Job Title: Site Quality Head
Requisition ID: 114171BR
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
High Point, NC USA / Drug Product
How will you make an impact?
The Site Quality Head will successfully manage and direct the activities of the Quality Assurance, Quality Compliance, Quality Support, Quality Control and Microbiology departments of the High Point facility. This position requires an experienced and entrepreneurial leader that will develop Quality strategy, make decisions based upon relevant data and Good Manufacturing Practices (GMPs). This position will hold the site and team responsible for meeting commitments and enhancing customer experience.
What will you do?
Responsible for the management and supervision of Quality Assurance by assisting in the development of goals and key performance indicators, providing leadership for Food and Drug Administration (FDA) audits as well as regulatory awareness programs for each agency, assisting with the FDA and other audit response teams and assisting in the development of Good Manufacturing Practices (GMPs) for all departments.
Organize key staff elements and direct Quality Assurance and Quality Control functions to achieve site goals and customer expectations while maintaining compliance to corporate standards and the various regulatory agencies around the world.
Directly maintain Food and Drug Administration (FDA) / Medicines and Health Products Regulatory Agency (MHRA) and other agency compliance statuses
Active & collaborative member of the site leadership team, operational leadership team, and support the management team where required.
Ensure that all parties interacting with technical support are aligned in shared tactical & strategic approaches.
Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
Provide technical support to pharmaceutical sales, client sales, Pharmaceutical Development Services (PDS), Operations and individual client groups.
Interact with key Patheon clients and provide resolution to customer issues and concerns.
Select, manage and develop the Quality Operations staff to ensure the efficient and effective operation of the Quality function.
Establish the strategic plans and objectives for the site Quality organization by making final decisions on administrative and operational matters against Company Quality standards.
How will you get here?
Minimum of 7-10 years of Senior Quality Leadership experience is required
Pharmaceutical manufacturing (cGMP) experience is required
Oral solid dose and/or Soft Gel pharmaceutical manufacturing experience is preferred
Knowledge, Skills, Abilities
Well-developed change management abilities and skills are required
Excellent people management and development skills are required
Must be able to interact with and influence the most senior levels of the organization
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 EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific Inc.