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Head of Quality Assurance Validation

Thermo Fisher Scientific Inc.

This is a Full-time position in Cambridge, MA posted June 11, 2021.

Job DescriptionThermo 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 InformationCambridge, MAHow will you make an impact?Implements the overall quality strategy for the facility at the validation strategy. Partners with the Site Head of Quality and Senior Leadership Team to ensure alignment with Engineering and support functions in executing the strategy.What will you do?* Acts as the lead SME for significant quality validation or compliance issues within the facility.* Manages QA Validation (QAV) budget and resources to maximize efficiency and maintain quality/compliance at high levels.* Develops, directs, and maintains quality systems in support of facility validated 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.* Oversees all aspects of QA Validation operations within the facility, including but not limited to executed equipment and instrument validation, method validation, data integrity, computer systems validation, deviation investigations, change controls, customer quality support and SOP review.* Direct, develop, and maintain DI compliance activities in alignment with applicable regulatory requirements.* Provides Quality support to the life cycle of analytical equipment / instrumentation and analytical method validation / verification, including qualification and validation activities* Manage QAV/QE function responsible for facility, equipment, process and utility validation, ensuring equipment performs suitably for its intended use, property maintained and calibrated.* Ensures QAV support for internal and external project and team meetings.* 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 Validation 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* BS in Biological Science or related technical field – required.Experience (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 simultaneouslyThermo 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.