Job Description:

Johnson and Johnson Innovative Medicine (Cilag AG) is recruiting for a Senior Manager QA Products Parenterals (Value Optimizer and Late Stage), located in Schaffhausen, Switzerland.

The function holder is managing a team of Quality Product Owners (Local Quality Owners), reports to the Director QA Parenterals and is part of the QA Parenterals Leadership team. The position holder is responsible for all Quality & Compliance aspects of high-value parenteral products in regards of manufacturing and packaging.

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 Johnson & Johnson Innovative Medicine.

Key Responsibilities:

• Ensure that Quality standards are reliably maintained and comply with J&J global guidelines and regulatory expectations and provide quality and compliance guidance and leadership for a large portfolio of parenteral products.

• Assessment of criticality, initiation of investigations, assessment of the investigation results and defined corrective actions, close out of investigations and tracking of corrective actions.

• Review and approval of GMP relevant documentation, initiate quality escalations and lead escalation meetings, ensure permanent inspection readiness state and act as lead in J&J internal and external regulatory inspections.

• Lead the Local Quality Owner team including driving talent development, conduct performance reviews and ensuring sufficient and appropriately trained QA resources within QA Products Parenterals.

Qualifications

Education:

• University degree at a master level in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology or engineering.

Experience and Skills:

Required:

• A minimum of 5 years experience in quality functions in pharmaceutical or medical device companies including people leadership responsibility.

• In-depth knowledge of current Quality Management principles, GMP and Quality Systems and Pharmaceutical regulations (PIC/S, ICH, FDA guidelines, Eudralex, etc.)

• Excellent written and oral communication skills in German and English.

• Team player, and ready to take a stand when necessary.

• Must be able to work independently with minimum supervision to meet tight deadlines while maintaining a positive attitude.

Preferred:

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

• Computer proficiency e.g. MS Office, SAP, eLIMS, Salesforce.

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop solutions.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: