Director, Quality Management

Summary

Join our dynamic global company as a Quality Management professional! This home-based position in the US requires some travel and involves resource management, training, quality management oversight, quality assurance auditing, and potential business development contributions. You will oversee staff, audits, and training programs, ensuring compliance with regulations. The role demands extensive experience in clinical research, quality assurance auditing, and a strong understanding of GCP guidelines and FDA/EMA regulations. Success requires excellent communication, organizational, and time management skills.

Requirements

• College or university degree
• 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 (including GCP investigator site audits and vendor 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

Responsibilities

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

Preferred Qualifications

MD, PharmD or degree in life sciences