" Caring for the world…one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson pharmaceutical companies operating under the “ Janssen Pharmaceutical Companies of Johnson & Johnson” trademark and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices.
Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.
Senior Manager Quality Control Biotech (m/f)
The Quality Control Biotech department is responsible for testing of the Company’s biotech products.
As a member of the site quality control leadership team you will be expected to provide proactive support to the Site Quality Control Head in improving the organizational capabilities and processes of the site quality control organization and to work on regional / global projects in support of the supply chain network. The role provides an excellent opportunity for further career and technical development within Johnson and Johnson.
- Responsible for short and long term goals of quality control (QC) laboratory efforts in support of NDA and commercial products.
- Responsible for method transfers to routine use including adaption of all related quality systems and participation of QC staff in support of validation of methods and qualification of equipment
- Responsible for testing of biopharmaceutical drug products, QC inspections and auditing of these drug products.
- Manage staff of Quality Control Biotech department ensuring timely product disposition: release and stability testing, in-process testing, QC documentation, equipment maintenance and calibration and QC laboratory design and maintenance
- Ensure compliance to regulatory requirements
- Ensure Safety and Quality standards are reliably maintained and comply with J&J global guidelines and regulatory expectation.
- Develops departmental budget for quality assurance and quality control, including defining materials, equipment and personnel needs.
- Drive continuous improvement.
- Responsibility for training, development and performance of all Quality Control Biotech associates.
- Establishes and directs QC control programs and GMP training programs. Reviews and approves quality reports and GMP documentation
- Lead proactive succession planning and a high performance culture through people training and development, targeted assignments and career planning.
- Engage in sector and corporate initiatives.
- Member of the Site Quality Control leadership team.
This position requires
- Strong partnering and negotiating with multiple internal and external stakeholders.
- Demonstrated leadership skills and achievements in health care manufacturing industry with leadership responsibility in a significant laboratory function.
- A strong scientific leader with a clear understanding of regulatory expectations related to biopharmaceutical products.
- Knowledge of recombinant protein expression and purification as well as in protein chemistry and analytical biochemistry.
- Ability to hire, develop and retain top talent for QC operations.
- Exposure to an international working environment in previous roles is preferred.
- Regulatory and inspection experience is preferred.
- Broad business acumen, including insight in End-to-End supply chain characteristics is preferred.
- Excellent written and oral communication skills in English and German.
- A Master’s or PhD degree or equivalent in a scientific discipline.
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and an excellent infrastructure. If you feel attractedby this challenge and want to be part of a successful and growing organization, then please send us your online application.
Cilag AG (8562)