Resource Management and Training:
- Participation in QM resource allocation
- Resource allocation of QA auditors
- 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
- 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 of 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
All your information will be kept confidential according to EEO guidelines.
