Specialist Ii, Quality Assurance

Emergent Biosolutions Inc

Dublin, Ireland
On-site
Quality systems and compliance
Combination product(s) (devices)
Good manufacturing practice (gmp)
Reporting to the Senior Manager, Product Quality, this is a senior position requiring significant expertise/specialization in QA area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices)

Job Summary

  • Reporting to the Senior Manager, Product Quality, this is a senior position requiring significant expertise/specialization in QA area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices).
  • The role is responsible for QA lead for internal and external projects, independent oversight of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements, executing Quality Management System requirements, and ensuring the realization of industry best practices for GxP.
  • As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own.

Matching Summary

Reporting to the Senior Manager, Product Quality, this is a senior position requiring significant expertise/specialization in QA area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices).

Skills & Requirements

Must-have

  • Quality Systems and Compliance
  • Combination Product(s) (Devices)
  • Good Manufacturing Practice (GMP)
  • Quality Management System
  • GxP industry best practices
  • Deviation, Change Control, CAPA, Complaints

Nice-to-have

  • Independent oversight of commercial manufacture
  • Quality approval proxy
  • Continuous improvement projects
  • Mature leadership and interpersonal influencing skills
  • Operate efficiently in a complex matrix organization

Key Requirements

  • Bachelors of Science in Pharmacy, Chemistry, Microbiology or related field
  • Minimum 8 years of cGMP experience
  • 2-3 years in a senior or leadership Quality Assurance role
  • Broad experience and thorough understanding of international GMP Quality Management System regulations
  • Demonstrated experience owning, driving and leading Quality initiatives

Work Rights

Not specified

Tailored Resume

Cover Letter