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Compliance Manager Billerica United States,  

Parexel (company)


Posted on : 13 June 2019

Project Description


The Compliance Manager will have a primary role in the management/coordination/oversight of QA compliance GxP activities in a specific geographical and/or functional/specialist area, as assigned by QA Senior Management. Alternatively, or in addition, the Compliance Manager can act as the QA Lead / QA Lead back-up for a Strategic Partnership or a client account for which QA representation is needed. Other duties may include the Auditor Coordinator role, as assigned.

Key Accountabilities:

  • Work independently and as part of the QA team
  • Act as expert GxP consultant in relevant area to groups within the PAREXEL organization and PAREXEL sponsors
  • Train new and existing QA personnel
  • Train and educate operational staff by the development and presentation of training courses
  • In liaison with the QA management, promote compliance within the company and represent QA, as required
  • Build, develop, and maintain good working relationships with internal and external customer groups
  • For area of specialization, work with internal customers and develop and execute strategic audit plans for the area
  • In liaison with the QA management matrix, manage projects, including teams of multifunctional personnel, as needed
  • Review the work of the matrix team to ensure consistency and quality within the group
  • Act as a contact with members of Regulatory Authorities and / or sponsors; help lead in their audits / inspections in agreement with QA management
  • Contribute to the information provided to QA management to summarize quality issues arising from audits and other related activities, as requested
  • Plan and conduct complex audits / mock office inspections in agreement with QA management
  • Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
  • Assist QA management in the development and implementation of strategic procedures and working practices to ensure continuous quality improvement
  • Maintain relevant knowledge of both local and international auditing and appropriate GxP requirements and developments as they impact PAREXEL’s international SOPs and compliance with GxP, and communicate these to the QA team and QA management, as applicable
  • Be familiar with GxP required computer system validation requirements
  • Maintain and / or develop records / documents for assigned areas
  • May serve as a member of industry association boards, task forces, and committees and / or as chairperson or officer of one or more professional associations.
  • Contributes expertise to professional societies, academic, or other similar groups influential in his / her area of expertise
  • Develop and maintain network contacts with other quality assurance professionals
  • Travel on assignment

Qualifications

Skills:
  • Ability to develop relationships with a culturally diverse group of key stakeholders within PAREXEL and the client’s business
  • Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions
  • Experience with Microsoft based applications and ability to learn internal computer systems
  • Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Ability to work flexibly and adjust to changing priorities and unforeseen events
  • Diplomatically address sensitive issues confidentially and professionally
  • Excellent knowledge of, and working experience with, relevant national / international regulations
  • Lead team / project to successful conclusion

Knowledge and Experience:
  • Extensive experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing

Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related
  • discipline preferred) or equivalent qualification or clinical research experience
  • Master’s degree in a science, technology or industry related discipline, preferred

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Locations

Billerica, Massachusetts, United States

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