Head of Quality, Synaffix

Lonza

Oss, Netherlands

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.

What 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.

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