Full-Time

EM&S External Site Team Head Vaccines

External Manufacturing and Supply, Vaccines

Posted on 9/6/2025

Deadline 9/30/25
Sanofi

Sanofi

10,001+ employees

Global pharma company; vaccines and R&D

Compensation Overview

$210k - $303.3k/yr

Morristown, NJ, USA

In Person

Category
Biology & Biotech (4)
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Required Skills
Risk Management
Requirements
  • Bachelor’s degree with scientific background or equivalent and 15+ years of experience
  • OR
  • Master’s degree with scientific background or equivalent and 10+ years of experience
  • Experience in operational roles, ideally as Site manager, SLT member
  • Good functional knowledge on industrial business processes
  • Good exposure to cross sites & cross GBUs networking is a plus.
Responsibilities
  • Ensures on time & in full delivery of products for CMOs and MAMPs within external site management unit; accountable for reporting of Vaccines & EM&S Key Performance Indicators. Drives continuous improvement in performance of internal and supplier Safety, Quality, Cost, Delivery & Involvement.
  • Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) & internal business partners (Global Supply Chain, Procurement, MSAT, Legal etc).
  • Serve as the first level of escalation from the External Manufacturing Product Teams as it relates to problems encountered with CMO activities, actively participates in CMO driven Joint Steering Committee (JSC) meetings. Escalates issues to appropriate forums, as needed.
  • Accountable to meet financial targets & ambitions (cost savings); develop and understand the functional P&L. Create and use digital tools to track progress to financial commitments.
  • Accountable to understand the contract guidelines and the impact to the product/departmental P&L.
  • Accountable to understand the products/ CMOs from an operational & financial perspective and responsible for routine technical support.
  • Accountable for the successful financial performance of the team according to budget, including Head Count, activity, Cost of Goods (COGS) and Operational Expenses. Accountable for negotiation on financial liability for failed or rejected lots to minimize or eliminate Sanofi liability.
  • Accountable for creation, review and approval of Strategic Plans governing the perimeter of the External Site Team.
  • Accountable for implementing Life Cycle management projects.
  • Ensures organizational compliance to CMO Management processes ensuring Core Team, Internal Steering Committee (ISC) and JSC meetings are routinely held, decisions and actions are documented, and the correct attendees participate.
  • Builds and facilitates collaborative business relationships across all functions internally, both within the Global Business Unit and other departments (Legal, Quality, Finance, Regulatory, Business Development etc). Is the primary point of contact for business unit; routinely attends appropriate governance forum meetings. Ensures inventory reconciliation processes are executed according to governing procedures.
  • Accountable for the adherence to the Risk Management Program to identify, evaluate, document, and communicate risks potentially impacting quality and compliance; involves a multi-disciplinary team to define remediation plans to mitigate risks impacting products and GxP operations.
  • Ensure Compliance through active participation at all applicable quality governance forums (including Quality Management Reviews and Periodic Business Reviews). Accountable for approval of critical deviations. Accountable for on time Quality System related records, also reviews and approve all Category 3 Change Requests.
  • All aspects of people management for EST direct reports and accountable for financial resource planning within budget, including generation and maintenance of labor model, and training compliance. Support Sanofi's DE&I initiatives. Develops and maintains a positive culture to create the right environment for highly productive teams in a psychologically safe environment.
  • Accountable for ensuring the appropriate organizational design, resources, skill sets and processes to effectively deliver on all EST commitments. Alternatively ensure proper prioritization of activities to fit within the organizational design.
  • Accountable for ensuring that project and sourcing activities are appropriately resourced or prioritized to ensure successful execution in collaboration with the Strategic Portfolio and Project Management (SPPM) team.
  • Accountable for standardization of processes and procedures required to manage CMOs and related work within External Site Team.
  • Accountable for revision and standardization of contracts terms across all CMOs in collaboration with procurement and legal business partners.
Desired Qualifications
  • Basic or good understanding of data management and IA digital products
  • Knowledgeable in E2E product & industrial strategy, performance management, project management
  • Knowledgeable in vaccines/biotech industry technologies
  • Strong analytical skills.
  • Good command of KPI target setting & monitoring

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 Jobs

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

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Company News

Novo Holdings
May 4th, 2026
Novo Holdings joins $165 million crossover financing for Windward Bio to advance pipeline of long-acting immunology therapies with best-in-disease potential.

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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. 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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]

Yahoo Finance
Apr 13th, 2026
Dupixent approved in EU as first targeted medicine for chronic spontaneous urticaria in children aged 2-11

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 Associated Press
Apr 13th, 2026
EU approves Sanofi and Regeneron's Dupixent as first targeted medicine for young children with chronic urticaria

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 Associated Press
Mar 31st, 2026
Sanofi's Rezurock approved in EU for chronic graft-versus-host disease treatment

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Yahoo Finance
Mar 30th, 2026
Bernstein initiates Sanofi with 'outperform' rating, $123 target price

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.

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