Director QA Operations

About the role

Cilag AG, a Johnson & Johnson company based in Schaffhausen, is looking for a Director of Quality Assurance to lead its QA department. You will ensure that high-quality products reach patients, shape how products are manufactured and released according to cGMP, and organise and lead QA within the Quality matrix framework in line with internal and external regulations and international regulatory requirements.

Key responsibilities

• Shape and lead all Quality and Compliance programs within QA, covering clinical and commercial manufacturing, and ensure they meet J&J and governmental environmental, health, safety, quality and regulatory requirements.
• Guard international cGMP compliance, including Swiss law, EU cGMP, PIC/S GMP guides, the relevant parts of 21 CFR and J&J quality policies.
• Oversee QA disposition of raw materials, intermediates, APIs and finished products in line with cGMP and SOPs, keeping supply to patients on track.
• Inspire, coach and grow the QA leadership team, including performance goals and appraisals, and hold overall accountability for people matters and disciplinary responsibility for QA associates.
• Review and approve SOPs and work instructions, and assess and approve deviations, investigation reports, trend reports and PQRs, defining the right actions.
• Keep the site inspection-ready, lead Health Authority, regulatory compliance and customer inspections and audits, and act as Sub Process Execution Owner for External Inspections.
• Define and deliver quality metrics and targets, drive continuous improvement, supervise training and develop employees.
• Act as a trusted advisor to site and JSC management, flagging issues that could affect products or the business, and foster a high-performance culture through training, assignments, career planning and succession planning.

Required profile

• University degree or MSc in pharmaceutical or natural sciences; a PhD is a plus.
• 10-12 years of experience in a significant leadership position in the biological and/or pharmaceutical industry.
• At least 5 years of experience in a Quality leadership role.
• Experience in sterile manufacturing.
• Excellent English; German is a plus.

Required skills

• Strong knowledge of FDA/EMA regulatory requirements for biologics or pharmaceuticals and application of cGMP and international guidelines.
• Collaborative, cross-functional approach across Quality, Manufacturing, Supply Chain and Regulatory teams and sites.
• Computer proficiency such as MS Office and SAP, with openness to AI and digital tools.
• Analytical skills, independence, and the ability to deliver under tight deadlines.