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QA Compliance Manager and QP Deputy - Exothera
Company: Exothera
Location: Jumet Nova (UEXO)
Your Mission
At Exothera, we are committed to delivering excellence in advanced therapy manufacturing.
As a QA Compliance Manager, you will be at the heart of our Quality Operations, ensuring our processes meet the highest cGMP standards while enabling innovation and operational agility.
You will own and drive the implementation of state-of-the-art Quality Management Systems, ensure regulatory readiness, and oversee the release of raw materials and final products. In this role, you’ll act as a key partner across operations and quality teams, directly impacting our life-saving therapies' safety, quality, and compliance.
What You'll Do
Operational Quality Systems
Lead the design, implementation, and oversight of Exothera’s Operational QMS.
Own key quality processes: risk management, change control, deviations, CAPA, training, internal controls, and complaints.
Be the Business Owner of the eQMS platform.
Define, monitor, and drive quality performance metrics and support continuous improvement initiatives.
Animate and lead the Site Quality Council.
Ensure appropriate supplier qualification and performance follow-up.
Maintain and approve the site risk register.
Provide expert support to major investigations and regulatory impact assessments.
Ensure the site's continuous regulatory and audit readiness.
Product & Material Release
Ensure compliant release of raw materials and finished products based on GMP documentation, QC records, and regulatory authorizations.
Escalate any critical quality issues to the Qualified Person in a timely manner.
Regulatory Engagement
Act as a key stakeholder in Regulatory Inspections and Client Audits, ensuring full transparency, preparation, and documentation alignment.
What You Bring
Qualifications and Experience
Master’s Degree in Pharmacy (M.Sc), with QP aggregation required.
- Minimum 10 years of experience in biotechnology, cell & gene therapy, or pharma.
- Broad exposure to Quality Assurance and GMP manufacturing environments.
- Proven experience with product release under GMP framework.
Skills & Competencies
Strong leadership and influencing skills.
Deep knowledge of GMP regulations (EU & FDA, WHO a plus).
Proven ability to manage inspections and audits with confidence.
Excellent communication and cross-functional collaboration skills.
Fluency in English (French is a plus).
Agility, resilience, and a proactive mindset.
Why Join Us
At Exothera, you’ll find a fast-paced, mission-driven environment where quality meets innovation. You’ll play a vital role in shaping the future of bioproduction—while growing within a team that values excellence, learning, and impact.