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Director of Operations, GMP Packaging & Labelling

  • SANOFI
  • Northborough, MA, United States
  • May 11, 2019

Job Description

Packaging Operations, located at the Northborough Operations Center, is responsible for labeling and packaging of final drug product vials as finished product for sale and distribution to U.S., European and International markets in support of a global patient population.

In the process of performing these functions, the Director leads the Packaging area and interacts with and receives support from the Quality Assurance, Materials Management, Facilities Engineering, Validation, Metrology and Manufacturing Technical Support groups. In addition, Packaging interacts with outside contractors, vendors, internal auditors and representatives of various Regulatory agencies.

Basic Qualifications????????

  • Bachelors Degree
  • 15+ years experience supervising multiple levels and disciplines of direct reports in a GMP environment.
  • Extended experience in packaging in a GMP environment.
  • Experienced leading packaging teams and support staff to maintain adherence to a demanding production schedule.
  • Training, coaching, and leadership experience.
  • Experience in making tactical decisions on safety, process, scheduling and personnel-related issues.
  • Ability to effectively and appropriately escalate operational issues.
  • Experienced in establishment of safe practices in a GMP environment.

Preferred Qualifications

  • Master?s degree and 10 years GMP experience.
  • Experienced managing departmental budget
  • Proficient with validated Deviation Management Systems (i.e. Trackwise, Phenix).
  • Familiarity with MES and or automated systems

Minimum? 5 years of people management experience

  • Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner.
  • Identifying opportunities to improve packaging processes and practices.

Demonstrated knowledge of compliance and regulatory requirements

  • Experienced in troubleshooting, investigation, root cause and risk analysis in a GMP environment.
  • Experienced working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering and Validation

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.