Director, Quality Management.

Vor 2 Tagen


Zug, Schweiz TN Switzerland Vollzeit

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  • 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 Responsibilities:

  • 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 regarding 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 PowerPoint, 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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