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 Qualifications:

• Understanding of ASTM-E2500 methodologies, including efficiency opportunities through leverage of engineering documentation.

• Command of change management issues and methodologies at senior leadership level would be a strong plus.

• Strong experience in large investment projects development and execution; ability to lead and drive standardization across a global organization.

• Experience with early applications of AI to Commissioning, Qualification, and Validation/CQV protocol/report generation and review would be a plus.

• Experience of coaching, developing and influencing people at different levels of the organization; ability to facilitate complex workshops, trainings.

• Proven capabilities in program management.

• Proficiency in French would be beneficial but not mandatory.

Skills:

• Indirect influence through passionate leadership and mutual respect

• Ability to collaborate cross-functionally in a matrix organization

• Engage and manage stakeholders regardless of hierarchical position

• Develop, articulate, and deploy strategic initiatives across a global network

• Ability to interpret and communicate safety findings to senior functional leaders and top manufacturing leadership

• Ability to create business cases, recommend actions, and champion solutions based on sound data analytics

• Setting priorities through data analysis and trend identification

• Facilitating investigations and root cause analysis

• Development of effective corrective/preventive actions (CAPAs) with a focus on prevention and incident reduction

• Ability to organize and administer communities of practice (CoPs) as a vehicle for disseminating best practices, sharing lessons learned, implementing global initiatives, and collecting site feedback

• Ability to develop and deliver training on CQV topics

• Facilitation of risk assessment and mitigation methodologies (such as FMEA)

• Continuous improvement mindset and familiarity with lean methods to improve ways of working and simplify/standardize processes

• Ability to work transversally and build effective relationships in an international, multicultural organization

• Flexibility and adaptability to support a worldwide manufacturing network across multiple time zones, languages, cultures, and regulatory frameworks

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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