Team Lead QA Operations

Terumo Europe NV; Leverkusen; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Leadership role in QA

Exposure to sterile manufacturing

Collaborative work environment

Competitive compensation

Occasional travel

Job summary

Terumo Europe NV in Leverkusen is seeking a Team Lead QA Operations to lead a team of QA professionals ensuring quality oversight across GMP manufacturing. The role partners with Operations and site functions to enable compliant and efficient manufacturing.

The ideal candidate has strong background in aseptic manufacturing, GMP standards (EMA/FDA), and experience with deviations, investigations, CAPAs, and transfers. This position is site-based with occasional travel.

Qualifications

• Bachelor's or Master's degree in a relevant scientific discipline
• 7+ years of experience in GMP-regulated pharma/biotech environments
• 3+ years in leadership/management roles
• Strong experience in QA Operations supporting manufacturing
• Experience in aseptic manufacturing and/or aseptic fill & finish operations
• Solid understanding of GMP and regulatory standards (EMA/FDA)
• Experience handling deviations, investigations, quality events and decision-making
• Experience with biological products, technology transfers, validation activities and GMP processes
• Knowledge of QA Operations, Manufacturing, QC, Warehousing and MSAT

Responsibilities

• Lead, coach, develop, and mentor the QA Operations team, with resource planning and performance management
• Provide QA oversight for GMP activities across Manufacturing, QC, MSAT, Warehousing, Supply Chain and Engineering
• Serve as primary quality partner for manufacturing operations and daily production activities
• Guide deviations, investigations, CAPAs, change controls, risk assessments and OOS/OOT investigations within QMS
• Support new product introductions, tech transfers, validation activities and continued process verification
• Review and approve GMP documentation, quality records, procedures and risk assessments
• Support internal audits, client audits, regulatory inspections and self-inspections
• Act as a quality representative for customers and participate in due diligence and visits
• Drive continuous improvement initiatives for compliance and efficiency
• Collaborate with Operations, Engineering, QC, MSAT, Supply Chain and other stakeholders on risk management
• Ensure timely communication and escalation of quality and compliance risks

Skills

Leadership

Quality Assurance Operations

Aseptic manufacturing

Cross-functional collaboration

Education

Bachelor's or Master's degree in Chemistry, Biochemistry, Microbiology, Biological Engineering, Pharmaceutical Sciences, or related field

Job description

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

Terumo Pharmaceutical Solutions (TPS), part of Terumo's Pharmaceutical Solutions Division (PSD), is a global Contract Development and Manufacturing Organization (CDMO) specializing in the development and manufacture of sterile injectable products for pharmaceutical and biotechnology customers worldwide.

Our manufacturing site in Leverkusen, Germany, plays a critical role in delivering high-quality pharmaceutical products in a highly regulated GMP environment.

Job Summary

As Team Lead QA Operations, you will lead and develop a team of QA professionals responsible for providing quality oversight across critical GMP manufacturing operations. You will act as a key quality partner to Operations and other site functions, ensuring compliant and efficient manufacturing while enabling business objectives.

This positionrequires strong technical expertise in aseptic manufacturing environments, sound quality judgement, and the ability to make informed decisions during complex operational situations.

You will play a key role in supporting manufacturing activities, product transfers, investigations, process improvements, customer interactions, audits, and regulatory inspections, while fostering a culture of quality, collaboration, and continuous improvement.

Job Responsibilities

As Team Lead QA Operations, you will:

• Lead, coach, develop and mentor the QA Operations team, ensuring effective resource planning, performance management, and capability development.
• Provide QA oversight for GMP activities within Manufacturing, Quality Control, Manufacturing Science & Technology (MSAT), Warehousing, Supply Chain and Engineering.
• Serve as the primary quality partner for manufacturing operations, supporting daily production activities and ensuring compliant decision-making.
• Provide guidance and oversight for deviations, investigations, CAPAs, change controls, risk assessments, OOS/OOT investigations, and other Quality Management System processes.
• Support new product introductions, technology transfers, validation activities, and continued process verification programs.
• Review and approve GMP documentation, quality records, procedures, risk assessments, and quality decisions within the assigned scope.
• Support internal audits, client audits, regulatory inspections, and self-inspections.
• Act as a quality representative for customers, supporting quality discussions, due diligence activities, and customer visits.
• Drive continuous improvement initiatives that strengthen compliance, efficiency, and operational excellence.
• Collaborate closely with Operations, Engineering, QC, MSAT, Supply Chain and other cross-functional stakeholders to ensure effective quality oversight and risk management.
• Ensure timely communication, structured decision-making, and appropriate escalation of quality and compliance risks.

Profile Description

We are looking for a seasoned Quality professional who combines strong leadership skills with extensive operational quality experience in aseptic pharmaceutical manufacturing environments.

Required Qualifications & Experience

• Bachelor's or Master's degree in Chemistry, Biochemistry, Microbiology, Biological Engineering, Pharmaceutical Sciences, or another relevant scientific discipline.
• Minimum 7 years of experience within a GMP-regulated pharmaceutical or biotechnology environment.
• At least 3 years of leadership, management, or team lead experience.
• Strong experience in Quality Assurance Operations supporting manufacturing environments.
• Demonstrated experience within aseptic manufacturing and/or aseptic fill & finish operations.
• Solid understanding of GMP requirements and international regulatory standards, including EMA and FDA expectations.
• Experience supporting manufacturing operations during deviations, investigations, quality events, and operational decision-making.
• Experience working with biological products, technology transfers, validation activities, and GMP production processes.
• Strong knowledge of QA Operations, Manufacturing, Quality Control, Warehousing, and Manufacturing Science & Technology (MSAT)

Offer

At Terumo, you will have the opportunity to make a meaningful impact on products that improve and save lives around the world.

We offer:

• A leadership role within the quality department ofa growing international pharmaceutical CDMO organization, that is currently expanding it's manufacturing capabilities.
• The opportunity to shape and develop a high-performing QA Operations team.
• Exposure to advanced sterile manufacturing technologies and customer-facing quality activities.
• A collaborative and inclusive work environment where quality and innovation go hand in hand.
• Competitive compensation and benefits package.
• The chance to work alongside highly skilled professionals committed to operational excellence and patient safety.

This position is primarily site-based in Leverkusen, reflecting the operational nature of the role. Occasional travel may be required to other Terumo locations.

Contact Person

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.