What are the responsibilities and job description for the Manager, CAPA position at Exela Pharma Sciences?
Position Summary
The CAPA Manager plays a pivotal role in ensuring that organizational CAPA initiatives are executed with the highest standards of quality and efficiency within the sterile pharmaceutical manufacturing environment. This position is responsible for developing, implementing, and overseeing quality assurance processes that support CAPA including Quality Action Report (QAR) and Event Report investigation management strategies, ensuring alignment with business objectives and regulatory requirements. The role requires close collaboration with cross-functional teams to monitor the impact of CAPA implementation, mitigate risks, and drive continuous improvement. The CAPA Manager will lead efforts to establish metrics and reporting mechanisms that provide transparency and accountability throughout the CAPA lifecycle, ensuring that CAPA initiatives deliver intended benefits while maintaining operational excellence and stakeholder satisfaction.
Job Responsibilities
- Develop and maintain comprehensive quality management frameworks tailored to CAPA management processes.
- Collaborate with project managers, business analysts, and stakeholders to define quality standards and success criteria for CAPA initiatives.
- Conduct regular audits and assessments to ensure compliance with established quality standards and identify areas for improvement.
- Monitor key performance indicators (KPIs) related to CAPA quality and report findings to senior leadership.
- Facilitate continuous improvement workshops and incorporate feedback to refine change management methodologies.
- Ensure all CAPA management activities comply with relevant industry regulations and internal policies.
Experience Requirements
- Minimum of 5 years of experience in quality management or CAPA management within pharmaceutical manufacturing.
- Proven experience in developing and implementing quality assurance processes for CAPA initiatives.
- Familiarity with quality standards and FDA regulations.
Education Requirements
- Bachelor’s degree in Business Administration, Quality Management, Engineering, or a related field.