Compliance Manager

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 as well as 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

•For area of specialization, work with internal customers and develop and execute strategic audit plans for the area

•Deputize for QA management within area of specialization

•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

•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

•Travel on assignment

•Liaise with Procurement and Operations regularly to ensure that the TPS qualification process runs smoothly

•Provide support to QA Management and Auditors for TPS audit activities

•Evaluate TPS processes for quality improvements

•Provide QA Management with updates regarding the qualification and requalification status of TPSs.

•Host/support Parexel Sponsor Audits and Inspections as needed

•Evaluate Sponsor Audit and Regulatory Inspection processes for quality improvements

•Provide training for Sponsor audit and Regulatory Inspection activities.

QualificationsSkills:

•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

•Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups

•Work independently and consistently in a fast-paced environment

•Ability to train new and existing less experienced QA members.

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.

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.