Global Auditing Associate Director

Job Description

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. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The successful candidate can be based anywhere in Europe.

Position Responsibilities:

• The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of human health sites, animal health sites, contractors, business partners, and suppliers.
• Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits.
• Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes.
• Maintain an understanding our company policies, procedures, and guidelines.
• Maintain awareness of evolving industry and regulatory trends/regulations.
• Obtain and maintaining auditor qualification through on-going training and continuing education programs to enable the performance of successful audits
• Coordinate with Site Quality leads on audit refusals and postponements.
• Lead project initiatives, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet site, management, and regulatory expectations

Education Minimum Requirement:

• Bachelor’s Degree in Science, Chemistry, (Micro-) Biology, Engineering (or equivalent).

Required Experience and Skills:

• Extensive experience performing audits and/or quality operations experience.
• Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination products, Biologics, Vaccines, API’s, Non-sterile Drug Products, or Sterile Drug Product manufacturing. Biologics auditing experience is required.
• Thorough understanding of Quality Management Systems and process to support the manufacturing of drug substances, drugs products, and medical devices.
• 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.
• Excellent communication, negotiation, influencing, and strategic thinking skills.
• Review and approve audit reports (as assigned).
• Must be detail oriented and organized.
• Must be a positive change agent and able to adapt in a dynamic environment.
• Must have the ability to travel approximately 50% of the time.

Preferred Experience and Skills:

• Extensive experience auditing biologics and vaccine manufacturing sites.
• External engagement in regulatory or industry forums.
• Prior experience at a health authority performing GMP inspections.
• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
• Demonstrated ability to lead and drive results for business initiatives.
• Demonstrated ability for process improvement.
• Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/processes, or technical areas.
• Experience with development, implementation ,and optimization of IT tools to deliver business outcomes.