Group Lead Expert (m/f/d) - Good Distribution Practice

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

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

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Job ID: 64168

Location: Wien, AT Springe, DE Stockholm, SE Lingolsheim, FR

Job Level: Professionals

Job Category: Quality

Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

As a Group Lead Expert – Good Distribution Practice (GDP), you will play a key role in ensuring GDP compliance across Octapharma's global operations. You will drive the qualification and oversight of distributors, strengthen quality standards throughout the distribution network and collaborate with international stakeholders to ensure the safe and compliant distribution of our life-saving medicines.

The position will be filled in Vienna (Austria), Springe (Germany), Stockholm (Sweden) or Lingolsheim (France).

Join us in shaping our vision of providing new health solutions advancing human life.

Your main tasks and 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

Your expertise and ideal skill set

• University degree in Pharmacy, Chemistry, Chemical Engineering or a 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 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

You will thrive in this role if you enjoy taking ownership, translating regulatory requirements into practical solutions and collaborating across international teams to ensure the safe and compliant distribution of life-saving medicines.

Your department - where you make an impact

• We, the Group Quality department, are responsible for the development of policies and procedures for all GQ Plasma activities based on current applicable regulations to ensure a standardized approach throughout the organization.
• We are divided into GQ Plasma, GQ Control, Group Quality Assurance, Group Stability Studies, Group QC Method Validation, Group QC Incoming Goods and Group Quality & Compliance Projects.

Thrive with us

• You help save lives - Every day is meaningful as we produce life-saving medicines
• Family values - Long-term perspective for employees and relationships
• Be rewarded with an attractive salary and benefits package
• You will have a high level of influence where you can make a difference and leave your footprint
• Work with skilled and fun colleagues in a relatively informal organization
• Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions

Additional information (Austria only):

The minimum gross salary according to the collective agreement (chemical industry) is EUR 4,355.55 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.

It´s in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.

Do you have any questions? Then get in touch with your contact person.

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 200 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.