Local Quality Owner

Johnson & Johnson seeks a Local Quality Owner in Schaffhausen to oversee QA for established combination products, ensuring compliance, release, and risk mitigation in a GMP-regulated environment.

The company is looking for a professional to manage quality assurance for a specific portfolio of established combination products manufactured at its Schaffhausen facility. This position focuses on providing oversight for assigned manufacturing lines, ensuring timely product release, and leading investigations into major non-conformances.

Responsibilities

• Serve as the primary point of contact for internal and external stakeholders, including operations, planning, logistics, engineering, and regulatory affairs, regarding quality and compliance matters within cross-functional teams.
• Provide quality and compliance input, including decision-making and problem-solving, while overseeing assigned, established manufacturing lines.
• Lead investigations for major non-conformances (deviations) and align corrective and preventive actions (CAPA) with operations counterparts.
• Ensure the timely release of parenteral products, including both intermediate and finished goods.
• Proactively identify and mitigate risks.
• Review and approve non-conformance (deviation) records and change requests.
• Review and approve GMP-critical SAP master data, such as bills of material and manufacturing instructions.
• Review and approve work instructions and standard operating procedures.
• Support cross-functional and global projects.
• Review Annual Product Reviews.

Requirements

• A minimum of a Bachelor’s degree, preferably in a technical or scientific field.
• Minimum of 5 years of experience in a GMP-regulated pharmaceutical production environment or in a relevant quality or supply chain role.
• Strong understanding of parenteral fill/finish manufacturing, including device assembly and packaging processes.
• In-depth knowledge of GMP standards, policies, and procedures.
• Advanced communication skills, verbal and written, in both English and German.

Nice to have

• A Master’s degree or advanced degree is desirable.
• Knowledge of regulatory guidelines is preferred.

About the company

Johnson & Johnson fosters an inclusive work environment where every individual is valued. The company respects the diversity and dignity of its employees and recognizes their merit.

• An inclusive work environment where each person is considered as an individual.
• Respect for the diversity and dignity of employees, with recognition of their merit.