Massachusetts Healthcare Jobs

Job Title: Manager, External Manufacturing, North America Quality

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. Your job, as Manager, External Manufacturing, North America Quality, will be to partner with our contracted manufacturing organization (CMO), providing oversight, communication and support to the team, as well as ensuring the quality and regulatory compliance of products in accordance with cGMPs and Sanofi Quality directives.

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:

• Ensures the efficiency of Quality System implemented between Sanofi and the sub­ contractors ensuring a relevant management for complaints, deviations, change controls, non-conformities or any activity aiming to ensure the production, the control and the release of products accordingly with Quality requirements.

• Strengthens the Quality and Regulatory strategy particularly during crisis management and verifies the implementation of the relevant action plans.

• Support the External Manufacturing North America Audit Program by working with and conducting contractor audits to assure compliance to Sanofi Quality Directives, current Good Manufacturing Practices (cGMPs), and regulatory filings. Leads or participates to the subcontractors audits and manages the CAPAs that follow.

• Support projects as assigned such as new product launch teams.

• Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks, to Sanofi products.

• Develops and negotiates the subcontractors Quality Agreements defining the responsibilities between both parties and provides quality advice to subcontractors.

• Participates with subcontractors to find solutions concerning quality issues.

• Respond to customer complaints, including close out and determination of corrective actions.

• Identify and prevent or resolve issues that could impact the continuity of supply of existing products.

• Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations.

• Regular and frequent contact with vendors through formal meeting (systematic business review meeting) or informally when issues can't wait.

• Constant contact with the Senior Director of Quality, regulatory, MSAT and global quality.

• Regular contact with Legal to ensure the compliance of the activity to all laws and in preparation of Quality Agreements.

• Collaborate with numerous country's affiliates quality personnel.

• Decision making for quality and compliance issues including but not limited to the disposition of product, deviations, change control, qualifications/validation, approval of investigations and assist in the decisions to inform regulatory agencies on issues

• Solve problems by working with quality and technical counterparts at external manufacturing sites as well as the technical/analytical team internally.

DECISION MAKING AUTHORITY.

Identify the types of decisions made by this job as well as those that must be referred to a superior (i.e., authority to implement plans, personnel decisions, changes to policy, etc.)

After proven competency levels, the individual is expected to make routine decisions on change control disposition, updates to filings, etc. Decisions that are not routine will be brought to the attention of management.

KEY INTERNAL and EXTERNAL RELATIONSHIPS.

Relationship building and good collaboration with external manufacturers is vital to success in the role.

About You

• Earned Bachelor's degree in a relevant field

• 3+ years (5 preferred) in Operations or Quality with the application of cGMPs in a regulated industry (pharmaceutical industry preferred).

• Excellent oral and written communication skills (particularly in relation to cGMP documentation).

• Project management skills/experience is extremely helpful

• Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience preferred

• Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship

• Excellent team work and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects.

• Ability to effectively communicate with all levels of associates within and outside of the organization is essential.

• Significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries especially those related to handling product complaints and the associated regulations is highly preferred

• Thorough knowledge of GMP's and regulatory requirements (including Sarbanes Oxley) would be helpful

• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, API’s, lyophilized and medical drug/device combinations preferred

• Ability to communicate in French is desired but not required

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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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.

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)