Senior Quality Assurance Manager

2 weeks ago


Leeds, Leeds, United Kingdom MAC Clinical Research Full time
Job Description

Job Title: Quality Assurance Manager

Company: MAC Clinical Research

We are seeking a highly motivated and experienced Quality Assurance Manager to join our team at MAC Clinical Research. As a Quality Assurance Manager, you will be responsible for managing system, study, and vendor audits, as well as other quality assurance activities to ensure customer satisfaction.

Responsibilities:

  • Perform and manage system, study, and vendor audits
  • Design and implement QA SOPs in conjunction with the QA team
  • Manage audit and other QA documentation and follow-up of findings
  • Liaise with Sponsors and other staff as necessary to ensure efficiency and customer satisfaction
  • Keep updated with the latest regulations and guidelines relevant to the role
  • Manage quality issues arising
  • Manage any applicable risk assessments
  • Assist the rest of the QA team in study/system/vendor audits or other QA responsibilities as required
  • Host or assist with external sponsor/regulator audits as required
  • Proactive in overseeing and developing the QMS
  • Compliance with MAC Health and Safety policy
  • Compliance with MAC policy on equality and diversity
  • Maintain any professional qualifications required for the role, including continuous personal development
  • Work according to MAC SOPs, guidelines, and policies
  • Work according to current data protection standards and practice good information management. Maintain strict confidentiality of patient and business-related data
  • Maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure the job role is efficiently carried out
  • Support the aims of MAC and represent MAC appropriately in a professional way to all our customers

Requirements:

  • A minimum of 5 years' experience of GCP-focused audits and other QA activities within a CRO, with some knowledge of other GXPs
  • Experience and regulatory expertise of industry quality systems/standards, including awareness and understanding of the MHRA Phase 1 accreditation scheme
  • The ability to design, implement, report, and follow-up QA audits and other QA activities within the CRO business
  • Management and leadership experience

Benefits:

  • Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
  • Health Insurance
  • Free onsite parking
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service)
  • Your birthday off work

About MAC Clinical Research:

MAC Clinical Research is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.

Travel and Work Environment:

Periodic UK travel to investigator sites and meetings, with opportunity to travel to international sites as the business grows. Must be confident driver with full license

How to Apply:

Please email maccareers@macplc.com should you require any special arrangements or reasonable adjustments to be made throughout this selection process



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