Manager, Quality Operations

Responsibilities

• Aid the Site Quality Head in the development, implementation, and strict adherence to the quality assurance program.
• Develop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materials.
• Ensure there is a robust batch disposition program including a holistic batch record review training for Ops and Quality.
• Ensure that the data integrity principles are understood and implemented consistently throughout the site.
• Ensure all operational deviations are appropriately investigated, product impact determined and documented within the Quality System prior to disposition.
• Oversee site walkthrough program, identify key themes of improvement and drive improvement.
• Develop and maintain real time batch record review program in place.
• Ensure there is a robust cleaning and sanitization program in place.
• Develops and maintains a robust disposition review process involving all key stake holders, drives accountability for RFT and Yield to Release metrics.
• Review and approve all major deviations initiated for manufacturing activities.
• Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong, site-wide quality culture while achieving the site business goals.
• This includes also leading and supporting site-wide cGMP training activities.
• Communicate effectively with internal and external customers making sure that the Curia values and business goals are consistently achieved.
• Ensure a robust line clearance process is in place and adhered.
• Will act as an interface with customers for any batch record related queries, manufacturing deviations and yield to release data.
• Ensure any manufacturing quality issues are promptly escalated through NTM process.
• Develop and maintain leading indicator metrics for good quality oversight on the floor.

Requirements

• Bachelor’s Degree in Microbiology, Chemistry or related field, or Master’s Degree in Microbiology, Chemistry or related field with minimum 3 years of related industrial GMP experience in an FDA-regulated pharmaceutical environment, including 2 years’ supervisory experience.
• Minimum 8 -10 years of related industrial GMP experience in an FDA-regulated pharmaceutical environment, including 2 years’ supervisory experience, OR Master’s Degree in Microbiology, Chemistry or related field with minimum 3 years of related industrial GMP experience in an FDA-regulated pharmaceutical environment, including 2 years’ supervisory experience.
• Strong background in deviations, batch review and disposition.

Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.
• Prior work experience in a CMO.