Director Quality

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

As Director of Quality and Compliance , you will be responsible for taking a transformative approach to leading a dynamic and high-functioning Quality Assurance team at the Thermo Fisher Scientific, Clinical Diagnostics Division site in Middletown VA 

The successful candidate will be responsible for raising the bar in process and culture across all aspects of quality system and compliance at the location, which performs development and manufacture of IVD products in adherence to applicable global regulations and standards such as US FDA QMSR, IVDD / IVDR, ISO13485:2016 (under MDSAP) and other GMP standards.

You will have responsibility for advising and collaborating with Manufacturing, Technical Operation and Commercial functions on quality and quality system requirements to ensure activities remain in compliance, and for driving continued evolution of the Quality function and site quality system to ensure it remains adequate to business needs and is successfully implemented.

This is a highly visible role at the site and Division level and, as a key member of the leadership team, you will report to the CDD Vice President, Global Quality Assurance & Regulatory Affairs.

A critical aspect of this role is serving as the primary quality representative for customers and regulatory authorities. As the site's Management Representative, the Director is responsible for ensuring the effectiveness of the Quality Management System and leading interactions during FDA inspections, MDSAP and ISO 13485 audits, and customer audits. This role requires strong leadership and communication skills to build customer confidence, maintain regulatory compliance, and represent Thermo Fisher Scientific with credibility and professionalism.

Key Responsibilities:

• Acts as Management Representative of the Quality System and official correspondent of the site to all regulators (including US FDA). Primary contact at the site for all audits (regulator, Notified Body and customer). 

• Serve as a member of the site leadership team, providing strategic direction and influencing business decisions to ensure quality, compliance, and operational excellence are integrated into site objectives.

• Establish strategies and drives actions to ensure the Quality Management System is adequate and successfully implemented to remain in sustained compliance with applicable regulations and standards.

• Responsible for site product quality, compliance, conformance to quality requirements and specifications, and customer quality requirements. Supports regulatory recalls and interaction with government agencies.

• Directly interacts with customers and OEM partners in relation to quality agreements, and quality matters associated with provided products and services.

• Champion risk-based decision making by overseeing quality risk management processes and ensuring risks are identified, assessed, mitigated, and monitored throughout the product lifecycle.

• Attracts, develops, and retains top talent to build an outstanding quality / regulatory function. Implements the required interpersonal structures and operating mechanisms to maintain appropriate oversight of the compliance status of the business and achieve results.

• Grows and develops a customer-focused culture of personal quality in all site functions through leading, educating, and motivating site personnel using industry-leading practices.

• Establishes and leads annual personnel resource and financial plans for the quality / regulatory organization.

• Establishes annual site quality goals and objectives as part of annual Quality Improvement Plan and develops strategies and tactics to deliver associated results.

• Leads and participates in cross functional teams for new product development, technology transfer, process improvement, and general operations.

• Partners with regulatory affairs in all aspects of site regulatory processes that ensure the appropriate licensing, marketing and legal compliance of all appropriate diagnostics and medical device products globally.

• Collaborate with global Quality and Regulatory leadership to standardize best practices, share lessons learned, and support enterprise quality initiatives.

Minimum Requirements/Qualifications:

• A minimum of 10 years of quality / regulatory experience including at least 5 years of prior experience leading a quality / regulatory role. 

• Undergraduate degree in life science or biomedical engineering-related subject area preferred.

• Strong demonstration of leadership capabilities required, with experience in driving organization and process change. Experience in leading transformations is preferred.

• Strong solid understanding of QMS standards and medical device requirements/regulations (ISO 13485:2016 (preferably under MDSAP), US FDA QMSR, Health Canada, IVDD / IVDR)

• Experienced in direct, professional interactions with customers and OEM business partners and regulatory authorities.

• Ability to achieve results in a matrixed organization, using representatives from diverse cultures and embracing diversity.

Travel requirement:

• <10% regional and international travel is expected.

Compensation and Benefits

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

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