Job Introduction

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

Dechra is 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 colleagues 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 

Reporting to the Head of Quality, the Operational Quality Manager shall enhance practices and promote a culture which is consistent with cGMP while effectively assuring compliance of customer requirements by managing quality policies, standards, procedures, programs and practices while driving and facilitating continuous improvement. The Operational Quality Manager supervises the quality assurance staff, both QA Associates and a QA Batch Record Release Associate. This role will manage Quality Assurance activities and GMP compliance during production.

Role Responsibility

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

• Manage, plan, and direct the Operational Quality team, ensuring a strong factory floor presence within the Manufacturing, Packaging and warehousing areas
• Conduct investigations for Deviations (Planned/Un-Planned), Nonconforming Material Reports, Supplier Corrective Action Reports, related to production processes to manufactured product by Dechra Fort Worth.
• Participate in the investigation for Customer Complaints related to production processes.
• Provide feedback to the Head of Quality and the Site Leadership Team on any trends and serious quality issues or noncompliance’s that are detected through investigations
• Manage the inspection and release process of materials and components
• Manage the Batch Production Record from issuance of batch records to operations to release of finished product.
• To promote quality culture across the site by liaising with cross functional teams and provide coaching and mentoring on Quality Assurance
• Conduct Risk Assessments in production processes and provide recommendations for compliance
• Conduct investigations of undesirable trends in production processes performance and unplanned events, perform root cause analysis, and develop and implement corrective or preventive actions
• To participate in internal and external audits and regulatory agency inspections (FDA)
• To focus on continuous improvement of processes. Update procedures and policies as needed to maintain compliance and improvement
• To author, review and/or authorize Standard Operating Procedures related to operational activities
• Act as a backup for Head of Quality

Key Performance Indicators

• Deliver batch release as per agreed targets
• Support technical and quality assurance related projects
• Support in hosting internal and externals audits

The Ideal Candidate

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

Qualifications

• Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
• A formal qualification in quality assurance/quality management in regulated pharmaceutical environment

Knowledge and Experience
• Minimum of 5 years of experience in pharmaceutical industry with 2 years management experience
• Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience of auditing/inspection techniques, including process/system and documentation audits, as well as experience of quality assurance principles applicable to pharmaceutical manufacturing
• Knowledgeable in quality management systems including Change Controls, CAPAs, Deviations, Complaints, and audit reports
• Previous people leadership experience preferred
• Previous experience working with FDA and participating in regulatory agency inspections
• Previous experience of project management, time management and people management

Skills
• Demonstrates a “can do” approach
• Must have Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and work effectively in a multi-disciplinary team
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment
• Ability to multi-task, set priorities and meet strict deadlines
• Demonstrates time management skills
• Using logic and reasoning to identify solutions to problems
• Ability to lead, motivate, coach, and teach others
• First class organizational skills
• Ability to prioritize, demonstrating good time management skills
• Self-motivated, with the ability to work proactively using own initiative

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an employee stock purchase plan for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.

Dechra Pharmaceuticals PLC