Head QA Operations
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
Department Info
Job Summary
Job Responsibilities
As our QA Operations Leader, you will play an important role in shaping and strengthening our Quality organization. You will combine tactical leadership with hands-on quality expertise to ensure the highest standards across our site.
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.
Profile Description
· 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. TrackWise, MasterControl, 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.
Offer
The opportunity to shape QA Operations and Quality culture during a critical integration and growth phase.
High visibility and impact, with close interaction across site leadership and global Quality stakeholders.
A collaborative, international working environment within Terumo’s Pharmaceutical Solutions Division.
A culture that values quality excellence, accountability, continuous improvement, and patient impact.
Contact Person
Jan Swinnen
Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.