Quality Director

Join to apply for the Quality Director role at Centor
.

Company

Summary:

Centor is a Gerresheimer company. Centor/Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, infusion, dropper and syrup bottles and more.

Centor/Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: ).

The Quality Director will lead and manage the Quality Assurance function for the prescription bottle injection molding operation and primarily packing products. The Quality Director is a strategic leader focuses on driving continuous improvement, ensuring process excellence, maintaining compliance with regulatory standards, and enhancing product quality to meet customer expectations. The position will collaborate cross-functionally to promote a culture of quality, operational efficiency and sustainable process improvements.

• Provide strong leadership to the Quality team, including hiring, coaching, and developing staff.
• Develop and execute the quality strategy to align with the organization’s business goals and customer expectations.
• Serve as a proactive advisor to the leadership team on quality trends, risks, and improvements.
• Drive, implement, and maintain robust Quality Management Systems aligned with ISO 9001, ISO 13485 or other relevant standards.
• Oversee audits (internal, customer, and regulatory) and ensure compliance with applicable quality and safety regulations.
• Act as the key point of contact for regulatory agencies, customers, and external partners regarding quality-related matters.
• Develop and monitor Key Performance Indicators (KPIs) related to quality performance (e.g., scrap rates, customer complaints, defect levels).
• Lead continuous improvement initiatives (e.g., Lean, Six Sigma, Kaizen) to enhance product quality, reduce defects, and optimize processes.
• Identify and implement corrective and preventive actions (CAPA) to address process gaps and quality issues.
• Drive consistency and process control across injection molding operations through standardization, process validation, and root cause analysis.
• Collaborate with Operations and Engineering teams to ensure quality requirements are integrated into product design and manufacturing processes.
• Support continuous training and development of teams to embed a quality-first mindset across all levels.
• Collaborate with customers to resolve quality issues effectively and maintain high levels of customer satisfaction.
• Oversee complaint investigations, ensuring timely resolution and implementation of preventive measures.
• Analyze quality-related data to identify trends, drive improvements, and measure success.
• Prepare and present quality performance reports to senior leadership.

• Strong knowledge of ISO 9001, ISO 13485 or similar quality systems.
• Proficient in root cause analysis (RCA), CAPA, SPC, Program Management (APQP) and statistical analysis tools.
• Exceptional leadership, excellent communication, decision-making, and problem-solving skills.
• Ability to work cross‑functionally and matrix environment, driving quality and process improvement initiatives.

• Results‑oriented mindset with a focus on driving measurable improvements.
• Collaborative and influential leadership style.
• High attention to detail and analytical mindset.
• Ability to thrive in a dynamic and fast‑paced manufacturing environment.
• Change management and continuous improvement…