Original Job Description:
https://www.cv-library.co.uk/job/220471228/Manager-Quality-Assurance
Locations:
– North Yorkshire, York, City of York, YO1, GB
HOW WE CARE FOR YOU:At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster employee wellbeing, professional development and personal growth. We care for your career while improving patients’ lives. Auto Enrolment Pension Comprehensive Benefits Package Career Advancement Opportunities including Apprenticeships Comprehensive Career PathwaysSUMMARY: The Manager, Quality Assurance partners strategically with quality and operational leadership to promote and support a culture of audit readiness within ACM Global Laboratories.ACM Global Laboratories is a growing international organization that provides continued opportunities for internal advancement. At ACM you will be part of a team that is focused on improving people’s lives where you are supported by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding field of advanced laboratory science. Your voice is heard, and with that, you have an ability to make an impact on the organization and influence your professional growthSTATUS: Full TimeLOCATION: Hybrid – York, UKDEPARTMENT: QualitySCHEDULE: DaysATTRIBUTES: 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) required. Knowledge of, and or demonstrated experience with application of MHRA, FDA, ISO15189, CAP, CLIA preferred. Experience of External Client and Regulatory Inspections preferredRESPONSIBILITES: Leadership 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 Quality Assurance 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. Provide guidance and oversight to the processes needed to achieve & maintain the accrediting agency/standards & regulatory requirements (as applicable) for the organization. Act as Archivist/Deputy Archivist to ensure Compliance 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/updatesDisclaimer: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
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