Head of GxP Audit
3 weeks ago
Job Introduction
Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- 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.
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 hearfrom those who have/are:
- 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 ofrequirements and guidance for the development, manufacture, control, and distribution of commercial product.
Dechra is a global specialist in veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide. We are a global leader in veterinary endocrinology and topical dermatology, have a broad portfolio of analgesia, anaesthetics and products for the treatment of pain, and are also recognised as innovators in other specialisations such as the treatment of equine lameness, nutrition and differentiated generics. We deliver high quality products and services to veterinarians worldwide through our employees and a network of third parties to sustainably improve global animal health and welfare. Everything we do is underpinned by our Culture and Values . They are important to us and have helped drive the Group's success. Dechra Pharmaceuticals PLC #J-18808-Ljbffr
-
Senior Manager, Auditor
1 day ago
United Kingdom Workingmums Full timeJob Description: Senior Manager Auditor Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development,...
-
Global Head of Technology Audit
13 hours ago
united kingdom Broster Buchanan Full timeHead of Technology Assurance - Once in a career opportunity. A superb opportunity to join a FTSE listed organisation within a senior leadership role, working closely with the Group Head of Assurance.Responsible for the planning and overseeing the end-to-end delivery of technology, security and integrated audits. This will consider all areas of the Groups...
-
Pharmacovigilance Auditor
1 month ago
United Kingdom Parkside Recruitment Full timeSenior Manager Global Quality Operations (Senior PV Auditor) This is a home-based role offering a fantastic package including generous salary, incentive bonus, home based allowance plus much more. My client a Global pharmaceutical company are seeking an experienced Senior Manager, Global Quality Operations to manage and perform audits with focus on...
-
Pharmacovigilance Auditor
1 month ago
United Kingdom Parkside Recruitment Full timeSenior Manager Global Quality Operations (Senior PV Auditor) This is a home-based role offering a fantastic package including generous salary, incentive bonus, home based allowance plus much more. My client a Global pharmaceutical company are seeking an experienced Senior Manager, Global Quality Operations to manage and perform audits with focus on...
-
Associate Director
1 month ago
United Kingdom Worldwide Clinical Trials, LLC Full timeWho we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...
-
Senior Audit
5 days ago
United Kingdom Expleo Group Full timeAre you currently looking for a new career opportunity within Automotive Auditing? Are you keen to work within an Automotive OEM? Expleo Engineering are seeking a Head of Audit to support the improvement of the vehicle auditing, the management of systems working towards a zero repeat issue culture. This will be a permanent role based at our clients site in...
-
Senior Manager Auditor
1 day ago
United Kingdom Workingmums Full timeJob Description: Senior Manager Auditor Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development,...
-
Regulatory Auditor
1 month ago
United Kingdom Parkside Recruitment Full timeSenior Manager Global Quality Operations (Senior PV Auditor) This is a home-based role offering a fantastic package including generous salary, incentive bonus, home based allowance plus much more. My client a Global pharmaceutical company are seeking an experienced Senior Manager, Global Quality Operations to manage and perform audits with focus on...
-
Auditor (Contract)
1 month ago
United Kingdom Parkside Recruitment Full timeSenior Manager Global Quality Operations (Senior PV Auditor) This is a home-based role offering a fantastic package including generous salary, incentive bonus, home based allowance plus much more. My client a Global pharmaceutical company are seeking an experienced Senior Manager, Global Quality Operations to manage and perform audits with focus on...
-
Head of IT Audit Manager
1 week ago
United Kingdom Eames Consulting Full timeYou will lead and coordinate the internal audit process for IT audit for all entities within the Group The scope includes both global and regional processes and working with colleagues within the company and externally with partnering firms. As a senior lead in the audit function there is also opportunity to lead an audit domain for the Group as a whole,...
-
Associate Director
1 month ago
United Kingdom Worldwide Clinical Trials, LLC Full timeIt is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. What Associate Director Quality...
-
Senior Manager, Auditor
6 days ago
United Kingdom Pfizer, S.A. de C.V Full timeTo fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. At Pfizer, compliance is more than just a routine; it's a relentless pursuit of excellence, safeguarding our values...
-
Senior Manager Auditor
6 days ago
United Kingdom Pfizer, S.A. de C.V Full timeWe’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about...
-
Cybersecurity and IT Audit Manager
1 week ago
United Kingdom Barclay Simpson Full timeBarclay Simpson is recruiting an IT Audit Manager for a multinational financial services organisation in London. Reporting directly to the Senior IT Audit Manager, this position will support both the UK and US Heads of Audit, providing risk-based audit coverage alongside independent assessments of key controls, risk management and processes across the...
-
Director of Quality Assurance GCP
3 weeks ago
United Kingdom Albion Rye Associates Limited Full time3 days ago Be among the first 25 applicants Save this job with your existing LinkedIn profile, or create a new one. Save this job with your existing LinkedIn profile, or create a new one. Your job seeking activity is only visible to you. Email Welcome back Sign in to save Director of Quality Assurance GCP at Albion Rye Associates . Direct message...
-
Audit Manager
4 days ago
United Kingdom Association of International Certified Professional Accountants Full timeYour new firm An established firm based in Northwich are seeking to recruit an experienced Audit Manager to join their growing team. This firms provides accountancy and audit services to a range of local clients that mostly sit within farming, education, and charity sectors. This role has came about due to the firm growing their client base within the...
-
Internal Audit Manager
1 month ago
United Kingdom Groupe BPCE Full timeTo verify the bank's controls and to periodically check and assess by means of audit assignments the completeness of coverage, consistency and correct functioning of the risk control systems in place, as well as their compliance with professional rules, regulations, practices and standards in force. Carry out a comprehensive assessment of systems and...
-
IT Audit Manager
1 week ago
United Kingdom Barclay Simpson Full timeBarclay Simpson is recruiting an IT Audit Manager for a multinational financial services organisation in London. Reporting directly to the Senior IT Audit Manager, this position will support both the UK and US Heads of Audit, providing risk-based audit coverage alongside independent assessments of key controls, risk management and processes across the...
-
Asst. Audit Manager
10 minutes ago
United Kingdom Adecco Full timeAudit Assistant/Administrator Contract to March 2025 London/Hybrid £160 per day PAYE Our commitment is to provide equal opportunity regardless of, for example, your gender, age, ethnicity, disability, sexual orientation or beliefs. We also engage with employers to develop programmes and pathways that embrace diverse talent and promote more inclusive...
-
Senior Audit Manager or Manager
1 week ago
United Kingdom Barclay Simpson Full timeA major banking organisation is recruiting a Senior Audit Manager to join their team in London. Working as part of the markets and treasury team and reporting to the Head of Internal Audit, this role will be responsible for undertaking ongoing monitoring of key elements related to the financial markets and capital markets portfolio. Internal audit...