Director, Quality Site Head
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 Director, Quality Site Head for the Kingston, is the leading source of Quality/Regulatory-related expertise and is responsible for providing the strategic leadership and management of the quality assurance and quality control functions. The Quality Site Head is a highly visible member of the site leadership team and will spend the majority of the time onsite to support the key responsibilities of the position.
The Director, Quality Site Head is a highly visible member of the senior site leadership team and will spend the majority of the time onsite to support the key responsibilities listed below.
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Key responsibilities:
- Develop and execute the Kingston Quality strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Quality and business strategies.
- Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity. Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
- Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with relevant ISO standards, corporate policies, and other regulatory body regulations and guidelines.
- Setting and driving compliance to department, site and global KPIs.
- Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction. Oversee all partner and regulatory authority audits and inspections and corrective action programs in response thereto.
- Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Lonza’s long-term objectives.
- Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Kingston Quality functions.
- Establish and maintain a positive working relationship with customers and other regulatory authorities. Represent the Lonza on quality compliance issues that are specific to Kingston.
- Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Kingston Operations, R&D, and other functions as requested.
- Other projects and tasks in support of driving a culture of quality at the site.
Key Requirements:
- Bachelor`s degree in a Life Science discipline, Engineering or Quality Management or related field; Master’s degree preferred
- Extensive experience with quality assurance, quality control, and regulatory compliance in a leadership capacity (10+ years experience)
- Substantial direct job-related experience in the device manufacturing industry working with ISO 13485/9001
- Experience with lean manufacturing practices
- Expert knowledge of GxP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products
- Strong knowledge of current industry trends and has the ability to use the latest technologies
- Demonstrated leader in the field with sustained performance and accomplishments. Ability and experience in turning around and remediating compliance challenges. Ability to plan and budget at a senior level
- Agility to work within fast-paced work environment
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.