Senior Manager - Qualitätssicherung – Parenteral (m/w/d)

Eli Lilly Eli Lilly · Pharma · Alzey, Germany

Senior Manager of Quality Assurance for Parenteral production at a new high-tech pharmaceutical manufacturing site in Alzey, Germany. The role involves leading the operational QA organization, supporting the startup and routine operation of the facility, overseeing quality aspects, and developing a strong quality culture. Responsibilities include managing a team, ensuring compliance with cGMP regulations, and collaborating with cross-functional teams.

What you'd actually do

  1. As Senior Manager Quality Assurance (QA) – Parenteral (PAR), you will lead the operational QA organization, providing daily oversight, support, and guidance to the shopfloor quality and process team in the following production areas: Material/device preparation and formulation, aseptic filling and visual inspection.
  2. In this role: You will support the launch and routine operation of the QA organization for parenteral production at Lilly's new high-tech pharmaceutical production site in Alzey, Germany.
  3. Initially, you will take on the role of QA representative to support commissioning and qualification (C&Q).
  4. You will be responsible for quality oversight, including document releases (e.g., C&Q and validation documents, work instructions) and cross-functional decision-making.
  5. You will develop into a leadership role for GMP routine operations, shape "Shopfloor Quality" programs, build a solid training framework for QA employees, and take on the technical and administrative leadership of the Shopfloor Quality Team.

Skills

Required

  • Bachelor's degree in science, engineering, or a pharmaceutical-related field or equivalent experience.
  • Minimum of 5 years of leadership experience in the pharmaceutical industry with specific QA experience, including leading or effectively collaborating with cross-functional teams.
  • Demonstrated understanding of cGMP regulations and Quality Management Systems: Knowledge of cGMP practices including good documentation practices,

What the JD emphasized

  • cGMP regulations
  • Quality Management Systems
  • cGMP practices
  • good documentation practices