Local Quality Owner Late Stage & Value Optimizer (f/m/d)
Job Function: Quality | Job Sub Function: Quality Assurance | Job Category: Professional Location: Schaffhausen, Switzerland Position Summary
Johnson & Johnson (Cilag AG) is recruiting for the Local Quality Owner Late Stage & Value Optimizer role. The holder of this position will provide QA oversight of a selected portfolio of established (Combination‑) products manufactured at the J&J IM Schaffhausen site. Key Responsibilities
Key contact for internal and external stakeholders (operations, planning, logistics, engineering, regulatory affairs, etc.) within cross‑functional teams regarding Quality and Compliance. Provide Quality & Compliance contributions, including decision making, problem solving and oversight of assigned, established manufacturing lines. Lead investigations of major non‑conformances (deviations) and align CAPA actions with Operations counterparts. Ensure in‑time release of parenteral products (intermediate and finished products). Implement proactive risk mitigation strategies. Review and approve non‑conformance (deviation) records and change requests. Review and approve GMP critical SAP master data (e.g., bill of material, manufacturing instructions). Review and approve work instructions and standard operating procedures. Support cross‑functional and global projects. Review Annual Product Reviews. Qualifications
Minimum of a Bachelor’s degree, preferably in a technical or scientific field. Master’s degree or advanced qualification 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, including device assembly and packaging processes. In‑depth knowledge of GMP standards, policies and procedures. Knowledge of regulatory guidelines preferred. Advanced communication skills, both verbal and written, in English and German. Dynamic and solution‑oriented individual eager to contribute to a collaborative, international, fast‑paced environment. Preferred Skills
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, Human‑Centered Design, ISO9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP). Johnson & Johnson is committed to an inclusive work environment that respects diversity and dignity.
#J-18808-Ljbffr
Job Function: Quality | Job Sub Function: Quality Assurance | Job Category: Professional Location: Schaffhausen, Switzerland Position Summary
Johnson & Johnson (Cilag AG) is recruiting for the Local Quality Owner Late Stage & Value Optimizer role. The holder of this position will provide QA oversight of a selected portfolio of established (Combination‑) products manufactured at the J&J IM Schaffhausen site. Key Responsibilities
Key contact for internal and external stakeholders (operations, planning, logistics, engineering, regulatory affairs, etc.) within cross‑functional teams regarding Quality and Compliance. Provide Quality & Compliance contributions, including decision making, problem solving and oversight of assigned, established manufacturing lines. Lead investigations of major non‑conformances (deviations) and align CAPA actions with Operations counterparts. Ensure in‑time release of parenteral products (intermediate and finished products). Implement proactive risk mitigation strategies. Review and approve non‑conformance (deviation) records and change requests. Review and approve GMP critical SAP master data (e.g., bill of material, manufacturing instructions). Review and approve work instructions and standard operating procedures. Support cross‑functional and global projects. Review Annual Product Reviews. Qualifications
Minimum of a Bachelor’s degree, preferably in a technical or scientific field. Master’s degree or advanced qualification 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, including device assembly and packaging processes. In‑depth knowledge of GMP standards, policies and procedures. Knowledge of regulatory guidelines preferred. Advanced communication skills, both verbal and written, in English and German. Dynamic and solution‑oriented individual eager to contribute to a collaborative, international, fast‑paced environment. Preferred Skills
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, Human‑Centered Design, ISO9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP). Johnson & Johnson is committed to an inclusive work environment that respects diversity and dignity.
#J-18808-Ljbffr
Local Quality Owner Arbeitgeber: 8562-Cilag AG Legal Entity
Cilag AG in Schaffhausen bietet eine herausragende Arbeitsumgebung, die auf Qualität und Compliance fokussiert ist. Unsere Unternehmenskultur fördert Teamarbeit und kontinuierliche Weiterbildung, sodass Mitarbeiter in ihrer Karriere wachsen können. Zudem profitieren Sie von einem attraktiven Standort in der malerischen Schweiz, der sowohl berufliche als auch persönliche Lebensqualität vereint.
Kontaktdaten:
8562-Cilag AG Legal Entity Recruiting-Team
