Director, Corporate Quality Systems & Compliance

Hologic is committed to enabling healthier lives everywhere every dayand 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 youll 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. Youll embed quality principles into systems training leadership behaviors and daily operationspositioning quality as both a shared responsibility and a strategic differentiator for the business.

Knowledge

• 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.

Skills

• 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.

Behaviors

• 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.

Experience

• Bachelors degree in Science Engineering Quality Management or a related field required. Advanced degree (e.g. MBA MS) preferred.
• 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).
• Prior leadership in developing and executing quality compliance strategies at the corporate level strongly preferred.

Why join Hologic

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.

The annualized base salary range for this role is $158000-$280900 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 Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource 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.

Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

#LI-NT1