Associate Director, Animal Health, Global Quality Technical and Compliance Team

We have an exciting opportunity for an Associate Director, Animal Health, Global Quality Technical and Compliance Team.
*** This role can be based at EU or US Animal Health sites***

The position is primarily responsible for executing and leading internal and external GMP audits following company auditing policy and guidance to ensure compliance with worldwide regulatory expectations. This includes ensuring that facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with company requirements and applicable global regulations. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality GMP documentation as well as extensive communication and partnership with divisional oversight groups and commercial sites.

• The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of animal health sites, contractors, business partners, and suppliers. This requires approximately 25% worldwide travel.
• Support new business opportunities through due diligence, pre-contract, and pre-PAI audits.
• Accept audit assignments, perform audit pre-work, conduct audits, and write audit reports within defined time frames.
• Maintain an understanding of company policies, procedures, and guidelines.
• Maintain awareness of evolving industry and regulatory trends/regulations.
• Obtain and maintain auditor qualification through ongoing training and continuing education programs.
• 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 ensure it continues to meet site, management, and regulatory expectations.
• Maintain broad expertise of cGMPs, company policies, procedures and guidelines, regulatory requirements, etc. relevant to the pharmaceutical industry including biologics, medical devices, vaccines, small molecules, combination products, APIs and controlled substances.
• Lead & coordinate with Procurement and impacted Site Quality leads on critical audit findings and/or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed.
• Provide support and administrative functions for the electronic Supplier Tracking and Repository System, and assist in data maintenance.
• Bachelor’s Degree in Engineering, Biology, Chemistry or related field.

• Minimum 5–7 years of manufacturing, technology, and/or quality experience within FDA/EU, API, Drug Product, Medical Device or equivalent environment.
• Subject Matter Expertise within one or more of the following areas:
  Medical Device/Combination products, Biologics, Vaccines, APIs, Non-sterile Drug Products, or Sterile Drug Product manufacturing;
  Biologics auditing experience is required.
• Thorough understanding of Quality Management Systems and processes to support manufacturing of drug substances, drug 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).
• Detail oriented and organized.
• Positive change agent capable of adapting in a dynamic environment.
• Ability to travel globally approximately 25% of the time.

• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
• Demonstrated ability to lead and drive results/impact for critical business/compliance initiatives.
• Demonstrated ability for process…