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.
As Compliance Head you’re responsible to set strategy and direction for Site Quality System, current with Lonza quality system , industry trends, health authority guidelines and regulations. You contribute to the development and maintenance of global quality systems in alignment with Corporate standards and regulatory requirements. You will Design and implement Quality System improvements while ensuring high level (internal / external) Customer support and are Responsible for staff development.
- Provide general direction, support and act as a point of escalation for Quality System related items staff and customers. Ensure Quality System objectives are delivered on-time and in-full to internal and external customers while aligning with respective Quality Agreements, Lonza SOP’s and Regulations.
- Implement Site Quality System, in line with Lonza policies , industry trends, health authority guidelines and regulations.
- Build and maintain expertise in the various Quality disciplines.
- Ensure output and expertise is efficient and effective for applicable roles.
- Serve as member of Senior Quality for escalations to support Operations and Customer related issues as they arise.
- Ensure escalation to Site Head of Quality of significant events related to non-compliance and potential impact on site compliance and patient safety.
- Interface with FDA and other regulatory agencies during regulatory inspections. Ensure regulatory commitments are met on time and contribute to sustainable actions.
- Interface with Customers during Customer audits. Ensure customer audit commitments are met on time and contribute to sustainable actions.
- Responsible for effective internal audit program, with objective to self-identify potential non-compliances. Ensure corrective and preventative measures are timely and sustainable.
- Responsible for Site Risk Register, SMF and VMP of the site and to drive continues improvements for Quality Systems.
- Chairs Quality Council meetings and ensures implementation of follow up actions.
- Develops the team. Set team goals, individual development plans and ensure continuous improvement, team efficiencies, innovative thinking, track progress and implementation. Oversee training, mentor, and develop in Quality principles.
- Conduct objective setting and regularly scheduled sessions with individuals of team to review objectives, provide feedback and provide guidance for personnel advancement
- Interview and hire personnel to provide responsible, experienced people to carry out job function
- Bachelor’s Degree or equivalent experience in related Scientific field
- Extensive experience in GMP environment
- Experience in Quality Assurance/Compliance or similar discipline
- Experienced in managing direct reports
- Biotechnology manufacturing background is preferred
- Deep knowledge of GMP’s and regulations. Demonstrated decision making skills.
- Experience with Track wise, SAP, electronic document management systems as preferred
- Demonstrated ability to mentor and coach employees to achieve common goals.
- Self-starter, excellent written and verbal communicator at all levels
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.