Compliance & Continuous Improvement Director (Operations) - all genders

<p><span><b>Role Summary (F/M)</b><br/>The Compliance &amp; 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<b> within Operations</b> during the GMP site launch and ramp-up so as to support the Quality team.</span></p><p><span>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.</span><br/> </p><p><span>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.</span><br/> </p><p><span><b>Key Responsibilities – Evolution of the Role</b></span></p><p><span><b>Phase 1 – Site Launch and GMP Ramp-Up</b></span></p><ul><li><span>Ensure<i> Operations</i> deliver on GMP readiness milestones (validation packages, training completion, documentation, inspection preparation) in partnership with the QA team so as to accelerate the readiness.</span></li><li><span>Close compliance gaps and embed execution routines (deviations, CAPA, Change Control, training).</span></li><li><span>Coordinate with QA to prepare for regulatory inspections and audits, ensuring processes and teams are ready.</span></li><li><span>Install tiered governance, dashboards, KPIs, and escalation routines within Operations.</span></li></ul><p><span><b>Phase 2 – Transition to Steady-State Operations</b></span></p><ul><li><span>Sustain compliance routines across Operations, ensuring timely closure of quality actions and robust documentation practices.</span></li><li><span>Reinforce accountability of Operations teams for GMP deliverables, reducing reliance on QA support.</span></li><li><span>Strengthen digital maturity (MES, PI, DeltaV, LIMS, eQMS) and ensure operational use is fully compliant.</span></li><li><span>Consolidate lean management practices and drive simplification of processes to improve efficiency and robustness.</span></li></ul><p><span><b>Phase 3 – Continuous Improvement and Site Maturity</b></span></p><ul><li><span>Act as a permanent anchor for operational excellence in compliance, efficiency, and digital transformation.</span></li><li><span>Ensure continuous inspection readiness, embedding a proactive compliance mindset within Operations.</span></li><li><span>Lead site-wide initiatives to improve efficiency, reduce waste, and foster a culture of structured problem solving (DMAIC, Kaizen, standard work).</span></li><li><span>Partner with QA and other site functions to strengthen long-term compliance resilience and operational performance.</span></li><li><span>Serve as a trusted advisor to the Site Head, able to represent Operations compliance externally and rally teams around performance and accountability.</span></li></ul><p><span><b>Qualifications &amp; Experience</b></span></p><ul><li><span>Advanced degree in Life Sciences, Engineering, or Pharmacy.</span></li><li><span>10+ years in biopharma operations, manufacturing, MSAT, or compliance, ideally in GMP site launches or transformations.</span></li><li><span>Strong knowledge of EU GMP, ICH, Annex 1/15, inspection readiness requirements.</span></li><li><span>Proven experience with validation, qualification, and GMP readiness deliverables.</span></li><li><span>Familiarity with digital GxP systems (MES, PI, DeltaV, LIMS, eQMS).</span></li><li><span>Demonstrated leadership in lean deployment and continuous improvement programs.</span></li><li><span>Lean Six Sigma Green Belt or Black Belt certification appreciated.</span></li><li><span>Fluent in English and French.</span></li></ul><p><span><b>Success Profile</b></span></p><ul><li><span>Pragmatic and hands-on leader who thrives in GMP launch environments and can guide the transition to maturity.</span></li><li><span>Trusted partner to QA, ensuring collaboration while securing Ops ownership of compliance.</span></li><li><span>Recognized change agent, compliance-driven and efficiency-oriented.</span></li><li><span>Strong operational leader, capable of reinforcing accountability and building a high-performing Operations organization.</span></li></ul><p></p><p></p><p><span>FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.</span></p><p><span>ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.</span></p><p></p><p></p>