Compliance & Continuous Improvement Director (Operations) - All Genders

Role Summary (F/M)
The Compliance & Continuous Improvement Director (Operations) reports to the Site head and works closely with the VP Quality. He is responsible for embedding GMP execution discipline, lean practices, and digital maturity within Operations during the GMP site launch and ramp-up so as to support the Quality team.

Beyond the launch, the role will transform into a permanent driver of compliance discipline and continuous improvement, ensuring Operations maintain inspection readiness, sustain lean practices, and continuously improve efficiency and robustness as the site scales up.

This position is therefore critical not only to secure readiness in the short term, but also to guarantee long-term operational maturity, compliance resilience, and cultural transformation within the site.

Key Responsibilities - Evolution of the Role

Phase 1 - Site Launch and GMP Ramp-Up
- Ensure_ Operations_ deliver on GMP readiness milestones (validation packages, training completion, documentation, inspection preparation) in partnership with the QA team so as to accelerate the readiness.
- Close compliance gaps and embed execution routines (deviations, CAPA, Change Control, training).
- Coordinate with QA to prepare for regulatory inspections and audits, ensuring processes and teams are ready.
- Install tiered governance, dashboards, KPIs, and escalation routines within Operations.

Phase 2 - Transition to Steady-State Operations
- Sustain compliance routines across Operations, ensuring timely closure of quality actions and robust documentation practices.
- Reinforce accountability of Operations teams for GMP deliverables, reducing reliance on QA support.
- Strengthen digital maturity (MES, PI, DeltaV, LIMS, eQMS) and ensure operational use is fully compliant.
- Consolidate lean management practices and drive simplification of processes to improve efficiency and robustness.

Phase 3 - Continuous Improvement and Site Maturity
- Act as a permanent anchor for operational excellence in compliance, efficiency, and digital transformation.
- Ensure continuous inspection readiness, embedding a proactive compliance mindset within Operations.
- Lead site-wide initiatives to improve efficiency, reduce waste, and foster a culture of structured problem solving (DMAIC, Kaizen, standard work).
- Partner with QA and other site functions to strengthen long-term compliance resilience and operational performance.
- Serve as a trusted advisor to the Site Head, able to represent Operations compliance externally and rally teams around performance and accountability.

Qualifications & Experience
- Advanced degree in Life Sciences, Engineering, or Pharmacy.
- 10+ years in biopharma operations, manufacturing, MSAT, or compliance, ideally in GMP site launches or transformations.
- Strong knowledge of EU GMP, ICH, Annex 1/15, inspection readiness requirements.
- Proven experience with validation, qualification, and GMP readiness deliverables.
- Familiarity with digital GxP systems (MES, PI, DeltaV, LIMS, eQMS).
- Demonstrated leadership in lean deployment and continuous improvement programs.
- Lean Six Sigma Green Belt or Black Belt certification appreciated.
- Fluent in English and French.

Success Profile
- Pragmatic and hands-on leader who thrives in GMP launch environments and can guide the transition to maturity.
- Trusted partner to QA, ensuring collaboration while securing Ops ownership of compliance.
- Recognized change agent, compliance-driven and efficiency-oriented.
- Strong operational leader, capable of reinforcing accountability and building a high-performing Operations organization.