Compliance Manager

Compliance Manager

Who are Dechra?

Dechra is an international specialist veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture and sales and marketing of high quality products exclusively for veterinarians worldwide.   

With offices across 24 countries in Europe and North America, we export to over 50 countries worldwide and have six manufacturing sites. 

Where is the role based?

Skipton, North Yorkshire

The Dechra group employ over one thousand people. Revenue in 2018 reached £407.1m

Job Purpose

Maintain and improve the Quality Systems within Dechra Pharmaceuticals Manufacturing Skipton. Promote, develop and oversee compliance of company quality system. Effectively assuring compliance of customer requirements by managing quality policies, standards, procedures, programs and practices while driving and facilitating continuous improvement.

Accountabilities

•  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 Compliance 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 audits
• To host and manage external audits including regulatory agency inspections (MHRA, FDA, EMA, etc.)
• To manage and plan required internal annual audits and other audits as needed and assigned
• To conduct training and coaching of the QA Compliance 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