managing direct reports.
· Acting as the Single Point of Contact (SPoC) for the cross-regional TPM Quality Platform and contributing to cross-regional initiatives and goals.
· Representing the TPM QA group in multi-functional divisional initiatives and projects, such as continuous improvement and quality systems associated projects.
· Providing quality support for Technology Transfer Projects, ensuring compliance with all relevant quality requirements throughout the transfer process.
· Responsible to maintain successful Quality Metrics and support team to achieve it
· Support NPI (New Product Introduction) Process and lead quality related activities
Position Accountability/Scope:
This position is responsible and accountable for:
- Responsible for ensuring that TPM maintain compliance with the Quality Agreements and local and international regulations as required by markets supplied and ensuring that the quality systems are appropriate so that the product safety, efficacy and quality are maintained.
- Within the accountability and scope of this role, all the Core Job responsibility associated with product quality assurance & compliance of commercialized product from assigned TPMs.
- Supervision of direct reports/ non-reported team members through regular meetings and oversight of activities.
Minimum Education: Bachelor's degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries.
Minimum Experience/Training Required:
- Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with minimum 15 years in QA, QC, Operations, or Technical Support in a pharmaceutical setting.
- Manufacturing related experience in some of the following areas: sterile, liquid, solids or API’s.
- Audit or supplier quality management experience of suppliers in pharmaceutical industry
- Troubleshooting and issues resolution skills.
- Project management expertise.
- Perceptual and analytical problem solving related to removal of obstacles, setting priorities, people, resources and facilities involvement.
- Ability to communicate effectively, both orally and in writing to both internal and external audience.
- Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives.
- Ability to use Quality Risk Management tools.
- Capable of analyzing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
- Experience leading and managing teams
- undefined