Local Quality Owner Late Stage & Value Optimizer (f/m/d) – 80‑100% Location: Schaffhausen, Switzerland
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, 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 Bachelor’s degree, preferably in a technical/scientific field. A Master’s 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.
Required 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)
Preferred Skills
Business Alignment
Business Savvy
Coaching
#J-18808-Ljbffr
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, 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 Bachelor’s degree, preferably in a technical/scientific field. A Master’s 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.
Required 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)
Preferred Skills
Business Alignment
Business Savvy
Coaching
#J-18808-Ljbffr
Local Quality Owner Arbeitgeber: Johnson & Johnson Innovative Medicine
Johnson & Johnson ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Allschwil, Schweiz, eine inspirierende Arbeitsumgebung bietet, in der Innovation und Teamarbeit im Mittelpunkt stehen. Mit einem starken Fokus auf persönliche Entwicklung und einer Kultur der kontinuierlichen Verbesserung fördert das Unternehmen die berufliche Entfaltung seiner Mitarbeiter durch umfassende Schulungs- und Aufstiegsmöglichkeiten. Darüber hinaus profitieren die Mitarbeiter von wettbewerbsfähigen Vergütungen und umfangreichen Sozialleistungen, die ihre Lebensqualität unterstützen und ihnen helfen, einen positiven Einfluss auf die Gesundheit der Menschen weltweit zu haben.
Kontaktdaten:
Johnson & Johnson Innovative Medicine Recruiting-Team
