Thermo Fisher Scientific Head of Quality Compliance in Cambridge, Massachusetts
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
Location/Division Specific Information
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.
What will you do?
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?
- BS in Biological Science or related technical field - required.
10+ years of related experience in the Quality Unit.
Extensive exposure to cGMP environment.
Knowledge, Skills, Abilities
Strong organizational and time management skills. Prioritization and problem-solving skills.
Strong knowledge of Quality procedures, processes and guidelines. Recognized by colleagues as a SME.
Experience leading conversations with customers (internal and external).
Strong interpersonal and communications skills; written and oral.
Understanding of applicable regulatory requirements.
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
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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