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Manager, Quality Assurance

City, York
Job Type
8 Sep 2022
SUMMARY The Manager, Quality Assurance partners strategically with quality and operational leadership to promote and support a culture of audit readiness within ACM Global Laboratories. The Manager, Quality Assurance oversees a Quality Assurance team responsible for the Quality oversite of regulated GCP & GLP activities at ACM Global Laboratories. This role offers the opportunity to lead a passionate team and deliver excellent support and results. As part of a global organisation you will gain exposure within a business that continues to grow and invest in business improvements including the opportunity to help merge and align Quality Assurance functions. Aspiration, drive and a desire to get it right first time are integral to being successful in this role. STATUS: Full Time LOCATION: Hybrid Onsite/Remote DEPARTMENT: Quality Assurance SCHEDULE: Monday - Friday ATTRIBUTES Bachelor s Degree in scientific discipline required or requisite experience. Minimum 5 years experience in quality required; experience in a laboratory, pharmaceutical or clinical research setting preferred. 2 years leadership experience strongly preferred Knowledge of, and demonstrated experience with application of, regulatory agencies Knowledge of, and or demonstrated experience with application of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, ISO15189, CAP, CLIA strongly preferred. Experience of External Client and Regulatory Inspections preferred RESPONSIBILITIES Quality Assurance. Provide guidance and oversight to the processes needed to achieve & maintain the accrediting agency/standards & regulatory requirements (as applicable) for the organization. Partner with QA Leadership to establish controls, measurements & reports for an effective compliance/risk management program, monitor & manage the compliance program. Provide input and assessment of compliance with regulations, guidelines, and Standard Operating Procedures within the organization. Partner with the organization to ensure understanding and compliance with appropriate regulations and guidance including training to all staff at an organizational wide level. Serve as an expert resource regarding regulatory requirements /accreditation standards by maintain current awareness of all required standards, laws & guidelines and monitor relevant sources for revisions/updates. Serve as the named Quality Assurance contact as required. Process Improvement. Provide appropriate QA consultation and approval for changes within the organization. Provide oversight to the development of relevant Policies, Standard Operating Procedures & processes. Management / execution of Quality Assurance required audits including internal, Referral laboratory & vendor audits to ensure adherence with internal Standard Operating Procedures & external regulations. Provide oversight & review of root cause analysis, corrective action & preventive action plans, effectiveness checks & closure of compliance issues. Assisting with & oversight of trend analysis, Quality Metrics & Key Performance Indicators (KPI) to be reported to the organization. Participate in / Lead (cross functional) teams for special projects and committees as assigned. People management. Manage staff; planning, assigning, & directing work; appraising performance, guiding professional development; rewarding & recognising employees, addressing employee relations issues & resolving problems both informally and formally. Assist in developing and monitoring Quality Assurance strategy and departmental budget
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  • Job Reference: 707260129-2
  • Date Posted: 8 September 2022
  • Recruiter: ACM Global Laboratories
    ACM Global Laboratories
  • Location: City, York
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent