QA Associate Director, Compliance (Biotech)
Today, Lonza is a global leader in life sciences operating across five 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.
We are thrilled to announce an outstanding opportunity for an Associate Director, Compliance at Lonza AG, based in New Hampshire, USA! As one of the world's largest healthcare manufacturing organizations, Lonza is committed to encouraging a safe, controlled work environment and promoting continuous growth. The Associate Director, Compliance will play a vital role in ensuring the flawless implementation of our ambitious projects within the customer-dedicated area!
Key responsibilities:
Collaborate with the Asset Head to implement critical initiatives and cultivate a culture of quality awareness and GMP compliance.
Coordinate GMP activities and ensure that manufacturing related GMP systems and controls meet Global Quality standards and applicable regulatory requirements.
Liaise with the customer on a regular basis and participate directly in Joint Quality Steering Committees to ensure QA and compliance activities meet their expectations.
Coordinate change control, deviation and CAPA lifecycle, GMP compliance, on the floor operational support, batch record review and lot release, review and approval of technical documentation and oversight of validation activities.
Ensure objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
Provide general direction and support and act as a point of escalation for QA staff and customers.
Partner with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
Attend and/or co-chair Change Control Committee, Deviations Review Board and CAPA Board meetings.
Lead and supervise Key Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management.
Perform Raw Material and Lot Disposition activities.
Identify and implement improvements to quality processes.
Develop team goals, supervise progress and ensure continuous improvement.
Conduct regularly scheduled team meetings to review objectives, provide support and feedback and assist in resolving issues.
Participate in the hiring process, provide performance feedback, coach, mentor and support career development.
Support Audits and Inspections and act as SME for Compliance and Quality Records as needed.
Perform other duties as assigned.
Key requirements:
Bachelor's Degree or equivalent experience required.
5-10 years of proven experience in a related field.
Outstanding communication and teamwork skills.
Strong ability to determine priorities and thrive in a fast-paced, sophisticated environment.
Demonstrated ability to successfully implement and lead all aspects of compliance processes.
Proven track record of leadership and expertise in relevant manufacturing areas.
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.
