Job DescriptionManager, Quality Operations in Rensselaer, NYThe 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.
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
Qualifications- 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
- Strong background in deviations, batch review and disposition
Other Qualifications- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Preferred- Advanced degree in related field
- Prior work experience in a CMO
Pay Range: $106,000-$137,000
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.
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