Greenville, NC, 27835, USA
16 hours ago
Sr Director, Quality CTD
**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **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 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 . **Position Summary:** The Sr. Director Quality, Clinical Trial Division (CTD) Americas is a senior level leadership role responsible for providing leading services in Quality to ensure safe and compliant management of CTD. CTD Americas comprises of facilities across North and Latin America, offering unmatched planning, manufacturing, packaging, storing, and distribution expertise. Responsible for the compliant supply execution of CTD Comparators globally. Ensure that the important supplies needed by our customers are manufactured safely for our patients around the world. Ensuring our products are handled and delivered in a compliant manner, with the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. Full direct operating control of Quality for each site and lead a team of approximately 160 people across a variety of Quality sub functional roles. Foster world class quality, promote a GXP culture and assure regulatory compliance. Customer engagement is key to the success of CTD Americas and requires direct communication to be involved in the process, and to increase brand awareness and loyalty. Engagement and drive customer queries on a Global level, handling escalations accordingly. **Key Responsibilities:** Advising Quality operations regionally to support Regional and Business leaders to drive budgeted profit results, establishing objectives and steps are taken to put preventative actions in place. Lead all aspects of Quality functions with direct management of Americas Site Heads of Quality. Establish, direct, administer and coordinate current and long range objectives and activities in accordance with policies, goals and objectives established by the VP Quality, CTD and CTD Active Vice- President. Member of the Americas leadership team. Maintaining positive company image and positive relationships with key customers, vendors and regulators. Involved with the management of key accounts and will represent the company in its relationships with external entities. Developing and maintaining a robust divisional quality plan; establishing policies to ensure exceptional management development and provide capable management succession in Quality. Emphasizing the critical need for on-time delivery through the lens of full compliance; driving this focus across all levels of the organization. Leading all company activities in compliance with quality system regulations as required per Americas country GXP standards, and other regulatory entities, ensuring division participation and compliance; + Ensuring that the division operations follow all applicable laws and regulations, including EU-OSHA. + Insuring all licenses and permits from local authorities, government agencies are obtained and maintained to ensure uninterrupted company operations. + Ensuring PPI (Practical Process Improvement) is embraced. + Formulating and implementing quality policies, procedures and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation. + Ensure a robust audit mechanism is established globally. + Building rapport with workforce to promote quality and safety, ensure productivity and develop high morale! **Qualifications:** B.S. Degree in business, scientific or technical field. Advanced degree such as MBA or Masters preferred. 10+ years experience. Experience in a heavily regulated manufacturing environment. Ability to translate business demands into an operational quality plan. Ability to quickly create deep connections with customers. Understanding and ability to adhere to quality standards and regulatory compliance requirements. Experience at team building, coaching and mentoring all levels of the organization. 20% global travel. **Compensation and Benefits** The salary range estimated for this position based in North Carolina is $175,100.00–$233,500.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: + A choice of national medical and dental plans, and a national vision plan, including health incentive programs + Employee assistance and family support programs, including commuter benefits and tuition reimbursement + At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy + Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan + Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards 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.
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