Senior Supplier Quality Manager
Job Summary
The Supplier Quality Manager performs a key function in the Quality relationship building QA oversight and issue resolution with suppliers/TPMs in support of AbbVies commercial and pipeline supply chains. The individual will work collaboratively across Technical Manufacturing Quality Product Support and Research and Development teams in direct support of supplier this role the supplier quality manager is the primary quality contact to specific strategic supplier partners. This individual will be responsible for assuring investigations CAPAs change management and audit readiness meet agency and Abbvie expectations. The individual will provide on site supplier support and upskilling to ensure the key suppliers are improving quality performance and ready for agency inspections.
- Build and maintain strong relationships with regional suppliers to support AbbVies pipeline and on market product portfolio.
- Assure authenticity of commercial and pipeline product supply chains by performing on-site visits with suppliers to verify business operations and potential areas of improvement.
- Conduct quality business reviews with identified suppliers to assure customer interface of necessary communication to support new product launches.
- Drive remediation efforts with suppliers including PAI readiness and issue resolution.
- Leverage technical expertise to assist in issue resolution at suppliers including investigation review and CAPA planning.
- Ensure all quality expectations related to suppliers in New Product Introductions (NPI) are met.
- Participate in process validation campaigns at Suppliers and provide validation overviews to Quality Business unit.
- Execute audit readiness and upskilling at suppliers in preparation to external and internal quality audits
- Coordinate remediation efforts when poor audit performance is identified at EU suppliers.
Qualifications :
- Bachelors degree preferably in Chemistry or Engineering
- 15 years of overall experience in Quality and or Manufacturing with specialist or supervisor experience
- Good problem solving and analytical skills
- Good verbal and written communication skills in English
- Good interpersonal relations / communications skills
- Knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing.
- Prior experience in analytical labs manufacturing environment and managing supplier compliance desired.
- Able to travel up to 30 50 % of the time.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more