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Claims Quality Assurance Officer
2 months ago
We are seeking to appoint a QA Manager to join our friendly team and make a positive impact in a growing and progressive CRO. This is a fantastic opportunity to join an experienced QA team in an inclusive company that put the needs and wellbeing of their people first, and who deliver exceptional service. The focus of the job is to manage system, study and vendor audits and other QA activities to match customer expectations. You will also be involved with the rest of the QA team in the management of quality issues arising and the general QMS over all MAC’s operations, we’re looking for a strategical thinker that can plan through any given situation.
You will be largely working from home, with periodic visits to predominately UK sites, with opportunities for international travel as the company grows.
A minimum of 5 years’ experience of GCP- focused audits and other QA activities within a CRO, with some knowledge of other GXPs is essential.
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.
Ability to perform and train others in QA audits and activities within the CRO business.
A logical approach to problem analysis and solutions
Excellent initiative to be able to work alone and with a team
Good skills with MS Office
Performing and management of study, system, vendor and other types of audits.
Design and implementation of QA SOPs, in conjunction with the QA team.
Management of audit and other QA documentation and follow-up of findings
Management of quality issues arising
Management of any applicable risk assessments
Assisting the rest of the QA team in study/system/vendor audits, or any other QA responsibilities, as required
Compliance with MAC health and Safety policy
Compliance with MAC policy on equality and diversity
To maintain any professional qualifications required for the role, including continuous personal development.
To work according to MAC SOPs, guidelines and policies
To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business-related data.
MAC 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.
PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS:
Periodic UK travel to investigator sites and meetings, with opportunity to travel to international sites as the business grows. 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
