Head of GxP Audit & Compliance

Northwich, Cheshire
Dechra Pharmaceuticals PLC
Summary

Dechra Pharmaceuticals are looking for an experienced auditing professional to join our manufacturing division on a remote basis.

Support the GxP and Regulatory compliance of Dechra Products by developing audit systems which will ensure process and product compliance with applicable GMPs/GDPs throughout the product lifecycle.

Develop, approve, and monitor the risk based GxP audit programme and budget for Dechra DPMS. Develop and support inspection readiness at Dechra Internal Manufacturing sites, sustaining their ability to successfully conclude regulatory inspections for Dechra’s products.

Provide US and European regulatory intelligence, train Subject Matter Experts and provide internal consultancy for quality compliance implementation and FDA/EU GMP/GDP remediation projects in the Dechra Internal Manufacturing network.

Frequent global travel is required with this role, and you will need to travel to our Northwich site once a month.

Main Responsibilities

• Support all regulatory authority inspections at Dechra Internal Manufacturing Sites and at key Identified External Network Manufacturing Sites by providing expertise (e.g., stress tests, mock inspections, inspection preparations, backroom support and review or preparation of responses to deficiencies) and on-site presence as required.
• Develop audit systems to ensure key elements of the Dechra GxP Quality Management System and the requirements of the product licences / marketing authorisations are effectively implemented throughout the internal and external manufacturing network (as required) across the product’s registered lifecycle in compliance with all applicable ISO, ICH, FDA, EU, and national regulatory requirements for GMP/GDP.
• Lead GMP/GDP audits for Dechra DPMS based on specific expertise, criticality, and complexity.
• Periodically assess the liability, regulatory and/or quality risk to Dechra’s products, reputation, and operating licenses through the programme of audits and risk assessments, escalating and reporting the results accordingly.
• Maintain oversight of the Dechra DPMS audit master schedule and coordinate the audit planning with the wider audit team and Group Risk Management to ensure that products currently marketed, supply chain optimisation exercises, service providers as well as transportation and distribution networks are all being adequately monitored.
• Recruit, lead, train and develop, as required, the team of quality and compliance experts (specialised in auditing different GMP/GDP areas) across the business, to keep the business abreast of ongoing developments through benchmarking activities, whilst proactively identifying and addressing any gaps relating to product quality and GxP compliance.
• Support the Dechra DPMS Quality groups as well as the Dechra functional specialties (Product Development, Regulatory Affairs, Business Development, Procurement and Commercial Operations) by providing subject matter expertise, review(s) and in-house consultancy on request.
• Provide Group Quality Director with a fully independent and autonomous investigative and report that provides a clear liability and risk assessment related to quality and GMP/GDP regulatory compliance.
• Disseminate regulatory intelligence related to industry best practice, upcoming regulations, audit/inspection trends as well as general QMS training and product quality knowledge.
• Support the QMS Manager in the configuration of the eQMS supplier qualification, audit, and inspection processes within the eQMS system.

Ideal Candidate

• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Pro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracy.
• Formal Auditing qualification e.g. IRCA accredited Lead Auditor course or Certified Quality Auditor (CQA) through American Society for Quality is desirable.
• Proven ability as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in “win-win” outcomes to achieve business goals and objectives.
• Proven ability of accurate and timely completion of tasks.
• Educated to Degree level (or equivalent qualification) in Chemistry, Biology, Pharmacy, Pharmaceutical Science, Life Science, or comparable discipline.
• Ability to multi-task, set priorities and meet strict deadlines.
• Using logic and reasoning to identify solutions to problems.
• First class organisational skills.
• Self-motivated, with the ability to work proactively using own initiative.
• At least 10 years of experience in pharmaceutical industry with hands on experience in or supporting operations.
• Experience of auditing quality systems / manufacturing / releasing for a variety of pharmaceutical dosage forms (including aseptic parenteral products).
• Hosted or supported multiple regulatory inspections by FDA, MHRA, EMA and other regulatory agencies.
• Excellent working knowledge of FDA and EU GMPs/GDPs, especially in the interpretation of requirements and guidance for the development, manufacture, control, and distribution of commercial product.