QUALITY PRODUCT MANAGER

FORMULATED Solutions LLC•Largo, FL

About The Position

THE QUALITY PRODUCT MANAGER IS RESPONSIBLE FOR ENSURING THAT THE PRODUCTS MANUFACTURED IN THE FACILITY CONSISTENTLY MEET QUALITY, SAFETY, AND REGULATORY STANDARDS ACROSS THEIR ENTIRE LIFECYCLE. THIS ROLE INTEGRATES QUALITY OVERSIGHT WITH PRODUCT STRATEGY BY DIRECTLY PARTNERING WITH AR&D, MANUFACTURING, CUSTOMER SERVICE AND SUPPLY CHAIN WHILE MAINTAINING A RELATIONSHIP WITH THE CLIENT TO EMBED QUALITY-BY-DESIGN PRINCIPLES, MONITOR PRODUCT PERFORMANCE, MANAGE RISKS, AND DRIVE CONTINUOUS QUALITY IMPROVEMENT.

Requirements

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 Field (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.
Working knowledge of FDA/GMP regulations for drug products, OTC products and/or medical devices.
Skill in effective 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 execute accordingly.
Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
Ability to perform effectively in a fast-paced environment, under conditions of fluctuating workload and frequent changes in priority.
Ability to handle and resolve recurring problems.
Ability to concentrate in such an environment and perform quality work.
Strong initiative, technical commitment and contribution to company and departmental goals

Nice To Haves

Analytica; Chemistry / Quality Control Experience preferred

Responsibilities

Provide customer service and serve as primary Quality point of contact for customers.
Review and approve quality documents for customers such as Deviations, Master Batch Records, Change Controls, Validation Protocols/Reports, Finished Goods specifications and Test Methods.
Coordinate required functions across the site and with internal & external 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 Formulated Solutions quality systems.
Develop and nurture customer partnership to ensure alignment and consensus on Quality related topics.
Participate in and coordinate meetings with customers as part of Quality 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.
Provide support for and participate in the Internal Audit Program by performing site audits as required by Quality Management.
Provide support for and participate 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 Quality Improvement and customer satisfaction.
Participate in other activities as assigned by the Senior Director of Site Quality.