CAPA Manager

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 109,000 colleagues serve people in more than 160 countries.
 

Primary Function/Primary Goals/Objectives:

• Responsible for overseeing the organization's Corrective and Preventive Action (CAPA) program, ensuring timely and effective resolution of quality issues, including customer complaints.
• Provide leadership and direction and ensure compliance to Abbott Nutrition Policies and Procedures as well as applicable regulatory bodies.
• Lead site end-to-end CAPA process: issue identification, root cause analysis, action planning, implementation, effectiveness verification, and tracking of CAPA status and outcomes.
• Manage the intake, investigation, and resolution of customer complaints.
• Collaborate with cross-functional teams (including Affiliates) to determine root causes and implement corrective actions.
• Maintain complaint records and ensure timely reporting to regulatory bodies when required.
• Promote a culture of quality and continuous improvement across the organization.
• Manages the hiring, staffing and maintenance of a diverse and effective workforce.                 
• Responsible for career development/planning, performance and pay discussions of team
• Provides managerial leadership, coaching/feedback and development for direct reports and business partners.
• Direct the efforts of others in the achievement of the strategic and operational objectives of the group. 

Major Responsibilities:

• Manage and provide leadership to establish an efficient process to trouble and resolve plant events.
• Facilitate structured problem-solving methodologies (e.g., 5 Whys, Fishbone, FMEA).
• Identify trends and systemic issues through data analysis and audits.
• Monitor trending data to identify recurring issues and ensure proactive resolution and at the same time develop and implement preventive strategies to mitigate future risks.
• Prepare and monitor quality metrics to evaluate CAPA performance and ensure alignment with key performance indicators (KPIs).
• Manage complaints activities (including communication and resolving feedback from affiliates) and provide guidance to ensure compliance to Abbott Nutrition Polices and Procedures.
• Collaborate with cross-functional teams to support CAPA implementation
• Maintain accurate and complete CAPA and complaint documentation.
• Train staff on CAPA and complaint handling procedures.
• Promote a culture of quality and continuous improvement across the organization.
• Lead improvement projects focused on enhancing quality, compliance, and operational performance.
• Manages a staff of professional level team members
• Establishes and influences operating policies. Work is guided by general policies and management guidance.
• Interprets and executes policies that directly affect work activities. May contribute to functional strategy within location.
• Provides guidance and technical advice and becomes actively involved as required.
• Anticipates operational issues and develops preventative measures. Solves problems impacting the area in a systematic and clear manner that can be understood by subordinates and colleagues.
• Manages area of responsible related budget.
• Any other duties as assigned by supervisor.

Requirements

• Bachelor of Engineering Degree in  Chemical Engineering, or Engineering related discipline.
• 5 to 10 years of related experience and 3 years in management situation.
• Good leadership and problem-solving skill.
• Good communication and report writing skill.
• Good practical knowledge of GMP in food/ pharmaceutical manufacturing.

The base pay for this position is

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