Manager, Quality Operations

Manager, Quality Operations in Rensselaer, NYBuild your future at Curia, where our work has the power to save livesCuria is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.We proudly offerGenerous benefit options (eligible first day of employment)Paid training, vacation and holidays (vacation accrual begins on first day of employment)Career advancement opportunitiesEducation reimbursement401K program with matching contributionsLearning platformAnd more!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.ResponsibilitiesAssist the Site Quality Head with the development, implementation, and strict adherence to the quality assurance programDevelop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materialsEnsures there is a robust batch disposition program including a holistic batch record review training for Ops and QualityEnsure that the data integrity principles are understood and implemented consistently throughout the siteEnsures all operational deviations are appropriately investigated, product impact determined and documented within the Quality System prior to dispositionResponsible to oversee site walkthrough program, identify key themes of improvement and drive improvementResponsible for developing and maintaining real time batch record review program in placeEnsure there is a robust cleaning and sanitization program in placeDevelops and maintains a robust disposition review process involving all key stake holders, drives accountability for RFT and Yield to Release metricsReview and approve all major deviations initiated for manufacturing activitiesPartner 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 activitiesCommunicate effectively with internal and external customers making sure that the Curia values and business goals are consistently achievedEnsure a robust line clearance process is in place and adheredWill act as an interface with customers for any batch record related queries, manufacturing deviations and yield to release dataEnsures, any manufacturing quality issues are promptly escalated through NTM processDevelop and maintain leading indicator metrics for good quality oversight on the floorQualificationsBachelor's Degree in Microbiology, Chemistry or related fieldMinimum 8 -10 years of related industrial GMP experience in an FDA-regulated pharmaceutical environment, including 2 years' supervisory experience, ORMaster'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 experienceOther QualificationsMust pass a background checkMust pass a drug screenMay be required to pass Occupational Health ScreeningPreferred* Advanced degree in related field* Prior work experience in a CMOPay Range: $101,000-$125,000Education, 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. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.