Our client is a fast-growing and innovative biotech company, active in the development of biological products with high medical value, operating in an international environment.
As its clinical development activities expand, the company is strengthening its organization and is looking for a Clinical Quality Assurance Manager to ensure the highest level of quality, compliance and permanent inspection readiness across its clinical programs.
Responsabilities
Reporting to the Quality Assurance Director and working hands in hands with the clinical department, you are responsible for defining, implementing and overseeing the Clinical Quality Assurance strategy, ensuring subject safety, data integrity and compliance with applicable regulations.
Your key responsibilities are:
- Ensure continuous inspection readiness of the organization through proactive quality oversight and anticipation of regulatory expectations.
- Set up a risk-focused oversight model covering clinical studies and external partners, including audits, follow-up actions and continuous monitoring.
- Design and deploy a pragmatic, risk-based Clinical Quality Assurance framework, adaptable to development stages and aligned with ICH-GCP principles and relevant regulatory standards.
- Structure, maintain and adapt the Clinical Quality System, in close collaboration with the Clinical Development Director.
- Stay abreast of regulatory trends impacting clinical development and translate them into practical guidance, training and fit-for-purpose quality tools
- Act as a key quality partner to clinical teams, CROs and external stakeholders, facilitating clear communication and timely escalation when needed.
Profile
- Master’s degree or equivalent in Life Sciences or Pharmacy.
- 5 years of experience in the (bio)pharmaceutical industry, with strong exposure to Clinical QA and/or Clinical Operations,
- Proven experience as a GCP Auditor and/or significant involvement in audits and inspections.
- Strong knowledge of regulations related to clinical trials.
- Fluent French and English, written and spoken (negotiation level).
- Detail-oriented and action-focused profile, comfortable working independently in dynamic environments, with solid analytical thinking, effective communication skills and a strong team mindset.
Offer
- A key leadership role within an innovative and growing biotech environment.
- High level of autonomy and visibility, working closely with senior management.
- International scope and challenging clinical development programs.
- Attractive compensation package aligned with experience and responsibilities.
Your application will be treated with the utmost confidentiality, in accordance with the GDPR. PaHRtners promotes diversity, equity, and inclusion.