QA PRODUCT MANAGER

PRIMARY PURPOSE: • Provide customer service and serve as primary QA point of contact for customers. • Review and approve quality documents for customers such as Deviations, Master Batch Records, Change Controls, Validation Protocols and Reports, FG specifications and Test Methods. • Coordinate required functions across the site and with customers to ensure timely review and approval of deviations, change controls, audits CAPAS, corrections and effectiveness checks. • Develop Technical Quality Agreements and collaborate with customers to align customer and FS quality systems. • Develop and nurture customer partnership to ensure alignment and consensus. • Participate and coordinate meetings with customers as part of QA oversight for customer products. • Generate quality metrics, trackers, and reports for management and customers to characterize the health of the client relationship and state of quality systems. • Promote Compliance within the site at all levels and cross functional Teams. • Participate in the Internal Audit Program by performing site audits as required by QA Management. • Provide support during customer audits and Health Authorities inspections. • Support EHS audits (regulatory and customers) to scribe- file documents as required. • Conduct Investigations/CAPAs for quality events, ISO event, calibration events and safety quality related events as required by management. • Promote GMP and safety throughout the facility by training and coaching personnel to quality, regulatory and safety as tasked. • Accurately reviews and records data. • Promote continuous improvement and customer satisfaction. • Participate in other activities as assigned by the Director of QMS. QUALIFICATIONS: • Experience working in Quality Assurance, QMS, Validation and Compliance. • Experience in a regulated industry (e.g., Food and Drug Administration). • Bachelor’s Degree in Science (Chemistry, Microbiology or Biology preferred) required • A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries. CRITICAL SKILLS AND ABILITIES: • Working knowledge of FDA regulations for drugs and/or medical devices. • Skill in written and oral communications and in establishing effective interpersonal relationships. • Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports. • Ability to make quality decisions and act accordingly. • Ability to establish priorities, work independently, productively, and proceed with objectives without supervision. • Ability to perform effectively under conditions of fluctuating workload. • Ability to handle and resolve recurring problems. • Communicate with others clearly and concisely. • Ability to work in a fast-paced environment – sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work. • Strong initiative, technical commitment and contribution to company and departmental goals