Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson and is currently recruiting for a
Senior Manager QA Lab & Release (f/m/d), 80-100%
We manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all 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.
The function holder is leading the leaders of several teams in Quality Assurance in regards to Quality and Compliance aspects of batch release testing (QA Lab), AQL testing and final packaging control (AQL & VEK) as well as batch record review, release, restriction management and certificates (Review & CofA). This function reports directly to the Director QA Parenterals and is part of the QA Parenterals Leadership Team.
Prime Objective is to ensure that products comply with applicable standards and have been manufactured, tested and released according to cGMP. This includes a wide range of products in pre-filled syringes and vials, including some of the largest brands of the Janssen Supply Chain.
- Drive a culture of proactive quality and continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.
- Guide, train, evaluate and develop the personnel in charge.
- Provide information analysis and guidance to Quality and Site management in projects with GxP impact, ensuring adequate communication of needs and quality status & compliance to all areas affected.
- Evaluate quality performance indicators and lead the implementation of the actions required for continuous improvement.
- Ensure alignment and benchmarking with other JSC manufacturing sites.
- Ensure Quality Assurance and Compliance aspects of several large QC Labs on site with over 150’000 tests completed per year.
- Lead the teams for Acceptable Quality Level (AQL) and packaging end control (VEK) to ensure clinical and commercial supply of products in the desired quality.
- Ensure Quality and Compliance aspects and lead the teams for batch record review, batch disposition and release as well as restriction management based on regulatory information and creation of certificates of analysis.
SCOPE AND LIMITS OF ACTION
- Make decisions and support resolution of problems in all Q&C aspects of the respective areas.
- Assignment of tasks and delegation of responsibilities to the group, in accordance with the provisions of the work plan and the needs of the area.
- Establishment of Strategies in the area and for the implementation of new regulatory, regional or corporate requirements.
- Request for material and human resources for the area.
- A minimum of a Bachelor’s degree is required with a major or concentration in one of the following: Chemistry, Pharmacy, Biochemistry, Engineering, or a similar technical/scientific degree. A Master’s degree or advanced is desirable.
- Minimum 5 years in a leadership role within Drug Product supply chain in Operations or Quality Operations.
- Strong understanding of manufacturing, analytics, quality, compliance and knowledge of local & global regulatory requirements
- Ability to operate in a global matrix organization with multiple stakeholders
- Excellent communication skills, verbal and written in both English and German
- Flexible, motivated and solution-oriented team player
- In-depth knowledge in GMP standards, policies and procedures
- Strong decision making and problem-solving competencies
- Knowledge of administration and personnel management.
- Sound knowledge about implementation and optimization of quality systems and processes
We are offering you a challenge in a dynamic, international environment with attractive terms and career opportunities.
If you are interested in this position, then please apply online including application letter and CV.