Quality Assurance Operations Manager

Quality Assurance Operations Manager

Job Introduction

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

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

We are look for a Quality Assurance Operational Manager for Dechra Pharmaceuticals Manufacturing at our Fort Worth, TX facility to promote, develop and oversee compliance of the company quality system. Effectively assuring compliance of customer requirements by managing quality policies, standards, procedures, programs and practices while driving and facilitating continuous improvement .

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

• To oversee quality and ensure a strong factory floor presence within the Manufacturing and Packaging areas
• To manage the CAPAs, Deviations, Audits and Vendor Quality Management Programs
• To promote quality culture across the site by liaising with cross functional teams
• To develop and manage the QA team and provide coaching and mentoring on Quality Management Systems
• To participate in internal and external audits, and support vendor quality management activities
• To conduct compliance risk assessments, trend analysis and provide recommendations for compliant business activities
• To focus on continuous improvement of processes. Update procedures and policies as needed to maintain compliance and improvement
• To establish, track and present Quality Metrics to support Quality Management Review
• To provide guidance for higher level decisions required for change management and deviation investigations
• To provide support and participate in internal and external, and other regulatory agency inspections (MHRA, FDA, EMA, etc.)
• To assist the QA with the planning of required internal annual audits and other audits as needed and assigned
• To conduct training and coaching of the QA team members on the how to conduct audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks as well as review/evaluate adequate completion of all planned actions via supporting documentation
• To supply feedback to the Head of Quality and SLT on any trends and serious quality issues or non-compliances that are detected by QA staff whilst carrying out duties for GMP and GDP activities
• To liaise with auditors to ensure that the CAPAs resulting from audits associated with the assigned programmes and studies are allocated a CAPA owner and closed out appropriately and in a timely manner
• To author, review and/or authorise Standard Operating Procedures (SOPs)
• To ensure adequate QA resources are available to deliver the agreed business targets
• To proactively influence management regarding the adoption of standards to improve quality, efficiency and compliance within Dechra

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:

• Minimum of 3 years of experience in pharmaceutical industry with management experience
• Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience of auditing/inspection techniques, including internal process/system and documentation audits, as well as experience of related quality assurance principles applicable to pharmaceutical manufacturing
• Competency in management and tracking of Quality Metrics- CCs, CAPAs, Deviations, Complaints, PQRs, audits and audit reports
• Previous people leadership experience preferred
• Previous experience working with MHRA, 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 organisational skills
• Ability to prioritise, demonstrating good time management skills
• Self-motivated, with the ability to work proactively using own initiative

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 other incentives 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 .