Quality Assurance Compliance Specialist, Supplier Management

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.

Lonza Tampa, Florida is looking for an experienced Quality Assurance Compliance Specialist with the responsibility to ensure supplier quality compliance, both at initial compliance and ongoing conformance to established quality assurance processes and standards.

Alternatively, conducts internal production / process and manufacturing quality control audits and risk assessments. The role is a member of the site Quality Compliance team.

Key responsibilities :

Oversees, manages, implements, and evaluates the supplier management program in accordance with the local, federal, and EU regulations as well as Lonza procedures.

Evaluation, monitoring, qualification, disqualification, and re-evaluation of the supplier of materials and / or services.

Conducts audits of suppliers to ensure continued supplier quality and ensuring minimal disruption to the supply chain ensuring continued manufacturing and testing processes.

Support for compliance with change controls, CAPA, investigations, deviations, and OOS.

Performs document reviews of SOPs, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures.

May also review raw materials, work orders, validation, and MSAT reports.

Independently writes SOPs or associated documentation.

Independently approves SOPs, customer audits, and regulatory CAPA.

Collaborate with cross-functional teams to identify and evaluate supplier quality issues and implement corrective actions to ensure high-quality standards are consistently met.

Communicate effectively with internal and external stakeholders, including senior management, to provide updates on supplier quality performance and contribute to strategic decision-making.

Participates in the resolution of supplier-related quality problems, including internal failures, customer complaints, and audit findings by managing nonconforming product disposition, supplier investigation of the root cause, corrective action planning, implementation, and verification of effectiveness activities

Able to participate in internal audits, client audits, and / or regulatory inspections.

Assist, lead, and / or manage quality improvement initiatives as needed.

Trains new team members.

Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear.

Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and / or opportunities to management and correct where possible.

Stop work where deemed necessary to maintain safety

Able to work with minimal supervision, balance multiple projects & prioritize work

Other tasks as assigned by Sr. QA Manager, Compliance.

Key requirements :

Bachelor's Degree in Science or Engineering-related field.

Substantial Quality Compliance experience within the pharmaceutical / biotech industry is required. Preferred experience working in a commercial drug product environment.

5 years of Supplier Management experience (minimum).

Demonstrated supplier management and audit experience.

Excellent communication skills (written and oral) with the ability to influence people and outcomes.

Ability to work in a deadline-driven environment.

Candidates must be self-starters.

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 a disability, protected veteran status, or any other characteristic protected by law.

Reference : R60605