What you will do
Shape and lead all Quality and Compliance programs within QA, including the activities supporting clinical and commercial manufacturing, ensuring they meet J&J and governmental environmental, health, safety, quality and regulatory requirements.
Be the guardian of international cGMP compliance, including Swiss law, EU cGMP, PIC/S GMP guides, the relevant sections of 21 CFR and J&J quality policies.
Oversee QA disposition of raw materials, intermediates, APIs and finished products in accordance with cGMP and SOPs, and keep supply to patients on track.
Inspire, coach and grow your QA leadership team and beyond in technical and people matters, including performance goals and appraisals, and lead the QA organization through your leadership team, with overall accountability for people matters and disciplinary responsibility for QA associates.
Review and approve SOPs and work instructions within your functional responsibilities.
Assess and approve deviations and final investigation reports, getting to the heart of every issue.
Assess and approve trend reports and PQRs, and define the right actions.
Keep the site inspection-ready at all times and take the lead in Health Authority, regulatory compliance and customer inspections and audits, including as Sub Process Execution Owner for External Inspections.
Define, monitor and deliver meaningful quality metrics and targets, and drive continuous improvement.
Supervise training and invest in the training, coaching and development of your employees.
Act as a trusted advisor to site and JSC management, proactively flagging potential or actual developments that could adversely affect products or the business.
Foster a high-performance culture and build tomorrow's leaders through training and development, targeted assignments, career planning and succession planning.
What you bring
A 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.
Strong knowledge of FDA/EMA regulatory requirements for biologics or pharmaceuticals, and the ability to apply cGMP regulations and other FDA and international guidelines to all aspects of the position.
Experience in sterile manufacturing.
Excellent verbal and written communication skills in English, German is a plus.
Collaborative, cross-functional mindset and the ability to build strong partnerships with internal and external stakeholders, working effectively across Quality, Manufacturing, Supply Chain and Regulatory teams and sites.
Excellent computer proficiency (e.g. MS Office, SAP), combined with curiosity about and openness to AI and digital tools, and the ability to apply them responsibly to improve quality processes, data insights and decision-making.
Sharp analytical skills to identify gaps and root causes and to develop creative, practical solutions.
The ability to work independently, deliver under tight deadlines and bring a positive, solution-oriented attitude.
Does this sound like you? Join a diverse and inclusive team that is passionate about quality and about making a difference for patients. We welcome applications from all qualified candidates – apply today and help shape the future of Quality at Cilag AG.
Required Skills
Preferred Skills
