Job DescriptionThe Senior Manager, Quality and Change Management is responsible for providing leadership and strategic oversight for Global Quality Management System (QMS) activities at Hologic.
This role ensures effective governance, compliance, harmonization, and continuous improvement of key QMS processes, including Document Control, Change Control, Management Review, Quality Planning, and Management Responsibility. The position involves managing a team, driving quality initiatives, and ensuring alignment with regulatory and corporate standards.
Knowledge- In-depth understanding of quality management systems, especially in the medical device or related industry
- Strong knowledge of applicable regulations and standards, particularly ISO13485 and 21CFR Part 820
- Familiarity with the Hologic Corporate Quality Manual and corporate procedures
- Awareness of international and domestic regulatory requirements
Skills- Strong communication, presentation, and facilitation abilities
- Project management proficiency
- Leadership capabilities, including coaching and developing direct reports
- Proficiency in product lifecycle management (PLM) tools and Microsoft Office Suite
Behavior- Demonstrates strategic leadership and ownership of assigned QMS processes
- Promotes a culture of quality, compliance, ownership, and continuous improvement
- Maintains effective communication with global stakeholders and ensures harmonization across sites
- Acts as an escalation point for complex or high-risk issues, ensuring appropriate resolution and management visibility
Experience- Bachelor's degree in engineering or a science-related discipline (or equivalent combination of education and experience)
- 8-10 years of progressive quality experience in the medical device or related industry
- Minimum 5 years of supervisory experience preferred
The annualized base salary range for this role is $134,700 - $224,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter NoticeAgencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
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