Ashfield Healthcare

Job Purpose/Overview:

The UK and Ireland Quality & Compliance Manager will ensure pharmaceutical and clinical/medical regulatory compliance in relation to Inizio Engage’s activities within the UK & Ireland.

The jobholder will develop, implement, maintain, and improve consistent, fit-for-purpose compliance and quality systems and procedures, and where appropriate, will implement policies/SOPs/training, embedding a compliance and quality culture across the business. The jobholder will ensure pharmaceutical and clinical/medical regulatory compliance/quality assurance in relation to Inizio Engage. A member of the global Quality & Compliance ("Q&C") team the jobholder will provide oversight of the Q&C program for the UK.  The role will have strong Q&C expertise and provide strategic oversight and alignment for the UK in development of the global Q&C plan and strategy.  The jobholder will have Q&C management and leadership experience.

Duties & Responsibilities: ( but not limited to ) For a full job description and for the opportunity for us to bring this to life, please contact us .

• Identify compliance/quality risks within the organization and partner with the business to devise remedial actions.

• Responsible for ensuring the company is compliant with the rules and regulations of regulatory agencies and that company policies and procedures are developed, maintained, and followed,            both on a global and local basis.

• Promote a proactive Q&C culture throughout the company.

• Design, implement, monitor and enforce compliance and risk policies and standards. 

• Act as a compliance subject matter expert with regard to clinical regulatory requirements for company services.

• Host client and regulatory audits with proven experience and a partnership approach.

• Research relevant regulations, codes of practice and best practice, including horizon-scanning, and update relevant personnel (including proposed solutions)

• Act as a vocal and strong member of the UK leadership team and the global Q&C team to partner with the business to achieve local and global strategic goals.

• Develop, implement, maintain and improve consistent, fit-for-purpose compliance and quality systems and procedures, via an appropriate electronic or manual QMS, including but not limited to document control and document management/review, training schedules and training records procedures, deviations and complaints/incident handling procedures and audit procedures.  

• Ensure programme documentation and training materials/validations are in place in liaison with relevant personnel.

• Responsible for partnering with business leads to identify compliance process improvements in all business units. 

• Q&C review of contracts and quality agreements.

Requirements & Qualifications:

• 5+ years’ experience in a healthcare quality and compliance leadership role.

• Experience in clinical governance, preferred.

• Experience in quality/compliance/clinical governance management or equivalent role in a commercial industry.

• Knowledge of the Nursing and Midwifery Code of conduct and Nursing and Midwifery Board of Ireland useful, but can be trained plus 

        Excellent knowledge of both the Association of the British Pharmaceutical Industry     (ABPI) and the Irish Pharmaceutical Healthcare Association (IPHA) codes.

• Excellent interpersonal and communications skills with the proven ability to serve in a leadership role, both verbal and written.

• Proven planning/organisational skills, ability to handle multiple projects simultaneously and ability to meet tight timescales/deadlines Must be adaptable, numerate, literate and be willing and              quick to learn with the desire to succeed.