Good Manufacturing Practice (GMP) Vendor Support Associate

Software Guidance & Assistance, Inc., (SGA), is searching for a Good Manufacturing Practice (GMP) Vendor Support Associate for a CONTRACT assignment with one of our premier Pharmaceutical Services clients in South San Francisco, CA. Responsibilities :

• Responsible for supporting the strategic oversight plan for ensuring GMP(Good Manufacturing Practice) vendor compliance in accordance with Pharmacovigilance (PV) Vendor PV compliance per health authority and global requirements.
• 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.

Required Skills:

• 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

SGA is a Certified Women's Business Enterprise (WBE) celebrating over thirty years of service to our national client base for both permanent placement and consulting opportunities. For consulting positions, we offer a variety of benefit options including but not limited to health & dental insurance, paid vacation, timely payment via direct deposit. SGA accepts transfers of H1 sponsorship for most contracting roles. We are unable to sponsor for Right-to-Hire, Fulltime, or Government roles. All parties authorized to work in the US are encouraged to apply for all roles. Only those authorized to work for government entities will be considered for government roles. Please inquire about our referral program if you would like to submit a candidate for any of our open or future job opportunities. SGA is an EEO employer. We encourage Veterans to apply. To view all of our available job postings and/or to learn more about SGA please visit us online at www.sgainc.com .