Quality Lead External Manufacturing Product Team

Job Title: Quality Lead External Manufacturing Product Team

Grade Level: L4-1

Hiring Manager: Anna Ryabkova

Location: Remote (Local to Indianapolis)

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.

The External Manufacturing and Supply (EM&S) Large Molecule Specialty Care organization is responsible for all Contract Manufacturing Organizations (CMOs) across the Specialty Care GBU that deliver Sanofi products. We serve the GBUs within M&S with drug substances, drug products, and finished goods, aiming to develop into a best-in-class organization that continuously strives towards three priorities: (i) Ensure Supply, (ii) Deliver Financially, and (iii) Grow Talent. In addition to running the business, we are committed to transforming the business by defining our strategic global footprint for preferred partners and deploying the right technology in centralized performance management of CMOs.

The External Manufacturing Product Team (EMPT) Quality Lead is a crucial role within Sanofi's Global External Manufacturing function. This position provides quality leadership and compliance oversight for multiple products manufactured by CMOs and Alliance Partners. This role is essential in maintaining Sanofi's quality standards across its external manufacturing network while driving continuous improvement and ensuring regulatory compliance.

Main Responsibilities:

• Serve as the primary Quality contact for assigned CMOs and External Supplies.

• Accountable for on-time and in-full release of products at CMOs/External Suppliers within the EMPT unit, and for tracking EST KPIs.

• Actively engage as a Quality representative in internal core team meetings and joint meetings with the CMO.

• Oversee the entire manufacturing process to ensure all steps are validated and adhere to Standard Operating Procedures (SOPs).

• Provide expert quality guidance to internal and external stakeholders for assigned products.

• Manage quality issues associated with ongoing operations, including deviations, change controls, and Quality Agreement lifecycle management.

• Drive continuous improvement initiatives within the department and across Sanofi to support external supply strategies.

• Support final product release at CMO sites, adhering to strict timelines.

• Ensure presence during all manufacturing operations at partner facilities.

• Collaborate effectively with cross-functional teams, including P2MF (Plan to Manufacture) and P2D (Plan to Deliver) streams.

• Drive continuous improvement in the performance of the supplier in areas of Safety, Quality, Cost & Delivery.

• Manage products/CMOs from a quality and operational perspective, ensuring activities align with contract guidelines (MSA & QTA) and providing routine technical support.

• Provide leadership, guidance, and direction to CMOs consistent with GxP and corporate governance.

• Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) and internal business partners (GSC, MSAT, Legal, etc.).

• Ensure execution of CMO Management processes, including routine governance meetings, documentation of decisions and actions, and participation of the correct attendees. Facilitate internal stakeholder alignment before joint governance meetings.

• Adhere to the Risk Management Program, proactively identifying, evaluating, documenting, and communicating risks potentially impacting quality, compliance, and supply. Participate in multi-disciplinary teams to define remediation plans to mitigate risks impacting products and GxP operations.

• Collaborate with Supply Chain to monitor CMO inventories, assess potential risks, and provide proactive remediation plans.

• Ensure compliance through active participation in all applicable quality governance forums. Accountable for on-time delivery of Quality System-related records.

• Act as Quality SME for CMO/External Suppliers within the EMPT unit, involving appropriate Technical SMEs to ensure process changes are vetted within Sanofi to determine acceptability and impact on Sanofi manufacturing and quality processes.

• Execute CMO projects in conjunction with the CMO organization and applicable EM&S business partners.

About You

Minimum Requirements:

• Bachelor’s degree in a scientific background or equivalent with 12+ years of experience in the pharmaceutical/biotech industry.   

• OR Master’s degree in a scientific background or equivalent with 10+ years of experience in the pharmaceutical/biotech industry.  

• Must have 10+ years of experience in a Quality function. 

• Must have 5+ years supervisory and/or management experience.

• Must be willing to travel 70% of the time to Indianapolis, for CMO oversight

Preferred Skills:

• Previous experience in radioligand therapy (RLT) highly preferred

• Familiarity with global cGMP and ISO regulations relating to medicinal products.

• Knowledge or experience working with Radio Ligand Therapies is preferable.

• Knowledge of Technical Transfers and Commercial readiness.

• Experience preparing a site for regulatory inspections.

• Basic or good understanding of data management and IA digital products.

• High level of autonomy: Executes, comfortable with ambiguity, and adapts with agility. Takes calculated risks and anticipates potential issues.

• Relationship & Influence: Able to manage ambiguity and partners without solid reporting lines.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.