Group Quality Lead – GMP/PQS Across Sites

Octapharma; Wien; On-site; EUR 44,000 - 53,000; Full time

Job summary

Octapharma Vienna is seeking a Group Subject Matter Expert for GMP regulations to advise sites, monitor regulatory changes, and drive a harmonised Pharmaceutical Quality System. You will lead QA initiatives across Europe and the US, coordinate audits, and support local QA teams while traveling 5–10 times per year.

The role requires a university degree in a scientific field and 10+ years of QA experience in pharmaceutical manufacturing with strong GMP expertise.

Qualifications

• University degree in a relevant scientific field.
• 10+ years of QA experience in pharmaceutical manufacturing.
• Experience overseeing GMP quality systems across Europe and the US.
• Proven experience leading cross-site quality initiatives.
• Willingness to travel 5–10 times per year within Europe.

Responsibilities

• Act as Group Subject Matter Expert for GMP regulations and guidelines, advising Octapharma sites on GMP topics.
• Monitor evolving GMP regulations and communicate changes through Quality Bulletins.
• Lead the development and harmonisation of the Pharmaceutical Quality System, including global procedures and templates.
• Participate in and support intersite audits of manufacturing and packaging sites.
• Coordinate Group Quality activities, including mock recall and alignment with local QA teams.

Skills

GMP regulations

Quality management

Cross-site coordination

CAPA & deviations

Auditing awareness

Stakeholder management

Education

University degree in Chemistry, Chemical Engineering, Pharmacy

Job description

Octapharma Vienna is seeking a Group Subject Matter Expert for GMP regulations to advise sites, monitor regulatory changes, and drive a harmonised Pharmaceutical Quality System. You will lead QA initiatives across Europe and the US, coordinate audits, and support local QA teams while traveling 5–10 times per year.

The role requires a university degree in a scientific field and 10+ years of QA experience in pharmaceutical manufacturing with strong GMP expertise.