Quality Assurance Manager

Responsibilities:

• Provides QA related support to all functions to ensure full success of the company’s portfolio and regulatory milestones
• Provide QA review and input to quality matters, internally and externally to ensure adherence to our regulatory obligations and maintain patient safety and data integrity during clinical trial life cycle
• Ensure clinical trials are performed in accordance with regulatory requirements.
• Manage the company Quality Management System.
• Set up and manage audits as per agreed audit programmes. Peer review of audit plans, reports and findings prepared by QA contractors to alignment with corporate SOPs and are tracked to completion.
• Facilitate the management of deviations, investigations and their associated CAPAs to closure
• Provision of quality related training to the functional depending on the business needs
• Maintain and create QA tracking systems (e.g. audit responses and CAPAs, Deviations and Investigations) as needed, ensuring they are up-to-date and accurate
• Ensuring QA awareness on key regulatory requirement changes (e.g. US CFR, EUCTD, ICH and any other local country requirements) to support evolving compliance in support of active clinical trials
• Support the development, management and implementation of Veeva QMS modules based on business needs.

Qualifications:

• Degree in life sciences, including pharmacy, chemistry, or other equivalent qualifications
• A minimum of ten years of experience in the pharmaceutical industry including with early phase clinical trials, preferably within growth phase biotechs, of which a minimum of eight must be within QA.
• Robust understanding and knowledge of global regulatory and compliance requirements for clinical research, including but not limited to UK Statutory instrument, US CFR, EUCTD, and GXPs . Awareness of other local country requirements (outside the UK, US and EMA is also required.
• Proven experience of having implemented or maintained quality systems using an electronic quality management system (eQMS) such as Veeva Quality Docs, Vault Training and QMS.
• Excellent interpersonal communication skills, both in visual presentations and in working 1:1 and with functional teams on quality matters.
• Involvement in Regulatory Inspections with the MHRA, EMA and FDA
• Involvement during in and out licensing due diligence activities from a QA perspective