Quality and Compliance Manager (Pharmareview)

Nanosep AB; London; On-site; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Compliance Lead to join their Quality and Compliance Team. In this pivotal role, you will ensure adherence to internal policies and external regulations while driving quality initiatives. Your expertise will guide teams in navigating compliance challenges, and you will play a key role in developing and implementing quality tools and processes. With a focus on continuous improvement, you will lead audits and training efforts, ensuring that best practices are followed across the organization. Join a forward-thinking company dedicated to enhancing patient outcomes and making a global impact.

Qualifications

• 3-5 years of experience in pharmaceutical review and compliance.
• Strong knowledge of ABPI, EFPIA, and PhRMA codes.
• Life Science degree or higher qualification.

Responsibilities

• Advise on quality control processes and compliance issues.
• Conduct regular audits and document findings.
• Provide training and mentoring to ensure best practices.

Skills

Pharmaceutical Review

Compliance Knowledge

ABPI / EFPIA / IPHA Codes

Written and Oral Communication

Problem-Solving Skills

Coaching and Mentoring

Initiative and Sound Judgment

Relationship Management

Education

Life Science Degree

Masters or PhD in Life Sciences

Tools

Veeva Vault

Aprimo

Vodori

Ziflow

Job description

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 internal policies to meet quality expectations.

They serve as an escalation point for compliance and Code queries and act as an Any Qualified Person (AQP, non-medical signatory) or medical signatory.

Responsibilities:

• Be a subject matter expert within the group and advise IQVIA staff on quality control processes.
• Identify quality and compliance issues, provide solutions, and implement preventative actions.
• Explore and implement optimal ways of working.
• Set standards for the team.
• Develop, maintain, and train on Policies, SOPs, and Work Instructions; liaise with process owners/document authors as needed.
• Create quality tools such as checklists and guidelines.
• Administer the Smartsolve Quality Management System.
• Manage GCP Training Records in collaboration with the Training Manager.
• Act as the primary contact for the IQVIA Quality and Compliance Team.
• Coordinate compliance training with the medical director/training manager, including Code Clinic agendas and ‘HOT TOPICs’.
• Provide training, guidance, and mentoring to ensure consistency and best practices across teams.
• Lead in proposing, evaluating, and implementing process changes and tools, and monitor their adoption and benefits.
• Understand external client compliance needs and ensure internal policies meet these requirements; collaborate with AL for onboarding and EBR on compliance aspects.
• Serve as an escalation point for TPOE review.
• Stay updated on industry trends, regulations, and developments.
• Manage daily assignments, plan and direct work, and oversee workload for projects and tasks in collaboration with senior staff.
• Contribute to budget proposals for compliance activities, understanding resource requirements.

Audit Lead:

• Conduct regular audits proactively, documenting findings clearly per procedures.
• Identify root causes, develop CAPAs, and review their management and implementation.
• Develop internal controls and monitor adherence.
• Supervise external client audits if required and liaise with customers accordingly.

Successful candidates will have:

Essential skills:

• 3-5 years relevant experience in pharmaceutical review (AQP/Sig) and/or compliance.
• Strong knowledge of ABPI / EFPIA / IPHA and PhRMA codes.
• Life Science degree or higher qualification.
• Excellent written and oral communication skills.
• Ability to remain calm, assertive, and diplomatic in challenging interactions.
• Initiative and sound judgment in unfamiliar situations.
• Self-starter with the ability to work independently.
• Effective at establishing and maintaining relationships with colleagues and clients at all levels.
• Proactive in evaluating risks and discussing solutions.
• Confidence to challenge clients when document quality or timelines are at risk.
• Experience in coaching, mentoring, or managing others.
• Experience in fast-paced environments and building collaborative partnerships.
• Strong problem-solving skills.
• Experience with SaaS review systems like Veeva Vault, Aprimo, Vodori, Ziflow.

Desirable skills or qualifications:

• Masters or PhD in life sciences or related industry experience.
• Expertise as a Signatory/AQP.
• Medical or Pharmacist qualification.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We aim to accelerate medical development and improve patient outcomes worldwide. Learn more at https://jobs.iqvia.com.

We value diverse talent with curious minds and a commitment to innovation. Everyone at IQVIA contributes to our mission of improving lives globally.

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