Associate Director - QA

Role Summary

The Associate Director is a member of the Quality Assurance Compliance organization. The role supports the development and implementation of the Indianapolis Active Pharmaceutical Ingredient (IAPI) Quality Management System (QMS) and its elements across the site, providing end-to-end process ownership, oversight and execution of QMS deliverables throughout the QMS life cycle to ensure CGMP compliance with local, global, regulatory and industry requirements.

The role collaborates with quality and other site functions to integrate these requirements into the manufacturing operations and support areas.

• Assume end-to-end process ownership and oversight of QMS elements at the site (e.g. change management, deviation management, inspection readiness, pharmacovigilance)
• Provide coaching, mentoring, training and technical expertise to the site as the Subject Matter Expert (SME) for any given QMS process
• Tabulate and facilitate metrics reporting to the Site Lead Team and for monitoring and continuous improvement of the QMS processes
• Provide support for internal and external audits/inspections (e.g. readiness, back/front room support, coordination of inspection responses)
• Lead and/or participate in the site Inspection Readiness Team and its initiatives
• Provide QA support to local regulatory and global affiliates for GMP certification registrations, renewals and submissions
• Stay abreast of latest trends, applications, and compliance requirements. Share trends at site applicable forums and establish strategies/actions for deployment when applicable
• Participate in management review activities of the global quality systems
• Contribute to the development of area specific procedures and supporting documents (e.g. required tools, resource documents and supplemental materials)
• Review and approve quality system related documents

• Required: Bachelor’s Degree in a science/technology/health care related field
• Required: 5+ years of CGMP pharmaceutical experience
• Preferred: Previous QA/QC experience in a CGMP environment
• Preferred: Demonstrated ability to communicate effectively, both written and verbal, and to influence others
• Preferred: Demonstrated ability to prioritize and handle multiple tasks concurrently
• Preferred: Cognitive abilities including problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
• Preferred: Previous experience leading and implementing projects at a site level
• Preferred: Experience in pharmacovigilance
• Preferred: Ability to present information and concepts at all levels of the organization

• Bachelor’s Degree in a science/technology/health care related field

• Tasks may require entering manufacturing areas which require wearing appropriate PPE and adherence to local safety guidelines
• After-hours and weekend support may be required as necessary