Director, Quality Operations Support

Responsibilities

• Support the sites in quality operational activities including regulatory inspections and customer audits, investigation reviews, and batch record reviews related oversight activities
• Participates in the BU and site’s Quality Management Review meetings and Inspection Readiness meetings; and verifies effectiveness of the Quality Systems through site visits and deviation/CAPA reviews
• Collaborates between sites and customers for finalizing quality agreements to standardize the requirements across all sites
• Provides technical and quality support for the implementation of global standards and procedures at the sites
• Acts as an extension of the BU Quality Head when attending site leadership team meetings as well as quality team meetings
• Develops and delivers various training to the sites to emphasize compliance to site and global procedures
• Trains on leading qualification programs (e.g., Investigations) at the sites
• Provides technical support as required for the implementation of electronic systems such as DMS and LIMS at the sites
• Participates in the development of responses at the sites to address regulatory inspection findings
• Facilitates and reviews gap assessments performed by the sites for inspectional findings across the network; and to corporate procedures and standards
• Supports the sites in meeting requirements, as needed
• Readily available to travel to the sites, to assess the Quality Systems, provide trainings and during inspection readiness preparation activities (facility walkthroughs) and during regulatory inspections
• May serve as staff augmentation on an interim basis, in Quality Leadership; and including staff reviews/goal setting, as needed

Qualifications

• B.S./B.A. or M.S. degree in Chemistry, Microbiology, Chemical Engineering or related field
• 15+ years of experience in the pharmaceutical industry, with at least 8 of those years of experience being in Quality, Quality Assurance, and/or Quality Systems/Compliance, and at least 5 of supervisory experience
• Strong knowledge of the pharmaceutical industry regulations applicable to API and Biologic manufacturers
• Demonstrated experience in mentoring and coaching, with ability to motivate teams to reach a common goal
• Strategic thinking—problem solver