Junto HLS is working directly with Leadership at a Top 20 pharma to recruit a Head, (GCP/GVP/GMP) Research and Development Quality Systems.
- Provides R&D global leadership and strategic direction for R&D Quality Systems across Quality Architecture, Documentation and Training, and Quality Performance.
- Leads the R&D Quality Architecture function, and fulfils the following key deliverables:
- Provides regulatory and technical expertise and leads the development of R&D procedures and supporting documents, ensuring alignment with Global Quality organizing principles and the R&D business.
- Interprets new regulations and incorporates as appropriate in the R&D processes.
- Ensures R&D procedures and supporting documents are aligned with Global Quality and are in a state of compliance.
- Sets and maintains clear requirements for procedure format, content level, and logical document hierarchy.
- Oversees the receipt, investigation, and resolution of non-medical complaints, and engages Global Patient Safety Evaluation for medically related complaints.
- Ensures that regulatory and other CAPA commitments are met.
- Leads investigations (excluding those relating to Scientific Misconduct) and manages deviations.
- Leads the Documentation and Training function of R&D, fulfilling the following key deliverables:
- Develops training strategy for R&D to promote agility and respond to the needs of an evolving R&D organization.
- Ensures that training delivery methodologies are appropriate to the process or topic.
- Ensures that training matrices are appropriate.
- Monitors training compliance, generates metrics for R&D and R&D Quality leadership, and intervenes to improve compliance when needed.
- Leads the R&D Quality Performance function, fulfilling the following key deliverables:
- Provides metrics and KPIs to improve quality and promote compliance with health authority requirements and company’s expectations..
- In collaboration with the functional R&D Quality leads, organizes and leads functional Quality Councils.
- Participates as a key member of the R&D Quality Management Team
- Meeting biweekly and face to face quarterly, participates on the R&D Quality Management Team responsible for the oversight of Quality for R&D.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.