Manager, GCP/GVP Quality and Compliance en Systimmune
Systimmune · Princeton, Estados Unidos De América · Onsite
- Senior
- Oficina en Princeton
The Manager, GCP and GVP Quality & Compliance is responsible for supporting and maintaining quality and compliance programs to ensure adherence to global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations, guidelines, and company standards. This role will partner cross-functionally with Clinical Operations, Drug Safety/Pharmacovigilance, Regulatory Affairs, and external vendors to ensure inspection readiness, regulatory compliance, and continuous improvement of quality systems.
Key Responsibilities
Key Responsibilities
- Ensure GCP/GVP activities are conducted in accordance with applicable global regulations (e.g., EMA, FDA, ICH).
- Contribute to the development, review and maintenance of clinical, pharmacovigilance and quality/compliance related SOPs.
- Plan, oversee and/or conduct GCP/GVP internal and external audits.
- Collaborate with cross-functional teams to investigate and manage GCP/GVP-related quality issues, deviations and CAPAs.
- Perform Quality Monitoring (QM) of safety reports to ensure completeness, accuracy and consistency.
- Ensure timely submission of safety reports to regulatory authorities.
- Monitor and report on GCP/GVP-related KPIs and quality metrics.
- Support training on GCP, GVP, and compliance topics to internal staff and relevant stakeholders.
- Provide quality and compliance guidance to project teams, clinical staff, and PV teams.
- Support development, implementation and management of inspection readiness strategies.
- Support sponsor and regulatory authority inspections.
- Collaborate with cross-functional teams to embed a quality mindset into day-to-day activities
- Contribute to continuous improvement initiatives to enhance quality culture and compliance maturity.
Qualifications
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- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field required (advanced degree preferred).
- 5+ years of experience in Quality Assurance, Clinical Research, or Pharmacovigilance within the pharmaceutical/biotech industry.
- Strong working knowledge of global GCP/GVP regulations and requirements.
- Experience conducting or managing audits (clinical sites, CROs, vendors, PV systems).
- Prior involvement in health authority inspections preferred.
- Strong analytical, problem-solving, and organizational skills.
- Excellent written and verbal communication skills with ability to interact effectively at all levels.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
- roficiency in Microsoft Office Suite and electronic quality systems.
