Sr Manager, Quality and Change Management

Hologic • Marlborough, MA

2d

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

• 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.
• 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.
• 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.

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.

Benefits

• Comprehensive training when you join.
• Continued development and training throughout your career.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager