Manager, Quality Assurance

Manager, Quality Assurance

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Quality Assurance Manager is responsible for oversight of the conditions and activities in the API manufacturing areas to ensure continual compliance with cGMP. 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. Join our talented workforce, where a commitment to excellence and a customer-focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture. We proudly offer generous benefit options, paid training, vacation and holidays, career advancement opportunities, education reimbursement, a 401k program, a learning platform, and more!

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
• Oversee and assist with the site training and auditing programs, changes, investigations, validations, approval of specifications and methods, review of data and manufacturing records, and vendor qualifications
• Ensure immediate action is taken when non-compliance and / or undesired behavior by personnel in the facility is observed
• Make recommendations regarding facilities, equipment, personnel, procedures, and systems to carry out the quality function
• Ensure that the data integrity principles are understood and implemented consistently throughout the site
• Lead process improvement program including collaboration with Operations, Quality, and / or Training Leadership to make recommendations for enhancements to quality processes, teaching / coaching, and implementation of procedures
• Coordinate corrective action training based on both immediate and long-term feedback gathered from observations and evaluations
• Assist Site Quality Head during inspections by regulatory authorities, including implementing inspection-readiness programs and ensuring that proper CAPAs are prepared and completed on time
• 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 daily inspections are carried out

Qualifications :

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. #LI-KD1