Head QA Operations

Job Category:
Quality & Regulatory Affaire

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.

Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for.

Terumo Pharmaceutical Services (PSD) is strengthening its Quality organization at its CDMO site in Germany. We are looking for a Head of QA Operations to lead QA oversight of GMP operations across the site and to ensure sustainable GMP compliance and inspection readiness.

Reporting to the Head of Quality, the Head of QA Operations is responsible for QA oversight and GMP compliance of manufacturing, engineering, supply chain, and quality control activities. The role ensures compliant execution of GMP‑relevant processes such as deviations, CAPAs, change control, OOX investigations, and risk assessments, while leading and developing the QA Operations organization.

What You’ll Be Responsible For:

• Lead and grow the QA Operations organization, providing both technical and people leadership to the QA Operations and QA Qualification & Validation teams (currently 7 associates, with planned expansion).
• Own and drive excellence in core QMS processes, ensuring robust governance and execution of deviations, CAPAs, change controls, OOX investigations, and risk management activities.
• Provide strong QA oversight across Manufacturing, Engineering, Supply Chain Management, and Quality Control to ensure compliant and efficient operations.
• Champion GMP excellence, reviewing, creating, and approving SOPs and related documentation while ensuring all QA Operations processes are inspection‑ready at all times.
• Ensure timely and effective risk assessments, qualifications, and validations—planned, executed, reviewed, and maintained to the highest standards.
• Serve as a key quality representative during regulatory inspections, customer audits, internal audits, and self‑inspections—and personally conduct audits when required.
• Act as the primary Quality contact for customers, building trust and ensuring quality matters related to their products are managed with transparency and professionalism.
• Drive continuous improvement, identifying opportunities to strengthen QA Operations processes and enhance overall site quality performance.
• Foster cross‑functional collaboration, working closely with Manufacturing, Engineering, QC, Supply Chain, IT, and other stakeholders to achieve shared quality goals.
• Coach, mentor, and develop your team, building capabilities and cultivating a culture of accountability, engagement, and growth.
• Promote structured decision‑making and clear communication, ensuring timely escalation and resolution of quality‑related issues.
• Lead by example, embodying the highest quality standards and living Terumo’s values and culture.
• Contribute to site‑wide and cross‑functional projects, and take on additional responsibilities as needed in partnership with the Head of Quality.

• Advanced degree (Bachelor, Master, or PhD) in pharmacy, biochemistry, biotechnology, or a related scientific discipline.
• Minimum 8 years of experience working in a GMP‑regulated environment, including several years in Quality Assurance.
• Several years of relevant managerial and people‑leadership experience.
• Thorough knowledge of pharmaceutical cGMP requirements.
• Detailed knowledge of Quality Management System processes.
• Strong understanding of biopharmaceutical manufacturing processes and quality control.
• Experience with QA‑relevant software systems (e.g. Track Wise, Master Control, Veeva or equivalent).
• Proven track record of successful audits and inspections, preferably including experience with US FDA inspections.
• Very strong leadership and people‑management skills.
• Very strong organizational and prioritization skills.
• Very strong communication and stakeholder‑management skills.
• Fluent in English;
  German language skills are preferred.

• A senior Quality…