Director QA Operations

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

Director Quality Assurance (QA)

Cilag AG, a Johnson & Johnson company, Schaffhausen

Lead Quality where it truly matters – for patients. Ready for a leadership role with real impact? As Director QA at Cilag AG, a Johnson & Johnson company, you will head our Quality Assurance (QA) department and play a key part in making sure that high-quality products reach the patients who depend on them. As a trusted partner within the wider Quality organization, you will shape how we manufacture and release our products according to cGMP, and you will organize and lead QA within the Quality matrix framework and in line with internal and external regulations, policies and international regulatory requirements. If you want to inspire a strong team, work at the forefront of quality and make a visible difference, this is your opportunity.

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: