Senior Specialist Global Auditing- Anywhere in Europe

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Our Global Audit team partners across our internal manufacturing facilities, external contract manufacturers and suppliers to create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We have an exciting opportunity for a Senior Specialist Global Auditing to be based anywhere in Europe.

Position Responsibilities:

• Conduct audits of internal sites, contractors, and suppliers within the EU/ME region.
• Perform audit pre-work, conduct audits, and ensure post-audit activities are completed within defined timeframes.
• Partner and communicate with divisional oversight groups and commercial sites to prepare for audits.
• Maintain a broad-based expertise of cGMP's, our Company Policies, Procedures and Guidelines, regulatory requirements.
• Obtain and maintain certification on various technical and quality auditing topics.
• Maintain awareness of evolving industry and regulatory trends/regulations.
• Support new business opportunities through Due Diligence and Pre-Contract Audits.
• Coordinate with Procurement and impacted Site Quality leads on critical audit findings and/or audit refusals.
• Lead initiatives and drive results on assigned projects to improve effectiveness and efficiency of the audit program, ensuring it continues to meet site, management, and regulatory expectations.

Qualifications, Skills & Experience Required:

• Education Minimum Requirement: Bachelor's Degree in Science.
• Auditing experience within the pharmaceutical industry.
• Experience performing audits of external and internal manufacturers and testing laboratories.
• Thorough understanding of Quality Management Systems.
• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
• Ability to work independently with limited supervision in a virtual-management environment.
• High technical expertise in one or more of the following areas: non-sterile drug products, sterile drug products, medical devices, biologics, or vaccine manufacturing.
• Excellent communication and influencing skills.
• Ability to travel domestically and globally approximately 50% of the time.

Preferred Experience and Skills:

• Experience in auditing biologics, vaccine, and medical devices manufacturing sites.
• ASQ or IRCA Lead Auditor certification.
• External engagement in regulatory or industry forums.
• Lean six-sigma belt or process improvement experience.

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life.