Job Description
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 and is primarily responsible for executing and leading internal and external GMP audits following the company’s auditing policy and guidance to ensure compliance with worldwide regulatory expectations. The position involves ensuring facilities, buildings, equipment, personnel, organization, methods, procedures, records, reports, and controls are in conformance with company requirements and applicable global regulations. By partnering across internal manufacturing facilities, external contract manufacturers and suppliers, the individual will help create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, across the globe. The role also requires negotiating with external firms to attain acceptable corrective actions, independent generation of high‑quality GMP documentation, and extensive communication and partnership with divisional oversight groups and commercial sites.
The minimum annual salary for this position is EUR 82,400 and varies according to the qualifications and experience of the successful candidate.
Responsibilities
* 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 the performance of due diligence, pre‑contract, and Pre‑PAI audits.
* Responsible for accepting audit assignments, performing audit pre‑work, conducting audits, and writing audit reports within defined timeframes.
* Maintain an understanding of company policies, procedures, and guidelines.
* Maintain awareness of evolving industry and regulatory trends and regulations.
* Obtain and maintain auditor qualification through ongoing 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 to maintain the effectiveness and efficiency of the audit program, ensuring it continues to meet site, management, and regulatory expectations.
* Negotiate with external firms to attain acceptable corrective actions and independently generate extensive, high‑quality GMP documentation in partnership with divisional oversight groups and commercial sites.
* Maintain broad expertise of cGMPs, Company Policies, Procedures and Guidelines, regulatory requirements, and other industry standards relevant to pharmaceuticals (including but not limited to 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 audit refusals, generating comprehensive presentations/summary of issues for effective communication to all levels.
* Provide support and administrative functions for the electronic Supplier Tracking and Repository System and assist in data maintenance.
Education Minimum Requirement
* Bachelor’s Degree in Engineering, Biology, Chemistry or related field
Required Experience and Skills
* Minimum of 5‑7 years of manufacturing, technology, and/or quality experience within an FDA, EU, API, Drug Product, Medical Device or equivalent environment.
* Subject‑matter expertise, including knowledge and demonstrated application in 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 the 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, able to adapt in a dynamic environment.
* Ability to travel globally approximately 25% of the time.
Preferred Experience and Skills
* Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
* Demonstrated ability to lead and drive results/impact for critical business/compliance initiatives.
* Experience in process improvement and implementation of simple, compliant systems across diverse areas.
* Knowledge and expertise in application of Quality Risk Management pertaining to auditing.
* Lean Six‑Sigma belt or demonstrated process improvement experience.
* External engagement in regulatory or industry forums.
* Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.
Location
* Can be based at EU or US Animal Health sites.
* For Austria
Travel Requirements: Approximately 25% worldwide travel.
Hybrid Work Model: Effective September 5 2023, employees in office‑based positions in the U.S. will work a hybrid model comprising three total days on‑site per week, Monday‑Thursday, with Friday designated as a remote‑working day, unless business‑critical tasks require an on‑site presence. This model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions, positions covered by a collective‑bargaining agreement, or any positions where remote work cannot reasonably meet job requirements.
Employee Status
Regular
Relocation
No relocation
Visa Sponsorship
No
Shift
Not indicated
Valid Driving License
No
Hazardous Materials
N/A
Job Posting End Date
03/17/2026 (The posting is effective until 11 59 59 PM on the day before the listed end date.)
Requisition ID
R370454
EEO Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights, EEOC GINA Supplement, and learn more about your rights, including under California, Colorado and other US State Acts.
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