GMP Vendor Support Associate
1 DNA Way South San Francisco, CA 94080 US
Summary of position
Based on identified risks and process gaps, the Good Manufacturing Practice (GMP) Vendor Support Associate is responsible for supporting the strategic oversight plan for ensuring GMP vendor compliance in accordance with Pharmacovigilance (PV) Vendor PV compliance per health authority and global organizational requirements.
- Helps determine priorities and resource load balancing to manage backlogs, action items, and business as usual with the oversight of:
- IT Issue Management
- Supports the GMP Vendor Strategy Lead on operations performed, including the implementation of policies/procedures and ensuring quality and GMP/PV requirements are met in accordance with contractual obligations.
- Training coordination and oversight
- Action and oversee onboarding and revocation of access
- Participates in and supports GMP PV Vendor and oversight activities such as assisting in the development of the agenda for PV vendor and internal oversight meetings, create meeting presentations, collate and visualize data (track status for critical milestones and metrics), communications (agenda, reminders, pre-reads) prior to oversight meetings, as applicable, responsible for meeting minutes, appropriate documentation, and archival, creation of action items and follow-ups on action items.
- US Complaints Management:
- Management of product complaint intake and quality record processing per Quality global/local SOPs.
- Initiation and reconciliation of Medical Product Complaints (MPCs), Technical Product Complaints with Special Situations, and Post Marketing Reportable Events (PMSRs) per global/local SOPs with local safety unit (LSU).
- Support US Call Center training, documentation, QC and issue resolution.
- Prepares and represents US Affiliate in audits as an expert in job discipline.
Education, Experience, and Other Requirements:
- Life sciences degree BSc required or 2+ years in PV/GMP pharmacovigilance or compliance-related role
- Knowledge of FDA GMP safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
- Analytic and computer skills (e.g., Microsoft Excel, other data visualization tools) (Required)
- Experience overseeing quality PV/GMP systems and creating/utilizing AI solutions
- Flexibility to accommodate differences in global time zones
- Able to travel as per business needs required
- Able to be agile and adapt to shifting priorities and needs
Pay Rate Range: $35-45/hr. Salary will be commensurate with experience
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