AddressDuties & 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.
- 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.
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