<p>Work Schedule</p> <p>Standard (Mon-Fri)</p> <p>Environmental Conditions</p> <p>Office</p> <p>Job Description</p> <p>Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 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 efficiency in their laboratories, we are here to support them. Our team of more than 100,000 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, Patheon and PPD. For more information, please visit www.thermofisher.com.</p> <p>Position Summary:</p> <p>Reporting directly to the Head of Quality Biologics and dotted line to the General Manager for the Plainville, MA Site. Leads the site's Quality organization and all Quality related programs and activities to support site operations for clinical and commercial manufacturing, testing, and release of biopharmaceutical products. Ensures business, quality and compliance goals are met and policies, standards, and relevant government issued quality and regulatory policies and guidelines.</p> <p>Responsibilities:</p> <ul> <li>To make sure each batch of medicinal product has been manufactured and checked in compliance with the local/ regional/ national/ international laws and in accordance with requirements of the Marketing Authorisation. Responsible for the approval or rejection of starting materials, intermediate, bulk, and finished products. Ensuring all vital testing is carried out and the associated records evaluated. </li><li>Effective strategy, monitoring and maintenance of the Quality System, and responsible for ensuring the qualification, maintenance of premises and equipment. ensuring appropriate validations are done. Accurate designation and monitoring of storage conditions for materials and products. Ensuring the inspection, investigation, and taking of samples, to monitor factors which may affect product quality. </li><li>Management of the Quality Unit of the site by assisting in the development of goals, providing leadership for health authority inspections as well as regulatory awareness programs for each agency. Establishes and maintains the standards for current Good Manufacturing Practices (cGMPs). </li><li>Supports the business development and commercial functions of the business in the assessment of new opportunities. </li></ul> <p>Qualifications:</p> <ul> <li> <p>B.S. in a scientific/technical field with proven ability within the biological and/or pharmaceutical industry. 5-10 years experience leading teams.</p> </li><li> <p>Proven strategic senior leadership of a Quality Organization for a Contract Manufacturer preferred within a commercial manufacturing setting.</p> </li><li> <p>Knowledgeable of regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply cGMP regulations and other international guidelines to all aspects of the position. Experience with regulatory inspections.</p> </li></ul>