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Good Manufacturing Practice - Vendor Support Associate

South San Francisco, CA 94080

Posted: 03/15/2023 Employment Type: Contract Industry: Medical Affairs Job Number: 11130 Pay Rate: $43.00 - $46.00

Job Description


Our client is a leading biotechnology company that discovers, develops, manufactures, and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

Summary:
  • 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 Company requirements.

Duties:
  • 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.
  • 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.

Job Requirements

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.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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