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Global CAPA & Compliance Manager

United States

The Global CAPA and Compliance Manager will lead the organization as a Quality leader overseeing and ensuring Hologic has a robust and compliant CAPA and Nonconforming process. Responsible for facilitating various quality system related meetings and identifying continuous improvement opportunities within the CAPA and NCE process/system and monitoring to completion. This role will include oversight of the Corporate Management Review process and Quality Planning to support continuous improvement initiatives across global platforms and processes.

What To Expect:

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

• Act as the global process owner for CAPA and Nonconforming processes for Hologic

• Global subject matter expert on CAPA and non-conforming processes with an in-depth knowledge of Root Cause Analysis tools and application of risk management to CAPA and the Quality Management System

• Support oversight of Management Controls such as Quality Planning and Management Review

• Oversee the department Regulatory Intelligence items to ensure alignment to new and upcoming regulations and standards

• Coordinates global CAPA Review Board Meetings to analyze trends and drive continuous improvement initiatives

• Manage vendor relationships for CAPA training creation and updates

• Reviews and approves CAPA documentation to ensure completion of activities and compliance with good documentation practices

• Responsible for facilitating regular SME meetings to share metrics, best practices, and process improvements. Develop action plans as appropriate to maintain performance and continuous improvement

• Responsible for maintaining procedures and training material in compliance with internal and external requirements for the applicable areas of responsibility

• Supports the process to gather and communicate quality systems Key Performance Indicators across the organization

• Ensures timely completion of projects assigned within budget and audits the effectiveness of projects ensuring business objectives have been achieved

• Accountable to provide support for internal and external audits as required

• Manages communication around project expectations with users; provide overall project status updates to stakeholders

• Responsible for conducting investigations and drive corrective actions to address compliance issues related to the areas of responsibility

Supervisory Responsibilities:

• Fulfills supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training, and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

What We Expect:

• BS/MS degree or equivalent certification. Equivalent combination of education and practical experience acceptable.

• Minimum 5 years’ experience working in a regulated environment under 21CFR Part 820 and ISO13485 including Quality Management System experience

• Project Management experience

Skills Required:

• Strong working knowledge of Microsoft Office suite

• Excellent written, verbal and presentation skills

• Excellent interpersonal skills to interact with all levels of the company and oversight agencies

• Strong attention to detail and excellent organization skills

• Knowledge of the meaning, spelling, and use of the English language

Travel:

• Travel expectations: up to 25%.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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 $101,000 to $168,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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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