The Compliance Lead is a senior member of the Quality and Compliance Team responsible for monitoring and maintaining internal compliance in line with External regulations and requirements and internal policies, in order to meet quality expectations.
An escalation point for compliance and Code queries and acts as an Any Qualified Person ( AQP, non-medical signatory)  or medical signatory.

Responsibilities:
The Compliance Lead at PharmaReview is responsible for:

Being a subject matter expert within the group and a source of advice and information to IQVIA staff on quality control processes 

Identifying quality and compliance issues, providing solutions and preventative actions

Demonstrating commitment to exploring optimal ways of working

Setting standards for the team

Development, maintenance, and training of Policies, SOPs, Work Instructions.  Liaise promptly with process owners / document authors in case of questions

Develop quality tools such as checklists and quality guidelines.

Smartsolve Quality Management System administrator

GCP Training Records management in collaboration with Training manager

Primary contact for IQVIA Quality and Compliance Team

Coordinating compliance training with the medical director / training manager including Code Clinic agendas, ‘HOT TOPICs’ and other areas of identified need

Take a leading role in providing training, guidance, and mentoring, including standardised measurements to ensure consistency across teams and best practice is adopted 

Lead role in proposing, developing, evaluating, and implementing process changes and tools and monitoring their adoption and benefits

Understanding external client’s compliance needs and ensuring internal policies and activities meet this and vice versa; collaborate with AL for onboarding and EBR on compliance aspects

Act as escalation point for Third Pair of Eyes [TPOE] review

Keep abreast of current Industry trends, knowledge, developments and advances in area e.g. attending and contributing to regulatory code compliance workstreams

Manage daily assignments, planning and directing work, and take responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff"

Contribute to budget proposals for compliance activities and maintain a clear understanding of the time and resources needed for tasks within remit

Audit Lead

 Proactive conduct regular audits to identify and document findings clearly, in accordance with defined procedures

Identify root causes, CAPA development, management and implementation and review

Develop internal controls and monitor adherence

Advising / supervising external client audits if required

Liaise with customer where required

Successful candidates will have:  
Essential skills

3-5 years relevant experience in pharmaceutical review (AQP / Sig) and / or compliance

 Strong ABPI / EFPIA / IPHA and PhRMA code knowledge

 Life Science degree or higher

Excellent written and oral communication skills

Demonstrates ability to remain calm and assertive, yet diplomatic in challenging interactions with customers and colleagues

Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges

Self-starter – ability to work under own direction with confidence

Ability to establish and maintain effective working relationships with co-workers, managers and customers at a senior level

Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers

Confidence in appropriately challenging the customer when document quality or timelines are at risk

Experienced in coaching, mentoring or managing others 

Experience working in a fast-paced environment

Experience in building strong collaborative partnerships

Experience problem solving and providing solutions

Experience working in Veeva Vault PromoMats/MedComms, Aprimo, Vodori, Ziflow or similar SaaS review and approval system

Desirable skills or qualifications: 

Masters or PhD in life sciences or industry related experience3

Signatory/AQP expertise

Medical of Pharmacist qualification

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com