Head of Quality, Synaffix

Head of Quality , Synnafix

Location : Oss

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.

Lonza acquired Synaffix, a biotechnology company focused on commercializing its clinical-stage technology platform for the development of more effective and better tolerated antibody-drug conjugates (ADCs.)

As the Head of Quality , you will be the hands-on leader who not only oversees daily operations but also actively contributes to system improvements. You have a passion for quality and understand the importance of continuously innovating and enhancing processes. In this role, you will lead a team of five quality officers , providing direction and coaching to elevate both the quality of work and the motivation of your team. We are seeking a pragmatic candidate who excels at thinking along with the team while being flexible enough to adapt strategies without losing focus on quality objectives . It is essential that you have gained experience in both smaller and larger organizations, enabling you to effectively tackle the diverse challenges we encounter .

The quality organization at Synaffix is relatively new and the the Head of Quality of Synaffix will lead and further mature this organization. Assuring the overall compliance state of the organization with regards to cGMP. The head of quality is responsible for supplier and contractor quality oversight and management; accomplishes corporate business objectives by developing site quality systems and acts as Key Account Quality Manager for customers, including during quality audits. The head of quality will further lead, support and develop the QA staff.

W hat you’ll do:

• Serve as the leading source of Quality and GMP-related expertise within the site, providing strategic leadership and management for the Site's Quality organization.

• Lead the Site Quality team to ensure that teamwork, high morale, and innovation are integral parts of the team’s culture.

• Develop and implement a Quality strategy that aligns with the overall company plan, ensuring linkage with customer needs and broader business objectives .

• Implement and monitor Quality programs, policies, and procedures to guarantee compliance with GMP standards, as well as corporate, FDA, EMA, and other regulatory guidelines.

• Evaluate existing Quality systems and processes, suggesting and implementing refinements to achieve Lonza AG’s long-term goals.

• Establish and implement active training and development plans for Quality staff, promoting the competence and integrity of the Quality team.

• Establish and maintain positive working relationships with customers, representing Lonza AG on site-specific quality and cGMP compliance issues.

• Act as the company’s Quality expert, providing well-informed, actionable support to CMC, customers, CDMOs, and other functions as needed.

What we’re looking for:

• BSc degree in Life Sciences, Engineering, Quality Management, or a related field, or equivalent experience.

• Over 10 years of direct experience in GMP manufacturing and Quality Management of products regulated by FDA CBER, CDER, or EMA.

• Minimum of 4 years in senior leadership positions.

• Experience in API manufacturing, preferably supplying pharmaceutical customers, such as a CDMO.

• Experienced knowledge of GMP (ICH Q7 / EU GMP part II), GDP, and ISO Standards as applied to biologicals and small molecule manufacturing.

• Regulatory knowledge of CBER, CDER, CDRH, and EMA.

• Strong understanding of current industry trends and the ability to apply the latest technologies.

• Proficiency in GMP manufacturing, including outsource management to CDMOs and auditing techniques.

• No company visa sponsorship available.

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.