Primary Job Function:

The EPD Global Quality Assurance Project Manager contributes to and supports the Abbott EPD’s efforts to create high value therapeutics to address unmet medical needs.

The Quality Assurance Manager role will be responsible for managing GxP related activities associated with the organic and inorganic projects assigned, like License and Acquisition. Product Development and Technology Transfer projects.

Participate in the setting Divisional compliance strategy for both Products in Development and Commercialized Products in alignment with Corporate and Division standards.

Core Job Responsibilities:

• Provide quality oversight of divisional projects assigned ensuring effective and timely execution of project deliverables and smooth transition to the launch of the projects to the commercial phase.

• Liaise and collaborate with key internal and external stakeholders to identify and deliver new product opportunities, divisional driven projects, and compliance initiatives.

• Provide expert knowledge of global regulations and guidance, corporate and division standards on the assigned projects across the EPD worldwide network.

• Support the development, implementation, maintenance and continuous improvement of standardized quality processes and systems.

• Monitor projects operations, proactively identifying potential compliance risk areas and supporting the definition and implementation of appropriate resolution plans.

• Provide support for due diligence audit and external pre-approval inspections to ensure projects execution and regulatory approvals are obtained, with no delays to market entries.

• Ensure the timely execution of defined goals and associated deliverables. Support a learning culture that fosters right first-time quality principles and best practice sharing.

Minimum Education:

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.

• Comprehensive understanding of development and manufacturing of pharmaceutical and non-pharmaceutical products.

• Knowledge of international GxP drug development regulations, including ICH guidelines and ISO standards.

Minimum Experience/Training Required:

• 5+ years pharmaceutical drug development or Quality Assurance or Compliance experience

• Excellent verbal and written communication skills in Business English.

• Flexibility to adapt to changing assignments and ability to effectively prioritize and timely execute defined goals and associated deliverables.

• Troubleshooting and issues resolution skills

• Project Management expertise

• Teamwork attitude

• Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.

• Ability to travel across all geographies.

• Travel amount: no more than 25% / year

Desired: Master’s degree in Chemical, Physical or Biological Sciences, Business Administration (with auditing experience in pharmaceutical or related Industry). Certified Quality Auditor; Registered Qualified Person status is desirable not essential.

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf.

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