Thermo Fisher Scientific Sr. Quality Manager/PM BPG in Logan, Utah
Job Title: Sr. Quality Project Manager
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
This role can be based remotely. There will be approx. 30% - 50% travel to various BPD sites as needed (domestic and international destinations).
How will you make an impact?
We are looking for a self-driven, resourceful Senior Quality Manager/PM with up-to-date knowledge, and demonstrated experience driving and sustaining improvement to the Quality Management System to ensure compliance to all applicable standards and regulations (21 CFR Part 820, MDR, IVDR, ISO 13485, and ISO 9001 standards).
What will you do?
Manages to ensure the QMS processes are updated in compliance with applicable regulations and standards (MDR, IVDR, 21 CFR 820, ISO 9001, and ISO 13485).
Manages to strengthen and harmonize key Quality Systems processes across BPD sites (Management Review, Change Control, Complaint management, CAPA, NPI).
Shares audit results and best practices to drive proactive change within all sites. Assist with Site Audit Readiness activities
Liaises with group-level supplier management function to ensure Supplier Management process is compliant.
Monitors all reports of non-compliance resulting from customer, registrar and regulatory audits to ensure corrective action plans are in place.
Manages to ensure sites key procedures are in alignment with divisional and corporate quality guidance documents.
Collaborates with Divisional and Group resources to plan and execute on strategic multi-year IT systems roadmap for all BPD sites and work with site staff to ensure successful implementation.
Drives improvement and harmonization of internal audit program for all BPD sites, including but not limited to ensure that BPD sites have certified and competent internal auditors.
Manages to ensure review boards for key QMS processes are implemented and fully operational across all BPD sites and at the business unit and Divisional level. This includes key quality metrics and other projects as needed
Manages to ensure all sites follow Leader Standard Work on communication - Regulatory inspections & notified body audits are communicated upon notification, daily status updates are provided, and final closure.
Manages to ensure that training resources are available for BPD site QA personnel and personnel is trained to applicable regulations MDR, IVDR, 21 CFR 820, 21 CFR part 11, and standards ISO 13485, ISO 9001).
Ensures information impacting QMS processes is cascaded appropriately throughout organization.
Ensures Management is informed in a timely manner of changes / trends in the Quality Management System regulations and standards impacting BPD.
Assists with internal and external audit support (i.e. travel or virtual).
How will you get here?
- Bachelor's degree in related field, or consideration of an equivalent combination of education and experience
Minimum 7 years' experience with multi-site Quality Systems management
Global quality experience
Working experience with ISO 13485 and compliance with Medical Devices (MDR, FDA 21 CFR Part 820)
Lead Auditor Certification (ISO 13485) preferred
ASQ certification preferred
Program/Project management (multisite) experience preferred
Knowledge, Skills, Abilities:
Well organized and structured
Previous management-level experience required - experienced in managing through others in a matrixed organization
Ability to effectively lead, manage, train and motivate a diverse group of employees
Ability to manage multi-site projects and initiatives
Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.
Ability to use some or all of the following PC applications: Word, Excel, PowerPoint
Able to operate on multi time zone
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 productivity in their laboratories, we are here to support them. Our global team of more than 75,000 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 and Patheon. For more information, please visit www.thermofisher.com .
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.