Operations Compliance Engineer

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 or related.

• Knowledge of GXP regulations and guidance.<