Director, Quality Systems and Compliance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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, and Data Integrity. 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, Supplier Management, Proactive Compliance and Data Integrity. 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.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.PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.