Framingham, MA, 01701, USA
3 days ago
Head of External Manufacturing and Supply, North America
**Job Title:** Head of External Manufacturing and Supply, North America **Location:** Framingham, 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. To lead and develop EM North American DP team to ensure achievement of business goals and targets with high level of customer service & quality and in full compliance with Sanofi standards and processes and operating within guidelines from the FDA in managing external manufacturing. Support General Medicines GBU to rollout the IA EM&S strategies across all markets serviced from North America. 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:** **Ensure products delivery from CMOs at Sanofi standards** + Guarantee a high level of performance from all CMOs in the perimeter in terms of Quality, Customer Service and Costs. + Be responsible of products supply continuity, anticipate potential issues (back-up, inventory, …) and develop & deliver action plan in case of unexpected rupture. + Ensure high level of HSE and Quality at CMOs level in line with Sanofi standards and be accountable of CAPAs implementation after audits. + Select appropriate CMOs as per Sanofi guidelines and requirements and in a spirit of CMOs network rationalization and simplification. Act as the KAM across the CMO network for small molecules in North America. + Drive continuous improvement at CMOs level (including through SMS deployment) to target best-in-class performance and adapt to new GMP or Sanofi requirements. This position is open to international employees. Company-paid relocation benefits may be offered for this position. **Drive EM&S strategy implementation & lead key strategic projects** + Be the point of contact of North America commercial operations heads to ensure full alignment on vision and fulfilment of their business needs. + Accountable for creation, review, and approval of Strategic Plans for North American region in alignment with EM&S approach. + Drive all M&A and BD projects for EM&S for North American region, when required participate to due diligence and site visits & provide recommendations for Go/No Go decisions. + More specifically, co-lead Visco divestment in 2025, develop strategy to manage the site as a CMO supporting four products and ~$80m spend. + Lead the integration of products from BluePrint (if acquisition confirmed) from M&S standpoint, secure the team, retain talents, put in place new flows and review contracts with CMOs in order to secure full business continuity. **Ensure launch on time of key innovative products** + Be accountable for on time market launches of Rezurock in all geographies. + Ensure full delivery on all markets without any rupture on a WW basis. + Prepare Rilzabrutinib launch and guaranty launch readiness on time. **Secure financial performance** + Accountable of EM&S North American P&L and to meet financial targets & ambitions (cost savings, headcounts, transfer costs…) + Create and use digital tools to track progress to financial commitments. + Accountable for negotiation on financial liability for failed or rejected lots to minimize or eliminate Sanofi liability. + Accountable for ensuring that project and sourcing activities are appropriately resourced or prioritized. **Accountable of full compliance with Sanofi standards & processes** + 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 + 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. **Own contractual & business relationship with CMOs** + 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 (acting as KAM) + Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) & internal business partners (Global Supply Chain, Procurement, MSAT, Legal etc). + Accountable for implementing Life Cycle management projects + Accountable for standardization of processes and procedures required to manage CMOs and related work within External Site Team. **Represent Sanofi & EM&S with external partners** + 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 + Interface with external regulatory authorities as required + Participate actively to negotiations with procurement team **Ensure People development & PTW behaviors** + Accountable for ensuring the appropriate organizational design, resources, skill sets and processes to effectively deliver on all EM&S North American commitments. Alternatively ensure proper prioritization of activities to fit within the organizational design + Constant dialogues with teams so as to engage motivate and lead them for more empowerment & responsibilities. + Develop culture of strategic planning, individual development plan & succession plan to ensure full fit with future business needs and develop people accordingly **Scope** + ~10 CMOs, 20M€ spends, 2Mboxes and 80 SKUs. (does not include Visco or GB) **About You:** + A minimum of a Bachelor’s degree with scientific, engineering or business background or equivalent is required; a master’s degree with scientific background or equivalent is preferred. + A minimum 10 years of manufacturing and supply chain experience within the Pharmaceutical Industry & allied industry, is required + Selected candidate will have current or prior experience in leading and/or managing contracts + Current and/or prior experience in leading and developing a team is required + Languages: Fluent English + This position may require up to 20% overall business travel Technical skills: + Knowledgeable in E2E product & industrial strategy, performance management, project management required + Knowledgeable in pharmaceutical industry technologies required + Strong analytical skills are required + Good command of KPI target setting & monitoring required + Basic or good understanding of data management and IA digital products preferred Leadership skills o 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. o Results orientation: Demonstrated ability to drive initiatives from concept to execution. o High level of autonomy. Executes, comfortable with ambiguity, and adapts with agility. Takes calculated risks and anticipates potential issues. o 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. o 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. o Stretched ambition and act. Encourages the teams to stretch and do things differently & creates space for the teams to act. o Commit to Patients and full product quality. Makes sure the teams understand how to act for patients and customers. o Approaches the role with humility and thinks Sanofi first. 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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! **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.​ \#GD-SG ​ \#LI-GZ \#LI-Onsite \#vhd **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _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. _North America Applicants Only_ The salary range for this position is: $210,000.00 - $303,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) 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 (https://youtu.be/96EwNjb1TLo) 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 (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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