Are you an experienced Quality leader with a passion for compliance and driving impactful change? Hologic is seeking a Global CAPA and Compliance Manager to oversee and ensure a robust and compliant CAPA and Nonconforming process. This role is also pivotal in championing continuous improvement initiatives and maintaining alignment with regulatory standards across global platforms.

As a global process owner, you will act as the subject matter expert in CAPA and Nonconforming processes, supporting the organization with your in-depth knowledge of Root Cause Analysis tools, risk management, and Quality Management Systems. In addition, you’ll oversee key management controls like Quality Planning and Corporate Management Review, while facilitating global CAPA Review Board meetings to identify trends and drive improvement.

Knowledge

Comprehensive understanding of CAPA (Corrective and Preventive Action) and Nonconforming processes. Expertise in Root Cause Analysis tools and application of risk management to Quality Systems. Familiarity with global regulatory standards such as 21 CFR Part 820 and ISO13485. Awareness of emerging regulations and standards impacting quality systems. Expertise in Quality Planning and Management Review processes.

Skills

Strong project management skills, with the ability to oversee tasks, timelines, and deliverables effectively. Advanced proficiency in the Microsoft Office suite. Exceptional written, verbal, and presentation skills to communicate with all levels of the organization. Exceptional attention to detail and organization skills.

Behaviors

Proactive and results-driven mindset, always seeking opportunities for continuous improvement. Collaborative team player with excellent interpersonal skills to interact with diverse stakeholders. Adaptable and resilient in dynamic, fast-paced environments.

Experience

Minimum 5 years in a regulated environment under 21 CFR Part 820 and ISO 13485. Hands-on experience with Quality Management Systems and continuous improvement initiatives. Proven track record in project management, including stakeholder communication and timely delivery. Experience supporting audits and regulatory inspections.

The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.
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 $102,600-$171,000 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 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.

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

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