Director, Quality

Work Schedule

Environmental Conditions

Job Description

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 outstanding 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.

Clinical Trials Division (CTD) collaborates globally with pharmaceutical and biotech clients to deliver precise patient care solutions.

Position Summary: We have an exciting opportunity for a Director, Quality to join the growing Allentown, PA site as the Site Quality Head! Quality organization and all Quality related programs and activities to support site operations for clinical and commercial manufacturing, packaging & labeling and distribution. This role ensures business, quality and compliance goals are met and policies, standards, and relevant government issued quality and regulatory policies and guidelines.

• Establishing and leading current and long-range objectives and activities in accordance with policies, goals and objectives established by the Senior Quality Director, Americas and CTD Leadership team.
• Providing leadership, enablement, and direction to the Quality team to ensure that the Quality Management System is fulfilling the regulatory and business needs for the site.
• Ensure each batch of medicinal product meets local, regional, national, and international laws.
• Effective strategy, monitoring, and maintenance of the Quality System, including qualification, maintenance of premises and equipment, and ensuring appropriate validations are done.
• Lead the Quality Unit, set goals, and guide health authority inspections and regulatory awareness programs.
• Supporting the business development and commercial functions by ensuring Quality is a service differentiation for FCS globally.

• B.S. in a scientific/technical field with proven track record within the pharmaceutical industry. 5-10 years experience leading teams.
• Effective interaction abilities both internally and externally, understanding clients' needs and developing suitable solutions.
• Proven strategic senior leadership of a Quality Organization for a Contract Manufacturer, preferably within a commercial manufacturing setting.
• Knowledgeable of regulatory requirements applicable to pharmaceuticals and ability to apply cGMP regulations and other international guidelines to all aspects of the position. Experience with regulatory inspections.

• Ability to work in an office and manufacturing environment.
• Occasional travel may be required.