Manager CAPA

JOB DESCRIPTION:

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.

The Opportunity

Join us at Abbott Diabetes Care (ADC) in our mission to help individuals with diabetes lead active fulfilling lives. Were focused on helping people manage their health more effectively and comfortably with life-changing products that provide accurate data to drive better-informed decisions. As CAPA Manager youll lead a high-impact program that ensures compliance fosters innovation and influences global quality strategieswhile developing a talented team and partnering with senior leadership.

In this role you will own the strategic direction and execution of our CAPA programa cornerstone of global compliance and continuous improvement. Youll lead investigations drive metrics and anticipate regulatory trends to position ADC for future success. This role offers visibility at the highest levels of the organization and the opportunity to influence global quality systems..

This position will be based out of Abbott Diabetes Care Division in Alameda CA.

What Youll Work On

• Lead strategic planning for CAPA goals metrics and continuous improvement initiatives.
• Anticipate regulatory changes and proactively manage risk.
• Establishment and maintenance of Quality System policies systems and procedures as needed to ensure compliance of the CAPA program.
• 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.
• Oversee CAPA investigations and ensure timely thorough and compliant documentation.
• Drive cross-functional collaboration for CAPA program across Operations R&D Marketing Supply Chain Quality and Regulatory.
• 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.
• Execute the Executive Management Review Program and present key quality metrics to senior leadership.
• 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).
• Serves as the primary CAPA system contact during regulatory inspections and Corporate AQR audits.
• Foster a culture of growth and opportunity through coaching and development.
• Develop maintain and manage the department budget and related goals for the CAPA program.

Required Qualifications

• B.S. or an equivalent combination of education and work experience will be accepted
• 5 years experience in a regulated environment to be able to understand complex processes.
• 5 years related experience in a quality discipline CAPA preferred.
• 5 years management experience.
• Good working knowledge of regulations and standards affecting IVDs and Medical Devices.
• 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.

Preferred Qualifications

• Strategic and forward-thinking with a global perspective.
• Highly collaborative and influential across all levels.
• Calm under pressure; strong audit and inspection presence.
• Committed to continuous improvement and employee development
• Ability to travel approximately 10% including internationally.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Manager