Global QA Lead — Pharmaceutical Quality Systems

Octapharma Sweden; Stockholms län; On-site; SEK 1,962,000 - 2,447,000; Full time

Job summary

Octapharma Sweden is seeking a senior QA leader to advance GMP compliance and harmonise global quality systems across sites. You will drive deviation management, CAPA programs and change control while coordinating cross-site QA initiatives and audits.

Travel within Europe is expected as part of the role. The ideal candidate has 10+ years in pharmaceutical QA, strong stakeholder skills, and a background in GMP operations across Europe and the US.

Qualifications

• 10+ years QA experience in pharmaceutical manufacturing.
• Experience overseeing GMP quality systems and cross-site quality initiatives.
• Strong stakeholder management and collaboration across sites.
• Willingness to travel 5-10 times per year, mainly in Europe.
• Audit experience is desirable but not required.

Responsibilities

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

Skills

GMP compliance

Quality systems

Deviations & CAPA

Change control

Investigations

Cross-site leadership

Stakeholder management

Travel Europe

Education

University degree in Chemistry, Chemical Engineering, Pharmacy, or comparable field

Job description

Octapharma Sweden is seeking a senior QA leader to advance GMP compliance and harmonise global quality systems across sites. You will drive deviation management, CAPA programs and change control while coordinating cross-site QA initiatives and audits.

Travel within Europe is expected as part of the role. The ideal candidate has 10+ years in pharmaceutical QA, strong stakeholder skills, and a background in GMP operations across Europe and the US.