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- At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to workin the U.S. without Abbott sponsorship.
Lead the CAPA and CAPA metrics programs in a manner compliant with 21 CFR Part 820 & part 11 regulations and ISO13485.
Directly supervise a team of CAPA Investigators and CAPA analysts and lead an extended team of qualified investigators with members from multiple functional areas across the site/division in the performance of investigations for multiple product lines and systems deemed critical to the success and financial performance of the Division. Establishes Training material for members of the CAPA program and ensures training strategies maximize performance and compliance with worldwide regulatory requirements & expectations. Ensures the execution of the Executive Management Review Program and that appropriate metrics are identified, compiled, and reviewed. Division Liaison to the Corporate Quality organization in the maintenance of the Global System for Exception Reporting and CAPA and for the Quality Systems Data Warehouse (QSDW).
Establishes and drives strategies to achieve site and division quality and compliance goals with regards to the CAPA investigations and the CAPA metrics program.
This includes the establishment of Quality System policies and procedures as needed to ensure compliance.
Directly supervises a team of CAPA Investigators and CAPA analysts and leads an extended team of qualified investigators with members from multiple functional areas across the site/division in the performance of non-conformance investigations and corrective actions.
Reviews CAPA investigations performed by qualified staff to ensure that documents are thorough, complete and timely.
Manage the resolution confirmation process & works with event owners and division management to ensure CAPA quality, timeliness and other compliance parameters.
Establishes Training material and approaches for members of the CAPA program and ensures training strategies maximize performance and compliance with worldwide regulatory requirements & expectations.
Leads the CAPA Review Board (CRB) process; executes Quality signatory authority for the review and disposition of non-conforming product in accordance with regulatory requirements.
Verifies product safety and efficacy have been evaluated and issues related to safety/patient results are elevated for risk evaluation.
Ensures the execution of the Executive Management Review Program and that appropriate metrics are identified, compiled, and reviewed by a cross-functional team in order to identify adverse trends and the drivers for those trends.
Division Liaison to the Corporate Quality organization in the maintenance of the global system for Exception reporting and CAPA and for the Quality Systems Data Warehouse (QSDW).
Works closely with Sr. management and colleagues across the division to ensure the CAPA department provides a responsive, efficient and effective service to customers.
Authorizes changes to CAPA Management Systems.
Serves as the primary CAPA system contact during regulatory inspections and Corporate AQR audits.
Identify and recruit staff and resources to support the CAPA program.
Develop, maintain and manage the department budget and related goals for the CAPA program.
Influence and visibility extend beyond immediate organization, including international sites, ADC & Corporate Executive Management and Divisional Management across Abbott.
Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, quality and regulatory.
Compliance activities are of the utmost importance to our business.
The CAPA System is a key inspection focus of worldwide regulators and auditors.
The system must be usable, simple, sustainable and well maintained; Failure to comply with the primary objectives of this role will result in negative impact to the business such as observations, warning letters, de-certification, or product recall.
Bachelor’s Degree or equivalent education or 5 years equivalent experience in a regulated environment to be able to understand complex processes.
Good working knowledge of regulations and standards affecting IVDs and Medical Devices. Minimum 5 years related experience in a quality discipline, CAPA preferred. Minimum 5 years’ management experience.
Strong Problem Solving Skills. Experienced in effective verbal and written communications. Excellent interpersonal skills. Ability to communicate effectively across all levels of the organization. Computer literate with excellent knowledge of databases, spreadsheet and word processing. Project Management experience is preferred in order to effectively manage and coordinate various improvement projects across functional areas and across sites.