Sanofi Group Director Quality in Framingham, Massachusetts

The Quality organization supports the Seprafilm (medical device), Analyte Specific Reagents (ASR) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations at the Genzyme 74/76 NYA Manufacturing Facility. The Quality organization comprises Quality Assurance Operations, Quality Compliance, Quality Engineering (QE), Validation, Quality Management Systems, and Quality Control. The organization supports the approximately 120 employees at the site including the Manufacturing, Manufacturing Technical Support and Material Management organizations.

Position Summary

This position will oversee and develop Quality Engineering (Including Design Control, Change Control, Electronic System Management and Supplier Management) and Validation, and with a supporting role to colleagues overseeing the other aspects of the Quality organization indicated below, to include:

Quality Assurance Operations

Quality Compliance

Quality Management Systems (Quality Champion, Risk Champion, Global Response Team, Corporate Standard remediation coordination)

Core Responsibilities

Manage resources (e.g. budgets, forecasts, equipment,, personnel).

Interpret and execute procedures that typically affect subordinate organizational units or subunits.

Perform work and make decisions that require the comparison and evaluation of possible courses of conduct and the consistent exercise of independent judgment and discretion.

Define necessary resources to meet production schedules that may run across multiple shifts while maintaining company standards.

Ensure completion of projects on schedule and within budget.

Assist with future plans including site improvements and expansions.

Select, develop and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.

Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.

Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.

Develop work plans, assign tasks, and supervised team (s).

Ensure that staff has appropriate knowledge of department processes and procedures.

Provide input into the department budget.

Maintain and report applicable department or organizational metrics.

Accountable for project completions and achievement of compliance goals.

Represent department in Project Team meetings.

Interact with Project teams and cross-functional groups as they impact the operation.

Address and/or escalate site compliance problems and issues.

Additional Responsibilities

Plan and coordinate operations to meet production schedules, product standards, and operational costs.

Prepare production, personnel and financial reports to achieve production goals.

Production scheduling, meet demands of internal customers, and work with a cross functional team to meet product release cycle time.

Participate in the short and long range planning and budgeting process.

Ensure timely resolution of deviations related to production batches, and the on time implementation of corrective and preventative actions (CAPA).

Manage for Daily Improvement-Engage the staff in continuous improvement efforts.

Manage change control process to implement new equipment and process improvements.

Manage product risk profiles as they are impacted through change control.

Participate in the CAPA program for the site, including review and approval of CAPA plans and implementations.

Compile and report on internal compliance metrics during Management Review and other forums.

The ideal Candidate:

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:

Respecting the laws and operating within the applicable 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 this 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.

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

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.

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.

Required Qualifications

Bachelor’s degree or equivalent.

10 years relevant manufacturing experience in Biologics, Medical Devices or Pharmaceuticals.

5 years in a supervisory/ management capacity in a cGMP/clean room environment.

Desired Qualifications/ experience

Computer System Validation Experience, Design Control experience, aseptic processing knowledge

Good working knowledge of ERP.

Working conditions

Must be able to gown and enter clean-room

Genzyme Corporation (a Sanofi company) 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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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.

Sanofi, Empowering Life

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.

Sanofi, Empowering Life