POSITION TITLE: Quality Manager
REPORT TO: Director of Quality
SUPERVISES/DIRECTS: QA Specialist and Support Staff
Responsibilities include training and managing Commercial Scale QA personnel, designing, and implementing QA programs, and ensuring that all GMP requirements are satisfied. The Quality Manager will report directly to the Director of Quality and supervise the Quality Assurance Specialist and support staff as project or work conditions require.
- Ability to set-up, maintain and perform various manufacturing related quality control/assurance activities as required for a GMP compliant Fill/Finish operation.
- Develop protocols in compliance with IQ/OQ/PQ requirements and industry guidelines as related to quality control/assurance manufacturing activities.
- Develop SOPs for all quality related activities as required for a GMP compliant Fill/Finish operation.
- Oversee the contract manufacturing facility for compliant release of final products. This includes but is not limited to batch records review and approval.
- Lead the timely resolution and successful closure of deviations/CAPAs/Investigations, and NCRs.
- Design and implement protocols to validate and monitor the various quality, manufacturing activities or systems, such as, WFI, air handling, etc., in compliance with industry guidelines.
- Ability to manage vendor, client and FDA audits, and initiate the appropriate documentation required.
- Train and supervise all subordinate employees for all quality control/assurance activities within manufacturing areas.
- Perform all duties and all quality control/assurance activities according to the applicable guidelines, i.e. FDA, GMP, and ICH etc.
- Perform various quality duties and initiate appropriate documentation as required.
- Oversee other QA processes such as receipt and release of raw materials and automation activities, and management of other ongoing projects.
- Oversee the Environmental Monitoring program for the manufacturing facility.
- Ability to perform technical evaluation of quality control/assurance related information and provide management with status reports including information required for decision-making purposes.
- Ability to initiate problem-solving and technical decision-making commensurate with level of experience.
- Perform other related duties and responsibilities as assigned.
- Bachelors or Master’s degree in Chemistry, Biology, or related scientific discipline and a minimum of seven (7) to ten (10) years of managerial experience in an aseptic manufacturing GMP environment.
- Experience in a CMO environment is preferred.
- Demonstrated ability to effectively supervise and direct personnel and to plan and direct medium to large projects.
- Oral and written communication skill must be at a level appropriate for effective in-house communications, client contact and report preparation.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .