Quality and Compliance Manager (Pharmareview)

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:

• 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 standardized 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 the 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.
• 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:

• 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 experience.
• Signatory/AQP expertise.
• Medical or 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.