Primary Job FunctionÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â

The TPM & Supplier QA Manager is responsible for Providing QA general support for assigned TPMâ€™s and/or Suppliers management and QA due diligence for Licensing and Acquisition playbook deal Â to ensure that safe, efficacious and quality product can be supplied to APAC region to meet cGMP and other applicable regulatory standards and the appropriate market requirements.Â

Core Job Responsibilities

Â·Manage TPMâ€™s and/or Suppliers as assigned from a Quality perspective.

Â·QA due diligence for Licensing and Acquisition playbook deal including:

Perform due diligence audits for new playbook deals through on-site audits/ desk top audits for all APAC/China regional product in-licensing, acquisition deal and/or distribution deals if applicable.
Compile the DD audit reports/elevation slides to summarize the risks associated with potential partners

Manage all Quality System activities associated with the role, including:
- Develop and maintain Quality/Technical Agreements to align with legal contracts and regulatory requirements.
- Management of high impact exception events and CAPA ensuring events are appropriately assessed for impact to Company and documented.
- Review and approval of TPM Product Quality Reviews to ensure accuracy and completeness and management of actions to address and identified trends.
- Review and approval of complaints arising from TPM/Supplier manufactured product and follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
- Management of all changes at TPMs/Suppliers which have a quality or regulatory impact, ensuring timely communication & implementation of changes in line with regulatory requirements.
- Approve and maintain the approved supplier list.
- Maintain a Quality Management Review program and Quality Performance Measurement for TPMs/Suppliers, 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 or Workstreams, as necessary.
- Visit TPMs/ and/or supplier locations routinely to build and maintain expertise with products and manufacturing processes building a close working relation with the TPM and/or supplier
- Provide support to management through the Significant Event and Management Review process to ensure relevant information is provided for events impacting assigned TPMs/Suppliers.
- Support a program/project management process to support quality and compliance initiatives at TPMs and/or Suppliers.
- Provide support to quality audits, initial site approvals.
- To perform projects and tasks as assigned

Supervisory/Management Responsibilities

Individual contributor

Position Accountability / Scope

The position is responsible and accountable for

Responsible for ensuring that TPMâ€™s and/or suppliers 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 and maintained.
Responsible for QA Due diligence for L&A playbook deal as per guidance from Supplier, TPM, L&A QA Director

Minimum Education

Bachelor 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/ Knowledge Required

Total combined years: 7+ in QA, Operations or Pharmaceutical engineering
Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations
Knowledge of international and local quality system and compliance legislations and standards
Leadership experience

","industry":"Healthcare","title":"TPM QA ManagerDivision: EPD Established Pharma
Travel: Not specified
Medical Surveillance: Not Applicable
Significant Work Activities: Not Applicable