Abbott Sr Manager TPM and Supplier QA in Abbott Park, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Provide strategic and functional leadership of QA activities for TPM and suppliers ensuring compliance to applicable regulatory requirements and Quality Agreements and in co-operation with all relevant functions. Manage a staff of Supplier Quality Engineers to support the supplier management program at TPM. Ensure that the TPM and suppliers perform and document the appropriate engineering approach for activities such as qualification and validation of processes, methods, and equipment, and assist in these efforts, as appropriate. Lead the quality related activities at Third Party Manufacturer (TPM) and suppliers producing global products on behalf of Abbott, to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements.
• Monitors supplier performance and reports supplier quality trend data to upper management. Supports supplier continuous improvement plans and activities.
• Serves as a Subject Matter Expert during Internal and External inspections.
• Establish and maintain successful cross-functional relations with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, and Quality Systems departments. Manages Supplier Quality budget.
• Responsible for assuring the development of the Supplier Quality Engineering staff, providing growth plans and professional guidance, as appropriate.
• Evaluate and approve supplier requested changes or improvements. This activity may include changes such as the identification and/or approval of a new supplier to provide an alternate material, site change, and manufacturing process changes.
• Develop and consistently execute a quality strategy for TPM /Suppliers to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.
• Direct the TPM/Supplier QA team to ensure that the commitments of the Quality Agreements are being fulfilled and help facilitate resolution in cases where they are not.
• Develop and Lead goals with cross-functional/global scope.
• Lead and participate on QA cross-functional teams to support TPM and suppliers, including active participation in Business Management Reviews as necessary.
• Support long-range planning efforts for capacity (people, systems).
• Act as the primary quality review and decision maker for high impact TPM exception documents for impact on product quality, safety, efficacy and impact to the regulatory filing.
• Provide a Quality Assurance service with regards to guidance on validation strategies; guidance on product, process, equipment, analytical which may or may not require a re-validation.
• Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for TPMs and Suppliers, that identify and address quality, operational, and organizational issues.
• Promote continuous improvement, innovation, simplification aligned with Abbott and division strategy.
Bachelor’s Degree; preferably in the life or physical science or engineering Bioengineering or other science disciplines 10 years of experience in Supplier related functions. A minimum of 4 years’ experience in Quality Assurance/Regulatory in company with medically focused manufacturing environment. Minimum of 6 years in management of direct resources or cross functional teams. Working knowledge of regulations and standards affecting Medical Device manufacturing (e.g. QSR, ISO, EN Quality System Requirements).
Demonstrated experience with development, implementation and management of company-wide quality system procedures/practices.
Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects, influence internal and external groups and provide leadership from a quality perspective.
Highly developed written, oral and interpersonal skills, strong statistical application experience and proficient use of various software applications such as MS Word, Excel, Access and statistical analysis tools.
The incumbent should have a proven record of leadership with strong organizational and human relations skills. This includes the ability to deal with multidisciplinary functional areas within the division and the site.
Knowledge of Design Control, V&V operations and manufacturing practices is desirable. CQE, CQA, CQM via ASQ preferred.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org