QA Product Manager

Lonza•Tampa, FL

3d•Onsite

About The Position

The QA Product Manager based at our Tampa, Florida and plays a critical role in ensuring customer products meet the highest quality and compliance standards. As a dedicated quality advocate and subject matter expert, you will partner closely with internal teams and customers to support products across their full lifecycle. What you will get: A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus Medical, dental and vision insurance 401(k) matching plan Life insurance, as well as short-term and long-term disability insurance Employee assistance programs Paid time off (PTO) Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Requirements

Extensive relevant experience, ideally within a pharma cGMP setting
Bachelor’s degree or equivalent relevant experience
Experience working in a QA role within a regulated pharmaceutical or medical device environment, supporting customer products and programs
Strong working knowledge of FDA regulations and cGMP requirements, with the ability to apply them pragmatically
Proven ability to make sound quality decisions, solve problems, and ensure compliance in a fast-paced environment
Excellent written and verbal communication skills, with the ability to build effective relationships across functions and with customers
Demonstrated ability to manage priorities independently, handle fluctuating workloads, and deliver high-quality outcomes

Responsibilities

Act as the primary QA point of contact and customer advocate, providing product- and process-specific expertise throughout the product lifecycle
Lead, review, and approve customer-facing quality documentation, including Deviations, Investigations, Change Controls, CAPAs, Master Batch Records, Validation documents, APRs, and Product Specifications
Coordinate cross-functional teams and customer stakeholders to ensure timely and accurate review, approval, and execution of quality activities
Develop and maintain Quality Technical Agreements, aligning quality systems, timelines, and expectations with customers
Build strong customer partnerships through regular communication, meetings, and issue resolution, ensuring alignment and trust
Generate and analyze quality metrics, trackers, and reports to communicate product and quality system health to management and customers
Support customer audits and Health Authority inspections, contributing to continuous improvement and compliance excellence