Local Quality Owner

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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:

Professional

All Job Posting Locations:

Schaffhausen Switzerland

Job Description:

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 .

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.

Cilag AG in Schaffhausen Switzerland is part of the Johnson & Johnson Innovative Medicine (J&J IM) Supply Chain organization and is currently recruiting for a

Local Quality Owner Late Stage & Value Optimizer (f/m/d) 80-100%

We manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and accelerating growth in parenterals supported by an impressive pipeline of new and innovative products.

Position summary

The function holder is responsible for the QA oversight of a selected Portfolio of established (Combination-) Products which are manufactured at the J&J IM Schaffhausen site.

Principal responsibilities

• Key Contact for internal and external stakeholders (operations planning logistics engineering regulatory affairs etc.) within cross-functional teams in terms of Quality and Compliance.
• Q&C contributions including Decision making and problem solving and oversight of assigned established manufacturing lines.
• Investigation lead for major non-conformances (deviations) including CAPA alignment with Operations counterparts.
• In-time release of parenteral products (intermediate and finished products).
• Proactive risk mitigation.
• Review and approval of non-conformances (deviations) records and change requests.
• Review and approval of GMP critical SAP master data (e. g. bill of material manufacturing instructions etc.).
• Review and approval of work instructions and standard operating procedures.
• Support of cross-functional and global projects.
• Review of Annual Product Reviews.

Qualifications

• A minimum of a Bachelors degree preferably in a technical/scientific field. A Masters degree or advanced is desirable.
• Minimum of 5 years of experience in a GMP regulated Pharma production environment or in a relevant quality or supply chain role.
• Strong understanding of parenteral fill/finish manufacturing incl. device assembly and packaging processes.
• In-depth knowledge in GMP standards policies and procedures
• Knowledge about regulatory guidelines preferred
• Advanced communication skills verbal and written in both English and German

We are looking for a dynamic and solution-oriented individual eager to contribute to our team and drive success in a collaborative international and fast-paced environment. If you see yourself in this role we encourage you to share your application materials with us without hesitation.

Required Skills:

Preferred Skills:

Business Alignment Business Savvy Coaching Communication Compliance Management Continuous Improvement Fact-Based Decision Making Human-Centered Design ISO 9001 Issue Escalation Problem Solving Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment Standard Operating Procedure (SOP)
Employment Type : Full-Time
Experience: years
Vacancy: 1