Director, Quality Operations & Qualified Person

Job Description

As part of the team at Thermo Fisher Scientific, we do meaningful work, that makes a positive impact on a global scale! Join our 120,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and enable the future of scientific advances. Our work enables the groundbreaking biopharma research, advances precision medicine and supports the innovation of advanced materials, such as next-gen batteries and semiconductors.

Position summary

The Director, Quality Operations will provide quality oversight to our Commercial (DPS) and Pharmaceutical Development Services (PDS) sterile operations ensuring full compliance of quality, customer, and regulatory requirements for all the filling lines, visual inspection, and packaging.

Overall Team: 125 colleagues

Key Responsibilities:

• To embrace the 4-I values of Integrity, Intensity, Innovation and Involvement by role modeling the values.
• To set strategy and direction for Quality Operations department to ensure continuous improvements regarding the cGMP compliance standards and to accomplish compliance in the most efficient way. Advise quality top management on issues that may affect the site and/or Thermo Fisher Scientific as a whole.
• To recruit, retain and develop an impactful Quality Operations Team, acting as a role model leader for the entire organization by creating positive work environments and inspiring a culture of feedback and inclusion
• To be responsible for product quality, compliance, conformance to quality requirements and specifications, and conformance to customer quality requirements. To Lead work teams such as quality on the floor, batch release, customer support.
• To drive accountability around site quality metrics across all functions and act as key contributor towards financial performance metrics and customer scorecard metrics.
• To collaborate in handling customer relationships via proactive risk mitigation, and effective communication
• To act as a Site Qualified Person, also leading and supporting the QP network in the site.
• To collaborate with industry-driving customers to design and recommend a proactive approach to meeting future industry and regulatory needs.
• To represent Quality Assurance in all Regulatory and Customer Inspections as well as compliance issues and on Quality Governance committees.
• To ensure efficient operations to support commitments to customers regarding product delivery and project results.
• To ensure adherence of Manufacturing and Packaging to regulatory requirements. Provide systems to maintain compliance with these requirements.
• To remain current in relevant worldwide regulations pertaining to manufacturing quality assurance. This includes working with key customers to recognize future customer and regulatory expectations.
• Create development plans for high potential colleagues and ensure department's growth and improvement over time
• To interact, negotiate and persuade management within different organizations, including internal organizations, customers and other external entities. The job holder must effectively blend the compliance of corporate quality standards with the quality requirements of customers.

Requirements:

• Bachelor’s degree in Physical Sciences, Engineering or related field required.
• 15+ years of cGMP experience in the pharmaceutical industry.
• Eligible to act as QP in Italy
• Sterile manufacturing experience is considered required for the role. CDMO experience is a strong plus.
• 10+ years in a leadership role, ideally in a international environment.
• Strong communication, influencing and change leadership skills.
• Ability to navigate successfully in a complex matrix organization and a complex business model (multiple lines/multiple products/ multiple customers).
• Analytical attitude and Critical thinking.
• Process orientation and optimization.
• Sense of urgency in a high intensity environment.
• Advanced communication and presentation skills; confidence in working directly with a wide range of international customers, senior internal stakeholders and regulators.
• Strong decision making skills.
• English and Italian fluency.

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.