GDP Group Lead - Quality & Distribution Compliance

Octapharma; Wien; On-site; EUR 176,000 - 220,000; Full time

Benefits offered by this job

Salary and benefits package

Internal trainings

International environment

Job summary

Octapharma is seeking a Group Lead Expert – GDP to ensure GDP compliance across its global distribution network and to oversee distributor qualification, audits, and quality agreements at multiple sites.

The role involves driving quality initiatives, overseeing transportation processes, and collaborating with international stakeholders to maintain safe and compliant distribution of life-saving medicines, with postings in Vienna, Springe, Stockholm, or Lingolsheim.

Qualifications

• University degree in Pharmacy, Chemistry, Chemical Engineering or related scientific discipline.
• At least 5 years of experience in GDP and pharmaceutical quality activities.
• At least 3 years of GDP auditing experience and documented lead auditor training.
• In-depth knowledge of GDP regulations, including CFR Parts 3 and 4, EU MDR Annex 1.

Responsibilities

• Ensure GDP compliance across Octapharma's global distribution network.
• Manage the qualification and oversight of distributors and subsidiaries, including audits and quality agreements.
• Drive quality initiatives and continuous improvement across the organisation.
• Oversee transportation processes, approve validation activities and collaborate with local GDP Officers.
• Monitor regulatory developments and translate requirements into corporate standards and procedures.
• Lead the corporate GDP Forum to promote knowledge sharing and alignment across sites.
• Represent Group Quality Assurance in cross-functional supply chain projects and support the harmonisation of the Pharmaceutical Quality System.
• Develop and deliver training and review and approve corporate quality documentation.

Skills

GDP compliance

GDP auditing

Quality systems

Regulatory knowledge

Project management

Stakeholder mgmt

Cross-site collaboration

Education

University degree in Pharmacy, Chemistry, Chemical Engineering or related

Job description

Octapharma is seeking a Group Lead Expert – GDP to ensure GDP compliance across its global distribution network and to oversee distributor qualification, audits, and quality agreements at multiple sites.

The role involves driving quality initiatives, overseeing transportation processes, and collaborating with international stakeholders to maintain safe and compliant distribution of life-saving medicines, with postings in Vienna, Springe, Stockholm, or Lingolsheim.