Director, Corporate Quality Systems & Compliance

Hologic • Marlborough, MA

12h

About The Position

Hologic is committed to enabling healthier lives everywhere, every day—and
quality is central to that mission. As Director, Corporate Quality Systems &
Compliance, you will provide global leadership and oversight for our Corporate
Quality Management System (QMS), serving as the central hub for harmonizing
quality practices, standards, and expectations across all regions and divisions.

In this highly visible role, you’ll drive the development and continuous
improvement of enterprise-wide quality initiatives, ensure alignment with global
regulatory requirements and corporate objectives, and champion a strong, unified
culture of quality. You’ll embed quality principles into systems, training,
leadership behaviors, and daily operations—positioning quality as both a shared
responsibility and a strategic differentiator for the business.

Requirements

• In-depth understanding of QMS standards and frameworks and strong knowledge of regulatory and compliance requirements, including: FDA 21 CFR Part 820 GMP EU MDR and other regional regulations.
• Comprehensive understanding of QMS architecture: process mapping, procedures, work instructions, records, and their interdependencies.
• Knowledge of risk management methodologies (FMEA, risk matrices, hazard analysis) and integration into QMS processes.
• Familiarity with global quality governance models, including central vs. local responsibilities and harmonization across multiple sites/regions.
• Thorough knowledge of CAPA and nonconformance management, including root cause analysis and effectiveness verification.
• Understanding of continuous improvement methodologies and tools (Lean, Six Sigma, PDCA, Kaizen).
• Familiarity with electronic quality tools: eQMS, Document Management Systems (DMS), Learning Management Systems (LMS).
• Awareness of cross-cultural considerations in a global environment (communication styles, regulatory expectations, operational practices).
• Strong business acumen and understanding of how quality performance impacts customer satisfaction, operational efficiency, and financial results.
• Proven experience in developing and delivering quality training and leading multi-division quality initiatives.
• Ability to design, implement, and continuously improve QMS processes at an enterprise or multi-site level.
• Strong capability in interpreting regulatory and standard requirements and translating them into practical, effective procedures and controls.
• Expertise in leading CAPA and nonconformance investigations, including problem definition, root cause analysis (5 Whys, Ishikawa, 8D), risk assessment, and robust action plans.
• Ability to analyze quality data, define and monitor KPIs, and identify systemic issues and improvement opportunities across global operations.
• Demonstrated ability to lead and influence cross-functional, cross-site, and cross-cultural teams without direct authority.
• Skilled in designing, delivering, and evaluating quality training programs for diverse global audiences (in-person, virtual, e-learning).
• Strong change leadership and culture-building skills: able to articulate a vision for quality, gain buy-in, and drive behavioral change at all levels.
• Excellent stakeholder management and relationship-building skills with Operations, R&D, Regulatory, Supply Chain, HR, and regional/site leadership.
• Demonstrated commitment to continuous learning, staying current with evolving standards, regulations, and industry best practices in quality management.
• Strategic, visionary leader who can embed quality into strategic planning, decision-making, and daily operations.
• Acts as a champion for quality culture, promoting awareness, ownership, and continuous learning across all regions and functions.
• Collaborative and influential, building strong partnerships and driving alignment on global quality objectives and standards.
• Highly accountable, data-driven, and results-focused, with a strong orientation toward continuous improvement and proactive risk management.
• Effective communicator who can tailor messages for executive leadership, site teams, and global audiences, fostering open dialogue about quality performance.
• Bachelor’s degree in Science, Engineering, Quality Management, or a related field required.
• 10+ years of progressive experience in quality systems, regulatory compliance, or enterprise quality management.
• Significant experience leading cross-functional quality initiatives and compliance programs in regulated industries (medical devices, diagnostics, healthcare).

Nice To Haves

• Advanced degree (e.g., MBA, MS) preferred.
• Prior leadership in developing and executing quality compliance strategies at the corporate level strongly preferred.

Benefits

• We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

What This Job Offers

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