Head QA Operations

Department Info

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.

Job Summary

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 

Job Responsibilities

·  Provide technical and managerial leadership to the QA Operations sub‑department, including the QA Operations and QA Qualification & Validation teams (currently 7 associates; teams expected to grow).

·  Ensure effective execution and governance of core QMS processes, including deviations, CAPAs, change control, OOX investigations, and risk assessments.

·  Ensure QA oversight over operational units including Manufacturing, Engineering, Supply Chain Management, and Quality Control.

·  Review, create, and approve GMP documentation, including SOPs and related records, as required.

·  Ensure GMP‑compliant handling of processes within the QA Operations sub‑department.

·  Support and promote company‑wide GMP compliance.

·  Ensure risk assessments are performed adequately, consistently, and in a timely manner.

·  Ensure that required qualifications and validations are appropriately planned, executed, reviewed, and maintained.

·  Support regulatory inspections, customer audits, internal audits, and self‑inspections.

·  Perform audits and self‑inspections as required.

·  Act as a primary Quality contact person for customers regarding quality matters related to their products.

·  Support QA‑related, site‑wide, and cross‑functional projects as needed.

·  Coach, develop, and mentor associates within the QA Operations organization.

·  Collaborate cross‑functionally with Manufacturing, Engineering, QC, Supply Chain, IT, and other stakeholders.

·  Identify and drive continuous improvement opportunities within QA Operations and related processes.

·  Ensure clear communication, structured decision‑making, and timely escalation of quality‑related issues.

·  Act as a role model for the highest quality standards and for Terumo values and culture.

·  Perform additional duties as assigned by 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

A senior Quality leadership role within a growing EMEA QARA Team that supports the CDMO organization at Terumo’s Leverkusen site.
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