Global TPM/Supplier QA Product Manager
3 weken geleden
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
The Global TPM/Supplier QA Product Manager is responsible for providing QA general support for assigned TPM’s and Suppliers and associated quality systems to ensure that safe, efficacious and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.
You will manage the quality related activities at a number of Third Party Manufacturer’s (TPM’s) and Suppliers ensuring effective Quality and Compliance oversight to marketed global/ multiregional products for the Established Pharmaceuticals Division of Abbott, to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements.
Major Duties and Responsibilities:
Manage TPM’s and Suppliers as assigned from a Quality perspective.
Provide support of global quality and compliance strategy for assigned commercialized products with global/multiregional scope.
Serves as product quality and compliance resource during planning and execution of major changes for assigned commercialized global products.
Co-ordinate the change control program for changes impacting products manufactured at assigned TPMs and Suppliers.
Prepare Quality/Technical Agreements to align with the legal contracts.
Support a program/project management process to support quality and compliance initiatives at TPMs.
Participate on QA cross-functional teams to support TPMs and Suppliers , as necessary.
Travel to off-site locations to ensure and aid the quality infrastructure and appropriate quality systems for alignment to QA Supplier or Third Party Manufacturing Quality or Technical Agreements.
Support the management of critical exception documents and CAPA. May act as the primary quality review and decisions maker for relevant TPM and Supplier exception documents for impact on product quality, safety, efficacy and impact to the regulatory filing.
Ensure the appropriate GMP requirements are met for the validation of the product, process, equipment and facility. Be the final approver of these documents.
Coordinate and approval activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
Prepare, review and approve Annual Product Quality Reports to ensure accuracy, completeness, timeliness, and those trends are identified and addressed in an appropriate manner.
Support the TPM and Supplier QA management and approval of exceptions documents and CAPA’s elevated by Suppliers and TPMs and ensure that where appropriate senior Quality management are notified.
For assigned TPMs and Suppliers, complete quality review meetings that identify and address quality, operational, and organizational issues.
Support TPM/Supplier Quality Heads in providing quality and compliance support/advice for drug substance manufacturing at API suppliers and finished dosage form product manufacturing, packaging, and labelling to the TPMs.
Support the pre-approval inspection readiness at TPM to ensure regulatory approvals are obtained, with no delays to market entries.
Education and Background:
A 3rd level degree in a relevant Quality or technical/scientific discipline.
Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with 5- 8 years in QA, Operations, or Technical Support in a pharmaceutical setting.
Manufacturing related experience in some of the following areas: sterile, liquid, solids or API’s.
Audit 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.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
How do you apply?
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