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Sr. Manager of Supplier Quality Assurance - Remote

Posted 6 weeks ago
QA
Full Time
GA, USA

Overview

The Sr. Manager of Supplier Quality Assurance will be responsible for evaluating or facilitating supplier performance evaluation and managing the GxP Audit Program. The candidate will be the primary contact for scheduling routine and qualification audits.

In Short

  • Lead Vendor Audit Program
  • Manage execution of outsourced audits
  • Execute internal audits
  • Support the vendor approval process
  • Ensure supplier performance meets expectations
  • Monitor supplier audit response and CAPAs
  • Create and report supplier performance data
  • Assist with the development of SOPs
  • Travel Approx 20% + of the time

Requirements

  • BS in a science-related field
  • 5+ years of experience in Quality Assurance
  • 3-5 years of Supplier/Vendor management experience
  • ASQ/SQA/ISO Certified Quality Auditor
  • Experience in supplier quality and audits
  • Strong written and verbal communication skills
  • Excellent interpersonal and networking skills
  • Experience with FDA GMP, GCP, GVP regulations
  • Demonstrated strong organizational skills

Benefits

  • Equal Opportunity Employer
  • Culturally diverse workforce
  • Consideration for employment without regard to personal characteristics
Catalyst Pharmaceuticals logo

Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is a biopharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare diseases, particularly in the neurology and oncology sectors. The company focuses on advancing the adoption of its lead product, FIRDAPSE, for Lambert Eaton Myasthenic Syndrome (LEMS) in oncology settings, especially for small cell lung cancer (SCLC) patients. Catalyst is committed to strategic marketing initiatives that enhance awareness and engagement, while fostering collaboration across various functions including sales, medical affairs, and market research. With a strong emphasis on compliance and stakeholder engagement, Catalyst Pharmaceuticals aims to improve patient outcomes through effective communication and strategic brand positioning.

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