Job Title: Operations Compliance Specialist
Location: Northborough, MA
About the Job
Materials Operations is a regulatory compliant service operation that is responsible for the safe and secure, Receipt, Storage, Shipping and Transport of Sanofi materials and products. Materials Operations is also responsible for supply chain security compliance, hazardous materials, import/export, inventory management & control, warehouse operations and other value-added logistics.
Operations compliance engineers main functions are leading deviation investigations and managing CAPA implementation, partnering with direct APU staff for enhancing and improving the APU instruction set, overseeing and supporting APU training program, and identifying and managing continuous improvement initiatives.
Senior Operations Compliance Engineer uses expert knowledge of compliance and GXP processes to manage investigation and improvement initiatives within the 11 Forbes APU operations.
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.
Main Responsibilities
Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines.
Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
Utilizes GMP process knowledge and investigation skill sets to identify and resolve issues, improve process operations and affect positive change.
Conducts complex document revisions and /or document management including batch production records, operations procedures, and cross functional procedures.
Works with APU to develop and maintain training materials and curricula on process operations, theory and compliance.
Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, Materials Operations and Label and Pack.
Works independently with minimal supervision and direction.
Participates in determining objectives of assignment.
Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion.
Effectively utilizes Microsoft office applications.
Creates and presents trending and metrics reports.
Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget.
Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services.
Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results.
Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues.
*Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
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 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's a great place to work and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
About You
Education / Experience
High school diploma / GED with minimum 7 years experience (or) Bachelor’s degree and minimum 3 years experience working in a Bio-Pharma regulated cGMP environment.
Bachelor’s degree in Biology, Chemistry, Biochemistry or Chemical Engineering
Knowledge of GXP regulations and guidance.
Minimum of 2 years experience with deviation management systems
Excellent critical thinking and technical writing
Excellent written and oral English language skills.
Proficient with change control requests, CAPAs and deviation quality systems
Proficient in critical thinking and technical writing
Experience leading cross functional teams and facilitating team meetings.
Ability to influence in a cross-functional environment.
Experience authoring and reviewing standard operating procedures, on-the-job-trainings and other controlled documents.
Proficient in balancing the speed of delivering work with quality and shows commitment to make improvements in both aspects
Effectively tracks tasks related to deviations, CAPAs, or CCRs to ensure on-time adherence, and delivers results on time.
Ability to work independently with minimal supervision to problem solve efficiently adhering to on-time delivery.
Experience with project management.
Experience with Veeva Vault.
Experience in troubleshooting, investigation and root cause analysis in a GXP environment.
Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, Materials Operations or Label and Pack.
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.
#GD-SG
#LI-GZ
#vhd
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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
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:
$74,250.00 - $107,250.00All 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.