What are the responsibilities and job description for the Director Quality Management position at PSI CRO?
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 PSImanaged trial sites including followup
Participation in hosting client / third party audits of PSI including followup
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 multitask / be flexible and thrive in a fastpaced 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.
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