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Sr. Specialist/Manager, GMP, Global QA

Company: Ascent Services Group
Location: San Mateo
Posted on: January 9, 2022

Job Description:

Sr. Specialist/Manager, GMP, Global QA
San Mateo, CA
Position Summary:
This position is hands on role within Global QA organization. This individual will be working closely with internal functional groups and external partners and/or contract manufacturing to support Global market expansion and ROW. Support country specific requirements and regional launches and ROW filing. Escalate compliance issues to senior management in a timely manner. This role requires strong planning, organizing and prioritizing skills to meet filing timelines.

Essential Functions of the Job:

  • Collaborate with internal cross functional groups including QA Operations team to provide cGMP documents and ensure compliance with filing timelines
  • Manage cGMP Quality documents collected from CMOs related to market expansion
  • Provide Quality support to drive data and deliver on time for filing
  • Monitor the target dates, prioritize, collate, and maintain updated documents per country specific requirements
  • Communicate regularly all pertinent information to the respective Global and Regional Regulatory Affair (RA).
  • Respond quickly and efficiently to support regulatory filings and inspection as needed
  • Discuss technical product questions with internal GQA teams and escalate issues that require strategic mitigation
  • Participate in all relevant global expansion meetings and huddles
  • Liaise with Regulatory and business partners to understand document needs for filing and health authority's response to questions
  • Steer specialized in-country requirements such as good distribution practice, good importation practice, and testing needs
  • Interface within GQA to ensure compliance-related activities including audits and quality agreements are initiated/completed on time.
  • Serve as primary regional point of contact for partnership products, region to be assigned
  • Organize QA Sharepoint folders with request lists from Regulatory and documents submitted from contract sites
  • Monitor updates to site master file, inspection list, GMP certificates for expiry, etc. in internal dashboard tracking tool
  • Collaborate with regulatory teams to collate filing acceptance clearance for each country
  • Other duties as assignedQualifications:
    • Minimum of 8-10 years pharmaceutical or biotechnology industry GMP experience with at least 5 years of experience in quality assurance
    • In-depth knowledge of GMPs (EU, US, CN, AU, JP)
    • Experience in working with external partners and/or contract manufacturing
    • In-depth knowledge of Quality principles, concepts, industry practices and standards
    • Motivation to work independently with scientific/technical personnel
    • Ability to showcase QA knowledge and apply critical thinking skills
    • Strong project management skills
      Education Required: Bachelor of Science degree, in a related scientific discipline
      Computer Skills: Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
      Travel for Work: As Required
      Job Type: Direct Placement
      Location: San Mateo, CA
      Job ID: 21-07265
      Date Updated: July 13, 2021 Summer Martinez is recruiting for this position. Corporate Office
      1001 Galaxy Way, Suite 405
      Concord, CA 94520
      925-627-4900
      info@ascentsg.com Employment Verifications
      Via The Work Number, employer code 105779 Additional office locations in Chico, CA; Chicago, IL; Los Angeles, CA.

Keywords: Ascent Services Group, San Mateo , Sr. Specialist/Manager, GMP, Global QA, Executive , San Mateo, California

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