Senior Quality Assurance Manager
2 weeks ago
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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