Ashfield Healthcare

Company: Inizio Engage

Position: UK & Ireland Quality & Compliance Manager

Location: The jobholder is required to be located within the UK

Vacancy Type: Permanent - Full Time

Salary: Competitive

The UK Quality & Compliance Manager will ensure pharmaceutical and clinical/medical regulatory compliance in relation to Inizio Engage’s commercial and medical activities across a range of projects within the UK.

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. 

Key Responsibilities but not limited to 

• Identify compliance/quality risks within the organisation 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.

Essential Skills

• 5+ years’ experience in a healthcare quality and compliance  role.
• Understanding of  clinical governance.
• Experience in quality/compliance/clinical governance management or equivalent role in a commercial industry.
• Knowledge of the Association of the British Pharmaceutical Industry (ABPI) 
• 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.

Background

At Inizio Engage you’ll find a challenging, fast-paced and rewarding environment, but also one that’s caring, nurturing and supportive. With so many ways to support patients and healthcare professionals, we offer a range of exciting career opportunities to suit your skills and interests. Whether working remotely, in the office, or in the field, you’ll find everything you need at Inizio Engage to build a successful career. Excited yet? We are!

Inizio Engage is an equal opportunity employer, and employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of gender, sexual orientation, marital or civil partner status, gender reassignment, race, religion or belief, nationality, ethnic or national origin, disability, age, pregnancy.

Please note if you have not heard from a member of the resourcing department within 7 days your application has been unsuccessful at this stage.

Thank you for your interest in Inizio Engage.