- The individual in this leadership position ensures that company products meet defined quality standards through the supervision of product auditing and product release groups. The incumbent oversees review and approval of SOPs, deviation investigations, CAPA management, change control, and trials/planned deviations.
- The QA Manager also prepares reports and analyses and ensures that all documentation meets cGMP and FDA standards.
- This role will also maintain the facility inspection and will host regulatory inspections as well as customer and third party audits while managing all information flow during audits and inspections.
- Additionally, the QA Manager will be heavily involved in selecting, training and evaluating performance of exempt, non-exempt and hourly staff.
- Develop and maintain auditing and release procedures which ensure products released for shipment meet company, customer and FDA standards.
- Responsible for oversight of review and approval of Deviations, procedures, change control, CAPA.
- Provides risk assessment over significant Quality events.
- Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality.
- Leads and guides others in quality driven initiatives in the continuous support of Quality Improvement.
- Represent PMI Quality in discussions with contract customers (questions, investigations, customer metrics).
- Manage preparation for and hosting of regulatory and customer audits. Ensure appropriate CAPAs are generated from audit findings.
- Bachelor’s degree, with preference given to scientific fields of study. Consideration may be given to those candidates who possess a significant amount of experience and specialized training in lieu of a completed Bachelor's degree.
- A minimum of seven to ten (7-10) years of experience working in an FDA regulated industry, including a minimum of five (5) years’ experience in a Quality or closely related role.
- Previous Management/Supervisory experience is required.
- Familiarity with quality assurance and release methods, and the ability to interpret and apply FDA regulations governing these processes are essential.
- Investigation and change control experience are required.
- Working knowledge of food and drug GMPs is required.
- Good oral and written communication skills and excellent interpersonal skills are necessary.
- Must be able to interpret and apply FDA regulations and written procedures.
- Must possess sufficient mobility and auditory and visual acuity to maneuver in manufacturing and packaging facilities and inspect products and written materials.