QA Lead: Late-Stage Parenteral Manufacturing & Compliance

Johnson & Johnson; Schaffhausen; On-site; CHF 120,000 - 170,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

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

Quality Management Systems

Quality Standards

Regulatory Environment

Standard Operating Procedure

Education

Bachelor’s degree

Master’s degree

Job description

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