CAPA Manager

Description

• 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.
• 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.
•  

Qualifications

• 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.