This listing was posted on The Resumator.
Manager, Laboratories
Location:
Woolloomooloo, NSW
Description:
Job Summary The Manager, Laboratories, will provide leadership and oversee the day-to-day operations for Prove Clinical Laboratories (PCL). This position will direct laboratory staff (including Senior Scientists and Project Managers) to ensure efficient and consistent operations within the laboratory. This position is full-time in the laboratory. Duties & Responsibilities Provide leadership, oversight and guidance to PCL employees to ensure quality, timeline, resources and budget goals are met by our laboratory. Lead the laboratory by working with Project Managers, GxP Systems Applications, vendors, and clients to troubleshoot problems as they affect laboratory operations; given the development stage of PCL, performing hands on laboratory tasks are required when needed. Sign off and approval responsibility for validation reports and review of non-diagnostic patient reports as needed. Develop and implement a plan to streamline operations to align with growing business demand, including design and execution of validating testing. Establish and nurture an organizational culture of continuous improvement within a regulated operating environment, work with the laboratory staff to ensure Corrective Actions and Preventative Actions (CAPAs) are developed and implemented in a timely manner to address deviations as they occur through close collaboration with the laboratory Quality Assurance team. Oversee, plan, and implement quality checks (QC) for projects and provide leadership and direction to ensure the highest standards for compliance with PCL’s policies and SOPs, regulatory authority regulations, and safety standards. Partner with Quality Assurance personnel to build a transparent, learning-based quality culture, and to execute and maintain continued compliance with Quality Management System (QMS), NATA, ISO standards, and applicable regulations; Including maintaining and expanding existing NATA accreditation, and obtaining new accreditation as required. Approval of laboratory policies, SOPs, guidelines and job aids in collaboration with laboratory Quality Assurance team, and team members, with responsibility for review and update processes. Recruit, retain, mentor, and develop employees by conducting performance management activities for laboratory associated staff. Monitoring laboratory KPIs; compile and analyse trending and statistical reports for the laboratory to present to management at business review, quality management review meetings or other settings as required. Required Qualifications Bachelor’s degree in Science/Medical Laboratory Sciences, and 5+ years’ experience as a multiskilled scientist in a laboratory environment, including: Process and systems validation. Handling, operating, and troubleshooting lab equipment. Must be multiskilled in different laboratory testing disciplines, preferably on: Pathology Pharmacokinetics and Pharmacodynamics Biomarkers Must have in-depth and current regulatory knowledge of a central laboratory, particularly on ISO 17025; Familiarity on ISO15189 and GLP would be desirable A thorough knowledge of Clinical Trials, including clinical research concepts, practices, applicable regulations, clinical study design, and data management methods. Experience leading a rapidly changing organization, a proven dynamic leader with strong interpersonal and management skills who can work effectively at all levels of an organization and deliver results; ability to build strong collaborative relationships with business unit heads and functional managers. Possesses high ethical principles and conducts business in the most professional manner. Demonstrated customer service experience and skills, preferably in a laboratory environment, including the ability to communicate effectively with customers and clinical project operations. Powered by JazzHR
Company:
Prove Clinical Laboratories
Posted:
April 4 on The Resumator
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