Compliance & Continuous Improvement Director (Operations) - all genders
il y a 1 semaine
Job title : Compliance & Continuous Improvement Director (Operations)
Location : Toulouse
We're excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine Click to learn more.
Role Summary
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.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged
The future is ours to shape
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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