Sanofi Group Manager Commissioning and Qualification in Framingham, Massachusetts

The Manager of Commissioning and Qualification (C&Q) is responsible for the administration of the Commissioning and Qualification activities at the Framingham, MA manufacturing sites. This position will report to the Associate Director, Commissioning and Qualification and will be a key contributor to the Manufacturing Engineering team. The Manager C&Q will work closely with key stakeholders in a variety of departments within the manufacturing sites to assure all design changes, commissioning needs, and operational support requirements are met.

Position Overview/Key Responsibilities

The Manager C&Q will:

  • Act as primary C&Q interface with Project Management, Validation, and Quality.

  • Lead the use of the site C&Q Program and ensure alignment with Genzyme’s Corporate Standards along with engineering best practices.

  • Be responsible for the management, mentoring and development of C&Q staff.

  • Lead development, approval, execution, resolution and reporting of all project specific engineering C&Q documentation.

  • Responsible for project documentation management and quality of the Engineering Turnover Documentation.

  • Responsible for administration of training for site commissioning and qualification methods to execution team.

  • Responsible for managing commissioning and qualification phase advancement.

  • Monitor/evaluate contractor safety performance throughout the duration of the project.Provide oversight to project contractors to ensure Site C&Q Program methods are being utilized per procedures. Leadership Qualifications:

  • This individual should be a self-starter with strong interpersonal, organizational, and technical skills. Capability to work both independently and in a team environment. Strong analytical and communications skills are required.

  • Excellent written and verbal presentation skills to support interactions with engineering management are required.

  • Strong mentoring and development experience is requried.

  • Must be able to establish strong working relationships with stakeholders (Quality, Manufacturing, and MSIT) to ensure high quality deliverables meeting CGMP and site quality requirements.Basic Qualifications:

  • Bachelor’s Degree in Engineering or Science and 5+ years of Commissioning and Qualification experience.

  • Minimum of 3 years CQV Project Management, Functional Management or combination required Preferred Qualification:

  • Must be able to oversee facilitation of practices consistent with the site C&Q program during the execution of projects as well as application for legacy systems and equipment.

  • This individual should be a self-starter with strong interpersonal, organizational, and technical skills. Capability to work both independently and in a team environment. Strong analytical and communications skills are required.

  • Demonstrated knowledge of cGMPs and expertise in current commissioning and qualification methods utilizing industry guidance for applied risk management methods for the commissioning and qualification of manufacturing systems in a biopharmaceutical manufacturing environment.

  • Demonstrated C&Q expertise in process automation, building automation systems and distributed control systems, working knowledge of CGMPs, sanitization and passivation, and Biopharmaceutical Manufacturing.

  • Experience in a CGMP industry is required, Biotech preferred.

  • Experience with current commissioning and qualification methods, including ISPE, ICH, and ASTM E2500 methodology

  • Knowledge of FDA and EU regulatory requirements pertaining to bio-processing facilities

  • Minimum of 3 years’ functional management experience preferredKey Areas of Expertise:

  • GMP Process Equipment

  • Good Documentation Practice

  • Change control management

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.