Consulting Opportunity: Associate Director Validation, Site Quality – AstraZeneca

Are you an experienced validation and quality expert looking for a consulting assignment within a global pharmaceutical company? We are seeking an Associate Director Validation for a consulting role at AstraZeneca in Gothenburg. This assignment offers the opportunity to play a key role in maintaining GMP compliance and ensuring the License to Operate at AstraZeneca’s development site.

As an Associate Director, you will develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to your area. You will mentor and support junior colleagues, build strong customer relationships, and participate in GxP audits/initiatives. You will also be responsible for developing and approving GMP documentation and QA risk assessments, providing Quality input into business improvement projects, and be part of external Regulatory Authority GMP inspections. You will work closely with the leadership teams of their customers to set strategic direction for quality within that area, maintaining quality oversight and driving continuous improvement.

Responsibilities

• Provide quality oversight and compliance support for validation activities.
• Act as a subject matter expert in validation, ensuring alignment with AstraZeneca and regulatory requirements.
• Develop and approve GMP documentation and validation protocols.
• Lead quality risk assessments and process improvement projects.
• Participate in Regulatory Authority GMP inspections and internal audits.
• Collaborate with stakeholders and provide strategic quality direction.

Qualifications

• 5–10 years of experience in validation within a GMP-regulated pharmaceutical environment.
• Strong knowledge of quality systems, validation standards, and regulatory compliance.
• Experience in equipment, automation, and IT system validation.
• Proven ability to lead projects, solve complex problems, and make strategic quality decisions.
• Excellent communication and stakeholder management skills.

Why Take on This Assignment?

This consulting role at AstraZeneca offers a unique opportunity to collaborate with experts in pharmaceutical quality and validation. AstraZeneca’s Gothenburg site is one of the company’s key R&D hubs, providing an inspiring and innovative workplace.

Start: April
Duration: 12 months 
Location: Gothenburg

Is this you? Don’t hesitate to apply today – we are conducting interviews on an ongoing basis.

We look forward to receiving your application!