Senior QA Auditor

At ICON, we have an incredible opportunity for an expert Senior Pharmacovigilance (PV) QA Auditor to join the team in our Southampton offices.

As a Senior PV Auditor, you will be responsible for tasks assigned to the Quality and Compliance function such as internal audits, vendor audits, regulatory and sponsor inspections and defence audits and CAPA Management.

This role will include post COVID travel of up to 35%.

The Role

• Plan and conduct regular internal audits and for cause audits of the ICON pharmacovigilance quality system in order to evaluate the quality system against the requirements appropriate regulations and applicable guidelines
• Perform the role of a lead auditor to assess the effectiveness of the pharmacovigilance quality system and to verify that the quality system is being implemented
• Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented
• Train QA auditors, and provide a standard for auditing to inexperienced or less experienced colleagues
• Carry out a senior role in the PV QA department, such as scheduling of audits
• Lead Sponsor Audits and/or Regulatory Inspections of ICONsafety-related activities;
  • Preparation activities including liaising with the client, identifying, escalating and mitigating any risks and preparing operational teams
  • Host Sponsor on-site or remote audits including leading opening and close out meeting activities, supporting operational targets in audit defence activities, escalating potential issues as needed, and providing audit summaries to senior management
  • For regulatory inspections of ICON, lead / assist with the leadership of the on-site inspection activities: lead document request activities and/or act as 'back room' leader, lead inspection room activities on behalf of the Q&C Manager / Director, when needed, including direct communication with the inspectors
• Lead Quality Issues investigations, root cause analysis (RCA) and resulting CAPAs management, including;
  • Lead RCA and investigation meetings with relevant operational responsible teams
  • Support quality and regulatory compliance and escalation management processes including ensuring the timely escalation of suspected scientific misconduct and potential serious breach notifications
  • Manage ongoing investigations based on the specifics of each individual case in a structured manner and as per relevant work instructions
• Conduct departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training
• Liaise with clients and operational persons including managers on quality aspects which may include attendance at meetings, presentations and audits

What you need

• Experience in Pharmaceutical and/or GVP environment including in-depth knowledge and experience in PV Quality Assurance auditing and/or with relevant regulatory compliance /Quality System, including quality system development and leading system development projects
• Thorough knowledge of relevant GVP regulations
• Ability to review and evaluate safety-related data/records/systems/processes
• Thorough knowledge of pharmacovigilance and clinical trial related safety activities
• Thorough knowledge and experience in performing and leading Root Cause Analysis.
• Ability to manage complex issues and related CAPAs, including leading large cross functional teams, task prioritization, and project management as needed
• Demonstrated coaching, mentoring & training skills, including the ability to give constructive feedback
• Ability to work as part of a team
• Highly developed problem solving skills, and the ability to resolve difficult situations
• Well-developed interpersonal and communication skills (oral and written) with prior experience conducting presentations or facilitating meetings

Why join us?

Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Ongoing development is vital to us, and as a Senior PV QA Auditor, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/colour/religion/sex/sexual orientation/gender identity/disability/vet/national origin