FDA Readiness & GMP Compliance Expert (Veterinary Pharmaceuticals)

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.

Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleague globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

The Opportunity 

We are seeking an experienced FDA Readiness and GMP Compliance Consultant to support the implementation of FDA regulatory requirements at a veterinary pharmaceutical manufacturing site. The consultant will play a key role in assessing current compliance status, identifying gaps, developing remediation plans, and preparing the site for successful FDA inspections.

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

• Leading and supporting FDA readiness activities across manufacturing, quality, laboratory, engineering, and supply chain functions.
• Assessing Quality Management Systems (QMS) against FDA requirements, current Good Manufacturing Practice (cGMP), and regulations applicable to veterinary medicinal products.
• Conducting gap assessments and developing site-specific remediation and compliance improvement plans.
• Supporting the development, review, and implementation of procedures, quality systems, and documentation required for FDA compliance.
• Preparing the site for FDA inspections through mock inspections, audit simulations, and inspection readiness programs.
• Training and coaching cross-functional teams on FDA expectations, inspection behaviour, data integrity, quality culture, and GMP compliance.
• Supporting risk assessments, CAPA implementation, deviation management, change control, validation, and data integrity initiatives.
• Providing expert guidance during inspection preparation, inspection execution, and post-inspection remediation activities.
• Collaborating with site leadership to establish and maintain a sustainable inspection-ready culture.

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, or a related scientific discipline.
• Minimum 10 years of experience in GMP-regulated pharmaceutical or veterinary pharmaceutical manufacturing environments.
• Strong knowledge of FDA regulations, cGMP requirements, Quality Systems, and Data Integrity principles.
• Demonstrated experience supporting or leading FDA inspection readiness programs.
• Direct participation in FDA inspections, including pre-inspection preparation, inspection management, and response activities.
• Proven track record of successfully preparing manufacturing sites for FDA inspections and regulatory audits.
• Experience performing GMP gap assessments and implementing remediation programs.
• Strong understanding of manufacturing operations, quality assurance, quality control laboratories, validation, and regulatory compliance.
• Experience within veterinary pharmaceuticals, animal health products, or related regulated industries is highly desirable.
• Excellent communication, stakeholder management, and training skills.
• Ability to work effectively with senior leadership and cross-functional teams.
• Previous experience serving as a Quality Assurance leader, Compliance Manager or FDA Readiness Consultant.
• Experience with successful FDA inspections resulting in no major observations or successful remediation of regulatory findings.
• Familiarity with EU GMP requirements and experience harmonizing EU and FDA regulatory expectations.
• Experience supporting greenfield projects, site start-up activities, or regulatory approval readiness programs.
• Knowledge of Croatian language.
  
  

Key competencies we're looking for are:

• FDA Inspection Readiness
• GMP Compliance
• Quality Systems Management
• Data Integrity
• CAPA Management
• Risk Management
• Audit and Inspection Leadership
• Training and Coaching
• Continuous Improvement

All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at recruituk@dechra.com

The legal employer on behalf of Dechra in Croatia is Genera Inc.  

Genera Inc. is a part of the Dechra Group since 2015