Location: Bridgewater,NJ, USA
**Job Title:** EMPT Lead
**Location:** Northborough, MA
**About the Job**
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
**Reporting to the Head of Specialty Care Large Molecules External Site Team** is accountable to lead and manage the relationship with the End-to-End External Partners & Suppliers within the EPMT perimeter, as the primary point of contact to ensure the on-time & in full manufacturing and distribution of products supplied by EM&S
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main Responsibilities:**
+ Accountable for on time and in full delivery of products for CMOs/External Suppliers within EMPT unit, accountable for tracking of EST KPIs. Drives continuous improvement in the performance of the supplier in areas of Safety, Quality, Cost & Delivery
+ Develops and maintains a positive culture to create the right environment for highly productive teams in a psychologically safe environment.
+ Accountable for management of the products/ CMOs from an operational & financial perspective, management of related activities against contract guidelines (MSA & QTA) and responsible for routine technical support.
+ Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) & internal business partners (GSC, MSAT, Legal etc)
+ Serve as the first level negotiation on financial liability for failed or rejected lots in collaboration with procurement.
+ Plan & implement life cycle management projects, including resource and financial planning, in collaboration with business partners.
+ Accountable for execution of CMO Management processes ensuring standard governance meetings are routinely held, decisions and actions are documented, and the correct attendees participate. Facilitate internal stakeholder alignment prior to joint governance meetings.
+ Key member of the Industrial Product Teams and Technical Product Team representing the EMPT.
+ Accountable for adherence to the Risk Management Program and proactively identifies, evaluates, documents, and communicates risks potentially impacting quality, compliance, and supply. Participates in multi-disciplinary teams to define remediation plans to mitigate risks impacting products and GxP operations.
+ In collaboration with Supply Chain ensures routine monitoring of CMO inventories, assessing potential risks and providing proactive remediation plans.
+ Ensure Compliance through active participation at all applicable quality governance forums. Accountable for on time delivery of Quality System related records
+ Accountable as Operational SME for CMO/External Suppliers within EMPT unit, and able to identify and involve the appropriate Technical SMEs to ensure process changes are vetted within Sanofi to determine acceptability and impact to Sanofi manufacturing and quality processes.
+ Accountable for execution of CMO projects in conjunction with CMO organization and applicable EM&S business partners.
**About You**
**Experience:**
+ Hands on experience in manufacturing operational roles, ideally as quality assurance manager for drug product manufacturing.
+ Working knowledge of Technical Transfers and Commercial readiness
+ Working knowledge of the design and implementation of a Quality Management System
+ Working knowledge of preparing a site for regulatory inspections
+ Working knowledge of complex distribution and supply chain network- e.g. Cell Therapy or just in time manufacturing and supply.
+ Good exposure to cross sites & cross GBUs networking.
+ Knowledge or experience working with Radio Ligand Therapies would be preferable.
**?** **Soft and technical skills:**
+ Basic or good understanding of data management and IA digital products
+ Knowledgeable in E2E product & industrial strategy, performance management, project management
+ Knowledgeable in biotech/pharmaceutical industry technologies
+ Strong analytical skills.
+ Good command of KPI target setting & monitoring
**Leadership skills:**
+ **Strategic thinking:** analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focus on priorities. Able to shape a vision. Able to lead & animate networks, teams, experts - Strong communication skills
+ **Results orientation:** Demonstrated ability to drive initiatives from concept to execution.
+ **High level of autonomy** : Executes, comfortable with ambiguity,??and adapts with agility. Takes calculated risks and anticipates potential issues.
+ **People development:** Engages and leverages everyone's strengths while being highly self-aware. Instore the culture of feedback & empower people to grow & manage his/her career path.
+ **Relationship & Influence:** able to manage ambiguity and partners without solid reporting line.
+ Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks.
+ Stretched ambition and take action. Encourages the teams to stretch and do things differently & creates space for the teams to take action.
+ Commit to Patients and full product quality. Makes sure the teams understand how to act for patients and customers.
+ Approaches the role with humility and thinks Sanofi first.
**Education:**
+ Bachelor's degree with scientific background or equivalent and 10+ years of experience
OR
+ Master's degree with scientific background or equivalent and 8+ years of experience
**Languages:**
+ Fluent English
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (