Director, Quality Management

PSI CRO

Durham , United States

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 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