Senior QA Product Manager
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Senior QA Product Manager is an experienced Quality professional that oversees customer product/programs. This position is a dedicated customer advocate and SME throughout the product lifecycle. The Senior QA Product Manager is the liaison between internal teams, service providers and customers to ensure accurate and timely communications, expert troubleshooting when issues arise, and to ensure on-time delivery.
Key Responsibilities:
- Provide exemplary customer service and serve as primary QA point of contact and product/process-specific SME for customers.
- Lead, review and / or approve quality documentation for customers such as Deviations, Investigations, Master Batch Records, Change Controls, CAPAs, Validation Protocols and Reports, Annual Product Quality Reviews and Product Specifications.
- Coordinate required functions across the site and with customers to ensure timely review and approval of all quality related documentation.
- Develop Quality Technical Agreements and collaborate with customers to align quality systems, timelines and expectations.
- 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 related to products.
- Provide support during customer audits and Health Authorities inspections.
- Participate in other activities as assigned by the Associate Director of QA.
Key Requirements:
- Demonstrated Expertise (7-10 years) providing SME knowledge for product/processes in pharmaceutical industries.
- Experience working in Quality Assurance, QMS, Validation and / or Compliance.
- Experience in a regulated industry (e.g., U.S. Food and Drug Administration).
- Bachelor’s degree in science required (Chemistry, Microbiology or Biology preferred).
- Working knowledge of FDA regulations for drugs and/or medical devices.
- Strong skill in written and oral communications and in establishing effective interpersonal relationships internally and with customers.
- Advanced 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 understanding and contribution to company and departmental goals.
- Demonstrated Problem solving skills while ensuring quality and compliance.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.