Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Resource Management and Training:

Participation in QM resource allocationResource allocation of QA auditorsFacilitation of professional development and career advancement of Quality Management staffAdministrative supervision of Quality Management staff, jointly with Senior Director Quality ManagementParticipation in recruitment of Quality Management (QM) staffFacilitation of initial and ongoing training of Quality Management staffOversight of initial and ongoing training of PSI Operations employees in quality management topics

Quality Management:

Facilitation of regulatory agency inspections of PSIFacilitation of regulatory agency inspections of PSI-managed trial sites, including follow-upParticipation in hosting client/third party audits of PSI, including follow-upOversight of CAPA investigations managementManagement of investigations of suspected research misconduct, jointly with Senior Director Quality ManagementBackup responsibility for review of draft Quality Systems Documents (QSDs), including newly developed and revised QSDsBackup responsibility for approval of Quality Systems DocumentsOversight of vendor qualificationOversight of computer systems validation documentation reviewOversight of the process of providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM mattersMay act as the primary QM contact for PSI Operations divisions and working groups/task forces with regard to various Corporate projects requiring QM

Quality Assurance Auditing:

Development and implementation of the annual audit planManagement of QA audits contracted to PSIOversight of the preparation and maintenance of internal and contracted quality assurance audits documentation

Business Development:

May be recruited by Business Development for client meetings and vendor shows

QualificationsCollege or university degreeMD, PharmD or degree in life sciences is a plusMinimum 7 years of experience in Clinical ResearchMinimum 5 years industry experience in the capacity of a QA auditor or equivalentMust have experience in planning, conducting and reporting all types of quality assurance auditsAuditing experience in USAExcellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulationsTeam oriented with superior communication and interpersonal skills Strong time management, organizational, planning and presentation skillsDemonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environmentIntermediate proficiency in MS Office (Word, Excel Power Point, Outlook)Must be a reasonably effective public speaker

Additional Information

All your information will be kept confidential according to EEO guidelines.