Manager, Quality Operations

Curia • City of Rensselaer, NY

4d • Onsite

About The Position

The Quality Operations Manager is responsible for oversight of the conditions and activities in the API manufacturing areas to ensure continual compliance with cGMP and also oversee disposition team. This position requires expertise in all aspects of manufacturing of APIs, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing environment and will report metrics to site management on a regular basis.

Requirements

• Bachelor’s Degree in Microbiology, Chemistry or related field
• 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
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Advanced degree in related field
• Prior work experience in a CMO

Responsibilities

• Assist the Site Quality Head with 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
• Ensures 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
• Ensures all operational deviations are appropriately investigated, product impact determined and documented within the Quality System prior to disposition
• Responsible to oversee site walkthrough program, identify key themes of improvement and drive improvement
• Responsible for developing and maintaining 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
• Ensures, any manufacturing quality issues are promptly escalated through NTM process
• Develop and maintain leading indicator metrics for good quality oversight on the floor

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Manager