Full-Time
Commissioning & Qualification Leader
Posted on 9/25/2025
Sanofi
10,001+ employees
Global pharma company; vaccines and R&D
No salary listed
Marcy-l'Étoile, France
In Person
 Engineering Management (1) |
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- Bachelor of Applied Science and Engineering
- Professional Engineer
- 10 years of experience in Commissioning and Qualification and/or Engineering projects in pharmaceutical industry, preferably injectables and/or biologics products
- Fluent in French and English spoken and written compulsory
- Deep knowledge in pharmaceutical and industry regulations and standards associated with C&Q and Engineering
- Significant experiences as C&Q Lead of various sizes of investment projects, including large projects
- Competencies for managing a team and managing transversal interfaces, and taking the lead
- Good relationships and communication skills to collaborate effectively with peers, stakeholders, partners across the organization, thus impacting positively business results
- Ability to influence and build relationships across the organization
- Customer centricity/results oriented/teamwork/clear thinker/lean oriented
- Execute the project's C&Q strategy on the Neuville sur Saône site, until the closure of all C&Q activities and deliverables under the Global Engineering scope (non-product dependent PQ and Turn-Over Packages).
- Develop and lead the project C&Q team, ensuring appropriate C&Q training, expertise and delivery.
- Ensure periodic reporting on C&Q progress.
- Define new project C&Q strategy to accommodate new processes within the Modulus building in accordance with external and internal regulatory and industrial requirements applicable to the Neuville site.
- Update the project C&Q plan and system-specific validation plans. Contribute to the development of the project validation master plan
- Contribute to the development of the C&Q schedule, performance indicators, monitoring tools, resource plan and specific training activities
- Develop the strategy to maintain Modulus building systems qualified: Establish a program for the periodic requalification of systems
- Define the requalification strategy following changes in the specific EVF context
- Develop the specific KNEAT templates and procedures, as necessary
- Interact with the legacy part of Neuville's site to: Ensure that the systems are properly overtaken by the site's support departments (Maintenance, Metrology, etc.)
- Facilitate the transfer of knowledge and responsibility to the final user at the end of the project
- Ensure that standards (e.g. Engineering, EHS, Quality) in relation to CQV activities are implemented & validated before execution with a focus on design to cost solutions
- Ensure that digital core model tools (e.g. KNEAT) are implemented for the projects
- Collaborate closely with Modulus Project Manager to identify the appropriate staffing for the project organization to ensure all CQV key competencies are available
- Ensure optimized C&Q solutions for equipment, systems and facilities
- Ensure anticipation of project risks, tracking of action plans & communication on & across the site to manage risk all along the project
- Ensure Sanofi signature for protocols, reports
Sanofi is a global pharmaceutical and biotechnology company that develops, manufactures, and sells prescription medicines, over-the-counter products, and vaccines. Its products span immunology, oncology, rare diseases, and vaccines, addressing unmet medical needs through a strong focus on research and development. Sanofi's core product model relies on large-scale R&D, strategic partnerships, and licensing to bring new therapies to markets, with revenue generated from product sales and collaborations. The company differentiates itself by leveraging its global reach, diverse portfolio, and emphasis on patient-centric solutions, safety, and quality to navigate regulatory environments in developed and emerging markets. The company’s goal is to improve health outcomes and quality of life for people worldwide by delivering innovative treatments and vaccines that meet unmet medical needs.
Company Size
10,001+
Company Stage
IPO
Headquarters
Paris, France
Founded
1973
Simplify's Take
What believers are saying
- Pharma launches sales surged 49.6% to €1.2B in Q1 2026 from Ayvakit and ALTUVIIIO.
- Dupixent generated €4.2B in Q1 2026 across nine indications, driving 13.6% sales growth.
- Analysts project 16.4% undervaluation with fair value €95.53 versus €79.82 share price.
What critics are saying
- Dupixent patents expire 2031, enabling Mylan and Teva generics to erode €4.2B quarterly sales.
- Regeneron reimbursements drop €400M in 2026, slashing amlitelimab phase 3 funding.
- GSK Arexvy captures 60% RSV market share, halving Beyfortus €284M Q1 sales by 2027.
What makes Sanofi unique
- Venglustat crosses blood-brain barrier as oral GCSi for GD3 neurological symptoms.
- LEAP2MONO phase 3 trial superior to ERT on neurological endpoints at week 52.
- FDA Breakthrough Therapy designation for venglustat in GD3 on March 18, 2026.
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Benefits
Health Insurance
Professional Development Budget
Parental Leave
Company News
Novo Holdings joins $165 million crossover financing for Windward Bio to advance pipeline of long-acting immunology therapies with best-in-disease potential. * Led by OrbiMed, with participation from RA Capital Management, Janus Henderson Investors, Sanofi Ventures, and existing investors, including Novo Holdings * Proceeds will advance lead candidate WIN378 into Phase 3 and WIN027 into respiratory and dermatology studies by Q4 2026 * WIN378 has the potential to be the first-to-market ultra long-acting anti-TSLP antibody for asthma and COPD * WIN027 is a long-acting bispecific targeting TSLP and IL-13 with best-in-disease efficacy potential Windward Bio, a private, clinical-stage biotechnology company committed to improving outcomes for people living with serious immunological diseases, today announced an upsized $165 million crossover financing led by OrbiMed, with participation from existing Series A investors including Novo Holdings, Blue Owl Healthcare Opportunities, SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners. The financing also included new investors RA Capital Management, Janus Henderson Investors, and Sanofi Ventures. Proceeds will significantly extend the company's cash runway and enable multiple clinical readouts in the next 12 months. Since launching in January 2025, Windward Bio has in-licensed 2 clinical-stage assets, raised $365 million, and rapidly advanced both programmes[RW1] in the clinic. WIN378, the lead programme, is a next-generation, fully human monoclonal antibody that potently binds to the thymic stromal lymphopoietin (TSLP) ligand. This well-validated cytokine plays a key role in the development and progression of a wide array of immunological diseases. WIN378 has the potential to be the first-to-market, ultra long-acting anti-TSLP antibody with twice-yearly dosing. The financing will accelerate the development of WIN378, which is currently being studied in the Phase 2/3 POLARIS programme in asthma. The Phase 2 dose-ranging component of POLARIS is fully recruited, with initial data expected in the second half of 2026. The first Phase 3 study of WIN378 is expected to begin in the fourth quarter of 2026. The Phase 2 SIRIUS study in chronic obstructive pulmonary disease (COPD) is anticipated to start in the second quarter of 2026. WIN027, the second programme, is a highly potent, long-acting bispecific antibody targeting both TSLP and interleukin-13 (IL-13) - two well-validated and synergistic drivers of inflammation in severe asthma, COPD, and atopic dermatitis. WIN027 is currently in a Phase 1 study with data readout expected by the end of 2026. The financing will support multiple proof-of-concept studies across respiratory and dermatology indications starting in in the fourth quarter of 2026. "We are excited to expand our shareholder base of top-tier investors to include RA Capital, Janus Henderson, and Sanofi Ventures" said Luca Santarelli, MD, Founder, Chief Executive Officer, and Board Chair of Windward Bio. "This financing further strengthens our balance sheet and allows us to further advance our programmes of next-generation therapies for patients living with serious respiratory and dermatological diseases." Naveed Siddiqi, Senior Partner, Venture Investments, Novo Holdings, said: "Spearheaded by a highly experienced clinical and commercial leadership consisting of serial entrepreneurs, Windward Bio has made rapid progress since it launched in 2025, including bringing in a second clinical stage asset, WIN027. There is much more to be done towards improving dosing frequency and outcomes for the benefit of patients suffering from serious and chronic immunological conditions, and as a significant shareholder, we are pleased to support Windward Bio as it advances its innovative and developing pipeline into late-stage trials." About WIN378 WIN378 is a next-generation, fully human monoclonal antibody that potently inhibits the TSLP ligand. This clinically validated target plays a key role in the development and progression of a wide array of immunological diseases, including asthma and COPD. WIN378 has been engineered to achieve half-life extension (HLE) and to have a silenced effector function. It has been studied in a Phase 1 trial, which confirmed an extended half-life suitable for twice-yearly dosing, demonstrated a low rate of antidrug antibodies, and was safe and well tolerated up to the highest dose tested. WIN378 is administered subcutaneously. Windward Bio licensed the global rights (excluding Greater China and several Southeast and West Asian countries) for WIN378 from Kelun Biotech (also known as SKB378) and Harbour BioMed (also known as HBM9378). WIN378 is currently being evaluated in the POLARIS Phase 2/3 asthma study with initial readouts expected in the second half of 2026. A Phase 2 study in COPD is anticipated to begin in the second quarter of 2026. About WIN027 WIN027 is a potential best-in-class, humanised bispecific monoclonal antibody with subpicomolar affinity for TSLP and IL-13, well-validated targets in immunological conditions. It has been engineered to achieve an extended half-life and enable less frequent dosing. Through this dual, long-acting inhibition, WIN027 is designed to set a new standard of efficacy in conditions such as asthma, COPD, and atopic dermatitis, potentially delivering deeper and more durable disease control than existing biologics. WIN027 is currently in Phase 1. Windward Bio licensed the global rights (excluding Greater China) for WIN027 from Qyuns Therapeutics (also known as QX027N). About Windward Bio Windward Bio is a clinical-stage biotechnology company with deep discovery, development, and commercialization expertise committed to transforming the treatment of people living with serious immunological conditions. Its lead programme is WIN378, a potential best-in-disease, ultra long-acting anti-TSLP monoclonal antibody currently in a Phase 2/3 trial for asthma. The pipeline also includes WIN027, a clinical-stage, long-acting anti-TSLPxIL-13 bispecific with broad therapeutic potential across immunological diseases, which is currently in Phase 1. The company is building a discovery pipeline of long-acting bispecific antibodies, targeting validated biology in respiratory and dermatological conditions. Media Enquiries Marie-Louise Jersin, Senior Communications Lead, [email protected]
Regeneron Pharmaceuticals and Sanofi announced that the European Commission has approved Dupixent (dupilumab) for treating moderate-to-severe chronic spontaneous urticaria in children aged 2 to 11 years. The approval applies to patients with inadequate response to histamine-1 antihistamines who are naïve to anti-immunoglobulin E therapy. This expands Dupixent's existing EU approval for CSU, which previously covered adults and adolescents aged 12 and older. The drug is now approved for children under 12 across four chronic diseases driven partly by type 2 inflammation. The approval is based on data from the LIBERTY-CUPID clinical trial programme, including efficacy data extrapolated from two Phase 3 adult trials and pharmacokinetic, safety and efficacy data from the CUPIDKids Phase 3 trial in children aged 2 to 11.
The European Commission has approved Dupixent (dupilumab) for treating moderate-to-severe chronic spontaneous urticaria in children aged two to 11 years with inadequate response to antihistamines. Developed by Sanofi and Regeneron, this marks the first targeted medicine for young children with the condition in the EU. The approval, based on the LIBERTY-CUPID clinical study programme, expands Dupixent's CSU indication to children as young as two years. The drug is now approved for children under 12 across four chronic diseases driven partly by type 2 inflammation. Clinical studies showed Dupixent significantly reduced urticaria activity, including itch and hives, compared with placebo at Week 24. Safety results were consistent with Dupixent's known profile in dermatological indications. A supplemental biologics licence application is under review in the US for the same patient population.
The European Commission has granted conditional marketing authorisation for Sanofi's Rezurock (belumosudil) to treat chronic graft-versus-host disease in adults and children aged 12 years and older weighing at least 40 kg. The treatment is approved for patients when other options provide limited benefit or have been exhausted. The approval follows a positive opinion from the European Medicines Agency and is based on the ROCKstar phase 2 study, which demonstrated a 74% overall response rate. Nearly half of chronic GVHD patients require third-line treatment, yet therapeutic options have remained limited in the EU. Rezurock is already approved in 20 countries, including the US, UK and Canada. More than 20,000 patients have been treated with the medicine since its first US approval in July 2021.
Bernstein analyst Justin Smith has initiated coverage of Sanofi with an "Outperform" rating and a price target of €110, representing 37% upside from current levels. The analyst believes the French biopharmaceutical company's new chief executive will unlock shareholder value. Sanofi appointed Belén Garijo, former CEO of Germany's Merck KGaA, as its new chief executive in February. The 65-year-old Spanish executive will take charge in late April, replacing Paul Hudson after his six-year tenure. The company says Garijo will strengthen productivity, governance and innovation capacity in research and development. Sanofi shares have declined over 4.5% since the beginning of 2025. The stock trades at a forward price-to-earnings ratio of 9.26.