Sr Manager, Quality and Change Management

Hologic•Marlborough, MA

8h•$134,700 - $224,500

About The Position

The 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.

Requirements

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
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
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

Nice To Haves

Minimum 5 years of supervisory experience preferred

Responsibilities

Providing leadership and strategic oversight for Global Quality Management System (QMS) activities.
Ensuring effective governance, compliance, harmonization, and continuous improvement of key QMS processes (Document Control, Change Control, Management Review, Quality Planning, Management Responsibility).
Managing a team.
Driving quality initiatives.
Ensuring alignment with regulatory and corporate standards.
Demonstrating strategic leadership and ownership of assigned QMS processes.
Promoting a culture of quality, compliance, ownership, and continuous improvement.
Maintaining effective communication with global stakeholders and ensuring harmonization across sites.
Acting as an escalation point for complex or high-risk issues, ensuring appropriate resolution and management visibility.