Senior Manager, GVP Operational Quality
Remote, EST Hours
Schedule:
Part-Time (Approximately 20 hours/week)
Duration:
6-Month Contract (Potential for Extension)
Pay:$88-93/ph
In this role, you will support operational quality initiatives within the pharmacovigilance domain, focusing on data analysis, compliance oversight, and continuous improvement. You will collaborate with cross-functional teams to ensure high standards in global pharmacovigilance (GVP) practices and maintain an inspection-ready quality environment.
Key Responsibilities:
- Support day-to-day operations of the GVP Quality Management System (QMS), ensuring alignment with regulatory and corporate expectations.
- Collect, analyze, and interpret Quality data to support metrics reporting and continuous improvement initiatives.
- Prepare materials and insights for the Quality Leadership Team (QLT) and other key stakeholders.
- Conduct quality control (QC) of GVP metrics reports prior to distribution.
- Contribute to and oversee updates to relevant sections of the Pharmacovigilance System Master File (PSMF).
- Partner with internal stakeholders to ensure compliant and consistent safety vigilance practices.
- Provide consultative guidance on GVP-related business initiatives and quality system improvements.
- Conduct periodic process checks to maintain ongoing inspection readiness.
Essential Skills and Qualifications:
- Bachelor’s degree in life sciences, computer science, economics, or a related quantitative field.
- 6–8 years of experience in the biopharmaceutical/pharmaceutical industry, with a strong focus on pharmacovigilance and quality systems.
- Hands-on experience leading projects and managing cross-functional initiatives.
- Working knowledge of GxPs and GVP requirements.
- Strong problem-solving abilities and passion for continuous improvement.
- Excellent written and verbal communication skills, with the ability to engage stakeholders across departments.
- Proficient in Microsoft Office Suite (Outlook, Excel, Word, etc.).
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