Sr Manager, QA Compliance

Thermo Fisher Scientific Cambridge, MA

About the Job

  • When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

This position reports into the Viral Vector Services' Cambridge office.

How will you make an impact?

  • Responsible for ensuring compliance with all applicable provisions of the Quality Management System, as well as the regulations.
  • Represents Thermofisher Scientific VVS during regulatory inspections assuring management that requested information is produced in a timely, accurate and complete manner.
  • Assures that inspection / audit responses are timely and appropriate to maintain good standing with regulatory agencies.
  • Coaches and educates cross functional staff in regulatory inspection readiness activities.
  • Responsible for maintaining site licenses, renewals and paper inspections including holding department owners accountable
  • Acts as the lead SME for significant quality compliance issues within the facility.
  • Manages compliance budget and resources to maximize efficiency and maintain quality/compliance at high levels.
  • Develops, directs, and maintains quality systems in support the facility status in a manner consistent with global quality systems requirements, corporate standards and current regulatory requirements, and others as needed. Quality systems include but are not limited to audits and inspections, documentation and records management.
  • Direct, develop, and maintain DI compliance activities in alignment with applicable regulatory requirements.
  • Has decision-making authority for any Quality issues; informs Site Quality Head of critical issues in a timely manner. Builds and maintains expertise in the QA Compliance teams, including development of staff.
  • Provide leadership and management for the quality function and sustain the quality philosophy and lean culture.
  • Establish, maintain and optimize an effective quality management system.
  • Coordinates necessary personnel for internal, customer and third party quality system audits.
  • Implements the performance measurements necessary to effectively evaluate organizational performance and trends in product quality, services, customer satisfaction and the cost of poor quality.
  • Uses the results of performance evaluation to target improvement efforts.
  • Perform other duties as assigned.

How will you get here?

Education, Experience & Knowledge

  • BS in Biological Science or related technical field.
  • At least 10-15 years of related experience in the Quality Unit.
  • Extensive exposure to cGMP environment.
  • Strong organizational and time management skills. Prioritization and problem-solving skills.
  • Strong knowledge of Quality procedures, processes and guidelines. Recognized by colleagues as a source of expertise.
  • Experience leading conversations with customers (internal and external).
  • Strong interpersonal and communications skills; written and oral.
  • Understanding of applicable regulatory requirements.

PHYSICAL DEMANDS/FACTORS:

While performing the duties of this job, the employee:

  • Demonstrate excellent organization and time management skills.
  • Needs Ability to aseptically gown and/or sterile gown as needed
  • Ability to function in a dynamic environment and balance multiple priorities simultaneously