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**Job Title:** QC Raw Materials PCU Leader

**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.

The Quality Control Department is responsible for the testing of Raw Materials and Components for use at Massachusetts manufacturing sites. The Quality Control Department is also responsible for sampling and testing Packaging Components, Single Use technology and any other element that is required for manufacturing and/or packaging of Drug Substance/Drug Products. The department is responsible for the management and continuous improvement for control, testing, and inspection of raw materials.

Other responsibilities include life cycle management of methods and analytical instrumentation, environmental monitoring.

The department has expertise in Method Validation, Raw Material onboarding, Analytical techniques, with the ability to provide site support for investigations.

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?

**This is an onsite role Monday-Friday that may require early morning/late evenings when necessary. Weekends as per business needs. **

Main Responsibilities:

This position provides leadership and direction through management and professional staff.

+ Responsible for the Chemistry operational and technical services functions within the Quality Control Raw Material organization

+ Leads chemical raw material onboarding, testing, and lifecycle management

+ Responsible for method development, validation and optimization

+ Directly responsible for all out-of-specification/unexpected results, laboratory events, and quality events regarding chemical raw materials in compliance with federal regulations and Sanofi standards

+ In-depth knowledge of GEMBA problem solving tools including Ishikawa, Fishbone, 5 Why’s, root cause analysis, and risk assessments

+ Facilitates the implementation and maintenance of Quality methods, processes and operations for new or existing products and/or technologies.

+ Participates in department budget planning

Specific CGMP responsibilities include:

+ Maintaining a safe, efficient, functional and compliant laboratory developed to the required standards in accordance with site and corporate guidelines

+ Developing strategies to continuously improve data management practices and test method reliability and repeatability

+ Ensure inspection readiness and actively participate and lead audits as it pertains to impacted areas

+ Actively influencing the development and formalization of corporate laboratory control standards, policies and guidelines

+ Contribute to framework for department objectives, operation schedule, processes and budgets

+ Providing effective leadership including developing and implementing objectives and goals, performance reviews, training and development, and supporting workforce diversity in alignment with site priorities

+ Ensuring compliance with all legal and business requirements and Sanofi policies and practices.

+ Provides Raw Material expertise to the Sanofi network. Ability to work cross functionally both internally to Northborough as well as with other Sanofi sites

About You

Leadership Qualifications

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

+ Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures

+ Being honest and treating people with respect and courtesy.

+ Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.

+ Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgement in performing our jobs.

+ **Leading People** Sanofi’s leaders motivate, inspire, build and retain highly effective manufacturing teams while managing for high performance and developing others. They are learners and courageous decision makers.

+ **Leading the Business** Sanofi’s leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

+ **Delivering to Customers** Sanofi’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

Basic Qualifications:

+ Bachelor's Degree in a science or technical field and10 years of experience in pharmaceuticals or a related industry – required.

+ 6+ years in a management/supervisory position – required.

+ An equivalent combination of education and experience - may be considered.

Preferred Qualifications:

+ Experience reading and interpreting complex documentation for compliance with procedures, standards, assay validation and qualification

+ Experience demonstrating initiative and attention to detail

+ Demonstrated strong understanding of the pharmacopoeias (US, EU, JP, and ChP).

+ Proven reliable communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management.

+ Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives.

+ Proven ability to work cross-functionally within the greater Sanofi network

Special Working Conditions:

+ Ability to gown and gain entry to manufacturing areas.

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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\#LI-GZ

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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 (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:

$125,250.00 - $208,750.00

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)