When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
This position will provide strategic direction and lead the Fair Lawn and Bridgewater, NJ sites for Quality Assurance and ensure full compliance of regulatory requirements. The candidate will be a hands-on and insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive sustainable Quality process improvements. This customer facing role will require excellent interpersonal and communication skills in addition to attention to detail and a strong sense of urgency.
- Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement by role modeling the values.
- Development, implementation, and improvement of quality system policies and procedures supporting 21 CFR 820; ISO9001, cGMP and laboratory related compliance Standards/Regulations to meet customer expectations.
- Manage multi-site Quality Assurance team; , Quality Systems, Customer Complaints, CAPA, Change Control, QA Audit/Document Control teams; Provide regular mentoring, development, guidance and feedback.
- Work with operations to establish good manufacturing practices and improve quality culture.
- Lead and participate in cross functional teams in new product development, technology transfer, process improvement and general operations.
- Facilitate and participate in regular site product and process quality reviews including Management Review.
- Responsible for monthly site metrics (score card) presentation to Executive Management.
- Assist with investigations of process variance, nonconforming materials and complaints.
- Contribute to the development of the annual Quality Plan. Manage deliverables to key milestones.
- Chair the CAPA and Non-Conforming Materials Boards, coordinate/manage CAPA efforts and interact with customers (internal and external) on a timely manner and inform the customer periodically of progress relating to issued CAPA’s, conducts and or coordinates complaint investigations.
- Act as main contact during FDA inspections, Notified Body (Management Representative), customer audits and other third party Quality System evaluations.
- Position requires a 4-year degree in a technical/science area; an advanced degree is preferred.
- More than 7 years in an FDA regulated industry (Medical Device, Pharmaceutical, Biotech, Food) with 5 or more years in a people management position is also required.
- Significant hands-on experience with quality management systems implementation and improvement is also required. Incumbent must possess strong interpersonal, verbal and written communication skills and the ability to regularly present to Executive Management on key subjects.
- Certification as ISO 9001, 13485, GMP Lead Auditor a plus.
Critical Hiring Criteria:
- Proven experience as a Quality Manager in a multi-site role and the ability to manage and develop a large number of direct reports.
- Experience as a “champion for Quality”.
- Excellent organizational and time management skills.
- Excellent relationship building and persuasion skills with the ability to motivate and influence others.
- Excellent verbal and written skills to successfully communicate to a variety of internal and external audiences, while counseling, negotiating and formally presenting views and/or technical criteria.
- Must be skilled with a demonstrated record of overcoming resistance to change, and driving the adoption of new business processes from a position of direct and indirect/informal authority
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