Principal Quality Assurance Auditor/Compliance Manager

Management/coordination/oversight of QA compliance GxP activitiesin a specific geographical and/or functional/specialist area :

• Lead and 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 clients.

• Promote compliance within the company and represent QA, as required.

• Review Parexel SOPs as assigned to ensure GxP compliance of processes

• Proactively re/review and oversee QA SOPs and be able to speak to their contents

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

• Contribute to the information provided to QA management to summarize quality issues arising from audits and other related activities, as requested.

• In liaison with the QA management matrix, manage tasks and initiatives, including teams of multifunctional personnel, as needed.

• Review the work of the matrix team to ensure consistency and quality within the group.

• Deputize for Sen Compliance Manager and QA management within area of specialization.

Work closely with Regulatory Authorities and Clients. Support regulatory inspections & client audits as needed.

• Provide consultation and interpretation on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP and safety/PV requirements, and implementation of appropriate regulatory requirements.  

• Act as a contact with members of Regulatory Authorities and / or clients; lead their audits / inspections in agreement with QA management.

• Act as key contributor for review of client audit/regulatory inspection findings.

• Provide strategic feedback and trending for Regulatory Inspectorates and client audits.

• Review and contribute to Requests for Information (RFI) as assigned.

• Conduct mock office inspections in agreement with QA management.

• 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 QA professionals.

Act as QA Lead for billable audit programs or client account for which QA representation is needed (as applicable)

• Oversee billable audit programs.

• Create and maintain the Audit Process Plan (APP) for the program.

• Coordinate billable audits across all regions.

• Act as main QA contact for the client and the Parexel project teams

• Request assignment of auditors by Parexel QA management.

• Provide auditors with the information required to schedule their assigned audits.

• Review audit reports and responses to ensure consistency in audit conduct, report writing and follow-up for the program.

• Raise a Change in Scope (CIS) if QA services outside of the APP are requested by the client.

• Maintain relationships with clients and ensure audits programs are managed to a high degree of client satisfaction.

• Support client QA needs and identify areas where billable services may be offered.

• Develop and optimize new and existing processes to maintain and improve quality within the billable group.

Lead and coordinate internal audits and  audit programs (global and regional)

• Plan and conduct complex/for cause audits as assigned across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier qualification and re-qualification audits (including GMP & GLP, as well as GCLP accreditation audits), safety/pharmacovigilance (PV) audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines.Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time. 

• Coordinate internal global process/system audits across regions and develop all necessary tools such as report templates, checklists and standard emails.Report outcome and trends of audit program to the process owner, QA Senior Management.Resolve program related issues in a constructive and pro-active way. 

• Escalate quality and compliance issue trends to QA Senior Management and relevant operational functions

• Review audit reports, responses and other audit and program deliverable to ensure consistent high quality

• Review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.

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

• Travel internationally for audits as required. Travel time could be up to approx. 60%.

Maintain QA records / systems

• Manage tasks or initiatives as assigned, including teams of multifunctional personnel, as needed.

• Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities.

• Maintain and / or develop records / documents for assigned areas.

Process Improvements

• Optimize new and existing processes to maintain and improve quality standards including supporting quality initiatives as assigned 

• Assist QA Management in the development and implementation of audit plan, strategic procedures and working practices to ensure continuous quality improvement.

• Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.

• Analyze audit activities and provide metrics to relevant parties (QA, Operations, Procurement).

• Proactively recognize areas for process / procedural improvements, providing input to QA management and taking the initiative, as appropriate.

Provide Trainings and Mentoring

• Develop and present training courses as needed.

• Train new and existing less experienced QA personnel.

• Train and educate operational staff by the development and presentation of training courses.

• Mentor new QA staff as assigned.

Build and maintain relationships

• Build, develop, and maintain good working relationships with internal and external customer groups.

• Work well in team environment.

• Liaise with clients and operational staff on quality aspects which may include attendance of meetings, presentations and audits

Perform other quality related task or initiativesas assigned

• Perform other quality related tasks or initiativesas assigned.

• Provide Quality representation on Serious Breach Assessments

• Support and assist with Information Security Incidents and technology related policies and procedures

• Other duties as assigned.