Hologic Director, Corporate Quality Compliance in Marlborough, Massachusetts

Director, Corporate Quality Compliance

Post Date May 08, 2018

Job Summary

The Corporate Compliance Director will define, implement, lead, and monitor the requirements of the Internal Audit Program across Hologic. Responsible to assess compliance and the effectiveness of the Hologic Quality System against global internal and external regulatory requirements, policies and procedures as applicable.

Responsible to monitor and analyze regulatory agencies and notify bodies trends and communicates internally to drive proactive plans and strategies.

Essential Duties and Responsibilities

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

  • Champion for the internal audit community across Hologic.

  • Acts as Internal Audit Process Owner. Develops and mentors internal auditors across sites.

  • Responsible for documenting, scheduling, planning, conducting, and reporting corporate audits of sites quality management system activities to assure compliance with applicable global regulatory requirements, and corporate policies and procedures.

  • Identifies, accesses and analyses all the internal and external data streams that have impact on the company's compliance to overall quality systems. Integrates such data and distils it into a clear, current and accurate state of compliance. Strategically leverages such information to proactively design a robust internal audit program. Is able to make recommendations based on areas of highest compliance risk.

  • Connects well globally to understand changes in regulatory environment worldwide, as it relates to the quality systems, and adjust audit plans and approach accordingly. Is able to identify audit trends and anticipate future audit focus.

  • Responsible for timely completion of all corrective actions and non-conformance’s related to the corporate internal audit process and areas of responsibility.

  • Provides periodical reports on the Key performance indicators for the internal audit process.

  • Responsible for developing and facilitating internal audit related trainings to support and maintain auditor’s qualifications.

  • Provides summary of internal audit results, and associated recommendations, for Executive Management Review as required by established procedures.

  • Assess compliance of processes and systems against applicable regulations and internal SOPs, etc.

  • Professionally communicates audit observations to the appropriate Management.

  • Leads team and internal audit community in continuous improvement and lean efforts.

  • Assists and participates in third party audits.

  • Serve as an internal consultant by providing guidance and meaningful interpretations of applicable regulations to the internal auditors and quality teams.

  • Conducts training related the internal audit process and external regulatory changes.

  • Conducts gap assessments and develop plans to meet new and or emerging regulatory changes to ensure compliance with statutory dates.

  • Provides guidance and when required approval regarding quality strategies and approaches.

  • Responsible for the development and tracking of the after action plan or lessons learned program to ensure proactive communication and actions based on third party audit results.

  • Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.

  • Assists in and/or completes the development of budgets and monitors spending.

  • Assists in identifying and developing department tools.

  • Assists in and/or determines appropriate staff levels, schedules and resources. Works with managers to understand priorities and plan resource and time allocation accordingly.

  • Maintains and enhances cross-functional team relationships.

  • Works cross-functionally in identifying and resolving technical issues.

  • Monitors and evaluates project and department progress and results.

Qualifications

Education

  • Bachelor's degree in Life Sciences, Engineering, Medical or related field

  • Lead auditor certification

  • ISO13485:2016 training

Experience

  • 8+ years of quality systems and GMP experience in the medical device, pharmaceuticals, or comparable environment

  • Skills

  • Comprehensive working knowledge of the FDA Code of Federal Regulations (21 CFR 820), applicable ISO standards (e.g., ISO 13485:2016, ISO 14971), MDSAP and other key relevant global regulations. Excellent verbal / written communication, interpersonal, and organizational skills; must be able to multi-task, assimilate, and analyze information quickly

  • Computer skills required are MS Word, Excel, MS Outlook, and general database experience.

Must follow all applicable FDA regulations and ISO requirements.

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.