Director, Quality Management.

Job Description

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

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

Additional Information

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