Site Quality Head

United States, Rockland (Maine)

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 Rockland, ME has an exciting opportunity for a Site Quality Head. This role is a member of the Rockland Site Leadership team. The successful candidate will  join a great team and assure that the site remains under control with respect to GMP/ISO compliance, will collaborate with Operations to solve quality issues (as it applies to the site).  He/She will lead & support Audits & Regulatory Inspections at the Rockland site, direct staff in both QA and QC, support development of manufacturing and process controls and improve quality systems, provide hands-on support to product release and to address production concerns, support IQ/OQ/PQ activities, support customer requests as presented by Scientific Support/Product Manager, support Global Supplier Quality and site Procurement with management of Rockland suppliers. 

Primary Role Responsibilities:

  • Serve as the site source for Quality/Regulatory-related expertise within the site and provide strategic leadership and management for the site`s Quality organization.
  • Provide leadership to the Site Quality organization to ensure that teamwork, high morale,  innovation and continuous improvement are fundamental components of a world-class team.
  • Develop and execute the Rockland Quality strategy commensurate with the overall site Quality Plan. 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 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 GxP standards, ISO standards, corporate policies, FDA and other regulatory body regulations and guidelines (as applicable).
  • Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction. Oversee all customer 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 Rockland Quality functions.
  • Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Rockland Operations, R&D, and other functions as requested.
  • Provide hands-on support for product release activities
  • Perform other duties as assigned.

Skill and/or Education Requirements:

  • Bachelor`s Degree in  a Life science, Engineering  or Quality Management or related science discipline
  • 7+ years direct job related experience in an ISO/GMP facility manufacturing products with a minimum of 5 years’ experience in Quality Management
  • Working knowledge of FDA cGMP requirements, and/or ISO 9000 standards; implementing and auditing these systems.
  • Working knowledge of customer needs and product functions.
  • Experience developing, coordinating and presenting training programs
  • Computer proficiency in standard programs
  • Excellent communication, written and oral
  • Strict attention to detail
  • Demonstrated Time / Priority management skills
  • Demonstrated leadership abilities
  • Demonstrated problem solving abilities and data interpretation skills
  • Logical, strategic thinker
  • Self-motivated and responsible, with a strong work ethic
  • 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.

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. 

Reference: R39740