Director, Quality Management System & Compliance

Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP)

Safety Standards, Cleanroom:

no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift 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. The Director, Quality Systems & Compliance will provide oversight and ensure full compliance of quality, customer, and regulatory requirements for Quality Systems, Audits/Inspections, QA Validation, Data Integrity and Training. Driving best-in-industry as it relates to continuous improvement by growing quality, compliance and efficiency standards. This role specifically includes providing comprehensive quality oversight for customers with high value products. As a member of the Quality Management Team, this role advises on quality and regulatory issues.

Key Responsibilities:

Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement by role modeling the values. Responsible for product quality, compliance, conformance to quality requirements and specifications, and conformance to customer quality requirements.

Leads multiple functional work teams such as Quality Systems, Audits/Inspections, QA Validation, Data Integrity and Training. Contribute to establishment and delivery of site quality metrics, financial performance metrics and customer scorecard and satisfaction metrics. Set strategy and direction for handling key customer relationships; including proactive risk mitigation, right first time, regulatory trends, etc. Collaborating with industry-driving customers to design and recommend a proactive approach to meeting future industry and regulatory needs. Set strategy and direction to ensure continuous improvements regarding the most recent national and international 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. Represent the site in all Regulatory and Customer Inspections as well as compliance issues. Ensure efficient operations to support commitments to customers regarding product delivery and project results. Represent Quality Systems & Compliance on Quality Governance committees. Ensure adherence to all relevant worldwide regulatory requirements. Provide systems to maintain compliance with these requirements. Remain current in relevant worldwide regulations pertaining to operations and quality assurance. This includes working with key customers to recognize future customer and regulatory expectations. Develop technical, supervisory and managerial staff to improve personal and site performance. Build developmental plans for high potential staff. Work closely with operations to establish and promote good manufacturing practices and improve quality culture. 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.

Qualifications:

Bachelor's degree in Physical Sciences, Engineering or related field required. 10+ years of cGMP experience in the pharmaceutical industry with at least 5 years of Quality Systems & Compliance experience required. 8+ years in a leadership role, committed to employee engagement and development required. Strong demonstration of leadership capabilities required, with experience in influencing at distance and driving organization and process change. Experience in leading a compliance turnaround program preferred. Experience in CDMO/pharmaceutical contract manufacturing environment preferred Advanced cGMP experience required. In depth knowledge of pharmaceutical contract manufacturing, Quality Assurance, Compliance, Quality Control and Regulatory Affairs. Must be able to interact with and influence the most senior levels of the organization. Advanced problem-solving skills and comfortable working directly with our valued customers to determine solutions. Strong communication, persuasion, and presentation skills. Advanced change management skills are vital. Experienced in direct, professional interactions with customers and internal business partners. Ability to achieve results in a matrixed organization, using representatives from different cultures and embracing diversity. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 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.