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Abbott · 10 hours ago

Manager CAPA

Alameda, CA

Full-time

Onsite

Senior Level

$147K/yr - $293K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a CAPA Manager to lead a high-impact program ensuring compliance and fostering innovation within the Abbott Diabetes Care division. The role involves strategic planning, overseeing investigations, and collaborating across departments to enhance quality systems.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

H1B Sponsor Likely

Responsibilities

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

Qualification

CAPA managementQuality System complianceRegulatory knowledgeProject ManagementProblem-SolvingComputer literacyVerbal communicationWritten communicationInterpersonal skillsTeam leadership

Required

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

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

Benefits

Career development with an international company where you can grow the career you dream of.

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical 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 bachelor’s degree.

Company

Abbott

Glassdoor3.8

Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.

Founded in 1888

Illinois City, Illinois, USA

10001+ employees

https://www.abbott.com

H1B Sponsorship

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2021 (1)