Local Quality Owner

Johnson & Johnson AG; Schaffhausen; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Cilag AG in Schaffhausen, Switzerland, part of Johnson & Johnson Innovative Medicine, seeks a Local Quality Owner for late-stage products. The role ensures QA oversight of a portfolio of established products manufactured at the Schaffhausen site, coordinating with operations, regulatory affairs, and global teams.

You will lead investigations, CAPA alignment, and the in‑time release of parenteral products, while driving risk mitigation and continuous improvement in a fast‑paced, international

Qualifikationen

• Bachelor’s degree in a technical or scientific field; Master’s degree desirable.
• Minimum 5 years in a GMP regulated pharma production or quality/supply chain role.
• Strong understanding of parenteral fill/finish, device assembly and packaging.
• In‑depth knowledge of GMP standards, policies and procedures.
• English and German language skills required.

Aufgaben

• Key contact for internal and external stakeholders on Quality and Compliance within cross‑functional teams.
• Q&C contributions including decision making and oversight of assigned manufacturing lines.
• Investigation lead for major non‑conformances with CAPA alignment with Operations.
• In‑time release of parenteral products (intermediate and finished).
• Proactive risk mitigation and review/approval of deviations and change requests.
• Review and approval of GMP critical SAP master data and SOPs.
• Support cross‑functional and global projects; review Annual Product Reviews.

Kenntnisse

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

Quality Management Systems

Quality Standards

Regulatory Environment

Standard Operating Procedure

Ausbildung

Bachelor’s degree

Master’s degree

Jobbeschreibung

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

Location: Schaffhausen, Switzerland

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 role focused on QA oversight of a selected portfolio of established (Combination-) Products manufactured at the J&J IM Schaffhausen site.

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 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.

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: 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)