Director, Quality Site Head

Today, Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 is the leading source of Quality/Regulatory-related expertise and is responsible for providing the strategic leadership and management to approximately 55 people in the quality assurance and quality control functions.  A great candidate will have strong leadership capabilities, envisioning and driving collaboration, high morale, quality culture, and innovation with the goal of building a world-class team.  We are looking for someone comfortable working in a matrix organization, effective with cross-functional and global projects, someone who can conceptualize where we need to be, how to get there, and drive ideas to completion. You will be 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.

Key responsibilities:

• Develop and implement the site Quality strategy commensurate with the global 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 efficiency.  Ensure systems are extraordinary and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability. 

• Develop, implement and supervise Quality programs, policies and procedures to ensure compliance with GxP standards, ISO standards, corporate policies, FDA and other regulatory body regulations and guidelines.

• Setting and driving compliance to department, site and global level critical metrics

• You will represent the company externally with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction. Lead all aspects of all customer and regulatory audits and inspections and corrective action programs in response thereto.

• Build active training and development plans for Quality staff with the objective of driving the overall competence and integrity of the site's Quality functions.

• Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent the Lonza on quality and GxP compliance issues that are specific to the site.

Key requirements:

• Master`s Degree or equivalent experience in a Life Sciences, engineering or Quality Management or related science field.
• Proficient in both English and French languages

• Extensive experience as a leader within quality assurance, quality control, and regulatory compliance.

• Meaningful direct job-related experience in GMP facility manufacturing products regulated by European and US Health Authorities, with significant experience in Quality Management.

• Experience with lean manufacturing practices.

• Solid understanding of:
  • Aseptic practices and clean room operations
  • Statistical and auditing techniques
  • Environmental control procedures/equipment

• Experience of GxP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products.
• Successful 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.
• Proven experience with promoting and establishing a culture of empowerment, curiosity, accountability and excellent problem-solving skills.

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. Our mission is to deliver quality products that support research, manufacturing and testing of life-saving therapies for our community.

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.