* Facilitation of professional development and career advancement of Quality Management staff
* Administrative supervision of Quality Management staff, jointly with Senior Director Quality Management
* Participation in recruitment of Quality Management (QM) staff
* Facilitation of initial and ongoing training of Quality Management staff
* Oversight of initial and ongoing training of PSI Operations employees in quality management topics
Quality Management:
* Facilitation of regulatory agency inspections of PSI
* Facilitation of regulatory agency inspections of PSI-managed trial sites, including follow-up
* Participation in hosting client/third party audits of PSI, including follow-up
* Oversight of CAPA investigations management
* Management of investigations of suspected research misconduct, jointly with Senior Director Quality Management
* Backup responsibility for review of draft Quality Systems Documents (QSDs), including newly developed and revised QSDs
* Backup responsibility for approval of Quality Systems Documents
* Oversight of vendor qualification
* Oversight of computer systems validation documentation review
* Oversight of the process of providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM matters
* May 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 plan
* Management of QA audits contracted to PSI
* Oversight 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
Qualifications:
* College or university degree
* MD, PharmD or degree in life sciences is a plus
* Minimum 7 years of experience in Clinical Research
* Minimum 5 years industry experience in the capacity of a QA auditor or equivalent
* Must have experience in planning, conducting and reporting all types of quality assurance audits
* Auditing experience in USA
* Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
* Team oriented with superior communication and interpersonal skills
* Strong time management, organizational, planning and presentation skills
* Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
* Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)
* Must be a reasonably effective public speaker
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