Head of Commissioning, Qualification, and Validation (CQV)

Job Title: Head of Commissioning, Qualification, and Validation (CQV)

Location: Framingham, MA Morristown, NJ Swiftwater, PA

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. 

Within M&S and Global Engineering (GE) Technologies and Standards team, the Head of Commissioning, Qualification & Validation (CQV) is responsible for developing, maintaining and implementing a harmonized and digitized methodology for the planning and execution of Commissioning, Qualification & Validation (CQV) activities under Global Engineering perimeter.

The Head of CQV leads the simplification, standardization and digitization of CQV activities managed by global and local Engineering, across all of Sanofi M&S. He/She is in charge of defining and deploying best-in-class practices, optimizing the delivery model and developing and implementing digital CQV solutions, use of GenAI and externalization approaches, for ensuring performance improvements during the CQV and startup phases of investment projects, with a focus on Tier 1 and Tier 2 projects.

This will include ensuring that the CQV resources, both internal and external, are effectivity and efficiently used so that Capital projects either meet or exceed budget targets, with an expectation of achieving a reduction in cycle times for CQV and a cost reduction for the CQV phase of Tier 1 and Tier 2 projects.

The position is responsible for supporting CQV programs related to both projects as well as ongoing maintenance of validation (including periodic assessments and requalification/revalidation). The incumbent will interface with other CQV stakeholders including project engineering, MSAT, and quality assurance.

Main Responsibilities:

• In conjunction with CQV stakeholders, ensuring that Global Engineering Standards related to CQV are complied with and used by our manufacturing sites.

• Developing and leading a standardized, efficient, and effective approach to CQV within Sanofi, in close collaboration with Global M&S and Digital Quality (Q&V).

• Creating and leading the Global Engineering community of practice (CoP) for CQV and driving the performance expectations regarding cost and schedule.

• Ensuring the Business Process Owner (BPO) role for KNEAT core solution and driving greater adoption of CQV digitization through KNEAT.

• Ensuring that the engineering communities within our GBUs sites are suitably informed and trained so that they work with a standardized way regarding CQV

• Working with procurement to develop regional outsourcing strategies and obtain optimal pricing for CQV services

Key Relationships:

• Global Business Unit (GBU) and Regional Engineering Heads

• Regions Project Delivery Heads and site Engineering Heads

• Site CQV leads and the CQV Community of Practice

• Project Managers and Design Managers, Engineering SMEs communities

• Regions and sites C&Q Managers and Leads / C&Q SMEs

• Global HSE

• Global and sites Quality Q/V

• Digital Quality Q/V

• Global Procurement

About You

Basic Qualifications:

• BA/BS or equivalent degree preferably in Engineering, Operations, a Scientific discipline or other relevant discipline but will consider all degrees.

• 8+ years in Engineering, Quality or Operations, ideally having spent time at site and in a function with responsibility for Commissioning, Qualification, and Validation/CQV.

• In-depth mastery of Commissioning, Qualification, and Validation/CQV concepts and regulatory framework, as demonstrated through work experience or continuing education.

• Direct experience with deployment of digital validation platforms (such as Kneat or similar, digital tools).

• Front or back-room experience (both preferred) defending Commissioning, Qualification, and Validation/CQV documents, procedures, and programs before regulatory authorities.

• Demonstrated experience working in a global support organization and/or multi-site structure.

• Application of standardization (templates, forms, etc.) and continuous improvement to Commissioning, Qualification, and Validation/CQV processes.

• Experience assisting sites with pre-approval inspections (PAIs).

Preferred Qualif