GDP Group Lead Expert – Quality & Compliance (Global)

Octapharma-Plasma

Wien

On-site

EUR 44,000 - 53,000

Full time

2 days ago
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Benefits offered by this job

Salary and benefits package

Job summary

Octapharma-Plasma is seeking a Group Lead Expert – GDP to ensure GDP compliance across our global distribution network and drive distributor qualification, audits and quality initiatives. The role collaborates with international teams to ensure safe, compliant distribution of life-saving medicines.

You will oversee GDP training, auditing, and quality documentation, with responsibilities spanning multiple sites and regulatory contexts. Vienna-based with flexibility to other sites.

Qualifications

  • University degree in Pharmacy, Chemistry, Chemical Engineering or related scientific discipline.
  • At least 5 years of 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 requirements for combination products (CFR Parts 3 and 4, EU MDR Annex 1)
  • Strong project management skills and experience driving initiatives across multiple sites
  • Excellent communication and stakeholder management skills in an international environment

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
Auditing
Project management
Communication
Stakeholder management
Cross-site coordination

Education

University degree in Pharmacy, Chemistry, Chemical Engineering or related

Job description

Octapharma-Plasma is seeking a Group Lead Expert – GDP to ensure GDP compliance across our global distribution network and drive distributor qualification, audits and quality initiatives. The role collaborates with international teams to ensure safe, compliant distribution of life-saving medicines.

You will oversee GDP training, auditing, and quality documentation, with responsibilities spanning multiple sites and regulatory contexts. Vienna-based with flexibility to other sites.

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