Manager QA, Third Party Manufacturing

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries

Manager QA, TPM

San Diego, Carlsbad, CA or Lake Forest, IL

DO WORK THAT MATTERS

The Rapid Diagnostics Division at Abbott is a part of our Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Manager QA, TPM is within our Cardiometabolic Business Unit and can be based out of our Carlsbad, San Diego, CA or Lake Forest, IL operations. This is a first of its kind role for our CM BU and will be fundamental in providing strategic and functional leadership of QA activities for global TPMs, ensuring compliance to applicable regulatory requirements and Quality Agreements and in co-operation with all relevant functions.

RESPONSIBILITIES

• Lead the quality related activities at a number of Third Party Manufacturer’s (TPM’s) producing global products on behalf of Abbott, to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements.
• Manage the assigned resources to ensure that TPM’s maintain compliance to applicable regulatory requirements and Quality Agreements.
• Ensure that the global TPMs and/or suppliers perform and document the appropriate engineering approach for activities such as qualification and validation and assist in these efforts, 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 global TPM to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.
• Direct the TPM 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 TPMs, 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 decisions 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.

QUALIFICATIONS

• Bachelor’s Degree in Engineering, preferably Manufacturing or Mechanical Engineering, and 7 years of related work experience (Operations Management and/or TPM Management) is required
• Experience with Root Cause Analysis is required
• Experience in Medical Device and/or Medical Diagnostics manufacturing industry required
• Quality Systems experience required
• Instrument manufacturing experience is preferred
• Strong communication skills required
• Demonstrated experience with data driven decision making skills is required
• Global Operation experience is desired
• Advanced knowledge of MS-Office
• Strong financial acumen