Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson and is currently recruiting for a
Senior Manager Quality Assurance Small Molecules (f/m/d), 80-100%
We manufacture 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.
The function holder is with his teams responsible for the Quality Oversight of Small Molecule manufacturing (API and Drug Product) at the JSC Schaffhausen site reporting directly to the Site Quality Head. Besides being a member of the Site Quality Leadership team, the function also reports dotted line to the Vice President Janssen Supply Chain Quality for Small Molecules and is a part of the Janssen SM Quality Platform leadership team representing the Schaffhausen SM site.
Prime Objective is to ensure that products comply with applicable standards and have been manufactured and released according to cGMP. This includes a range of different Small Molecule APIs, precursors for Medical Devices and Drug Products supporting sales of more than 4 billion dollars.
Strategies have to be established and implemented to ensure that the Quality Systems consistently complies with the Johnson & Johnson Policies and global/regional standards of Johnson & Johnson and applicable regulatory requirements (ICH, EudraLex - Volume 4 – GMPs, US FDA, GDP, Pharmacopoeias, etc.) in order to ensure and maintain the quality and compliance of products used in the Janssen Supply Chain and by third party customers throughout the distribution chain and life cycle of the products.
- Drive a culture of proactive quality and continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.
- Functions as the link of JSC Schaffhausen with the Small Molecules Quality platform of Janssen as a member of the Janssen Small Molecules Quality platform leadership team
- Follow up on management indicators and results.
- Ensure management and closure of non-conformance records, change control records and corrective / preventive actions.
- Guide, train, evaluate and develop the personnel in charge.
- Provide guidance and direction on Quality investigations to different areas.
- Escalation Lead for significant Quality investigations
- Provide information analysis and guidance to site and JSC management in projects with GxP impact, ensuring adequate communication of needs and quality status & compliance to all areas affected.
- Act as an expert in quality and compliance in the inter-functional groups of the company.
- Ensure that the Business unit is ready to receive audits or GxP inspections.
- Lead audits and GxP inspections as e.g. Swissmedic or other HA inspections
- Evaluate the results of management reviews, audits, etc., and govern the implementation of corrective actions.
- Evaluate quality performance indicators and lead the implementation of the actions required for continuous improvement.
- Prepare and manage the budget of the area ensuring good control and use of resources.
- Provide guidance and training to quality personnel according to the company's organizational and policy objectives.
- Ensure alignment and benchmarking with other JSC manufacturing sites
SCOPE AND LIMITS OF ACTION
- Make decisions and support resolution of problems in all aspects of quality oversight in Small Molecules Manufacturing.
- 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.
- Determine the needs for the elaboration of procedures related to the activities of the area.
- Preparation/approvals of reports and tasks generated in the area
- Resolution of non-conformities that put at risk the quality of a product or the customer.
- Establishment of Strategies in the area.
- Authorization of the annual work plan.
- Authorization of strategies for the implementation of new regulatory, regional or corporate requirements.
- Request for material and human resources for the area.
- The person is a member or has meetings and agreements with higher hierarchical levels such as:
- Site Quality Leadership Team (Member)
- Janssen Small Molecules Platform Quality Leadership Team (Member)
- Site Management Board
- Site Quality Heads of other Janssen Small Molecules sites in the platform
- Managers and / or area supervisors, Directors and / or Quality Managers of J&J affiliates, Q&C functions and external customers
Keep them informed on relevant quality issues and to effectively and timely disclose changes or new corporate or regional regulatory requirements regarding Good Manufacturing Practices issued by Health Authorities or by Johnson & Johnson all activities involved with quality assurance
Quality and compliance issues of the products manufactured, as well as action plans to mitigate or avoid risks associated with the quality of the product and other activities involved with quality assurance
• 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 an API or Drug Product supply chain in Operations or Quality Operations.
• Strong understanding of manufacturing, analytics, quality, compliance and knowledge of local & global regulatory requirements
• Experienced in leading and coordinating regulatory inspections and customer audits
• 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
• Knowledge of statistics and process excellence tools
• Ability to influence and negotiate across the organization at all levels.
• Leadership imperatives
o Connect with Business Partners, Stakeholders and Customers
o Shape: shape changes to support continues improvement
o Lead: create an environment in which the quality and compliance culture is considered the key for success (right to sell)
o Deliver: Deliver results by inspiring and mobilizing people and cross functional teams
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, CV and ideally testimonials.