PLM has an outstanding opportunity for a Quality Assurance professional to join the team that is responsible for PLM’s Clinical Operations. The Senior Manager, Quality Assurance, Clinical Operations, reporting into the VP, Senior Medical Advisor, will be highly collaborative, working broadly across the organization with internal stakeholders, most notably Clinical Operations, Biocomputing, Translational Medicine, Omic Vendor and Data Science. The Senior Manager will be critical in ensuring that operations under PLM’s research portfolio are in compliance with regulatory/quality system requirements.
Provide quality oversight to the clinical operations and science team.
Monitor clinical operations and corresponding activities, including project timelines and quality of deliverables.
Supports and assists clinical development activities of new studies. Ensures clinical studies adhere to pertinent regulations through review of monitoring reports. Provide and assists with the development of procedures and processes associated with all clinical activities related to the acquisition, management and processing of human bio-specimens. Ensure proper management of deviations and perform routine review of all adverse quality events.
Demonstrate strong proficiency in the application of the corrective and preventive action system to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources.
Represent PLM during audits and perform internal and external auditing.
Participate in SOP development and revision.
Create and manage metrics for dashboards supporting trends.
BS/BA Degree in relevant discipline.
Minimum 5 years quality assurance experience, preferably in Biotech, Diagnostics, or related Health-Care Industry.
Clinical Trial design and support experience.
Experience or familiarity with multiplex omics preferred.
Ability to effectively interface with internal and external teams.
Experience with managing QA activities across multiple quality system requirements (EG: CLIA/CAP).
Ability to learn new software/technology quickly.
Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
Develops and maintains strong working relationships with internal stakeholders. Demonstrates strong interpersonal communication skills, ability to work in a team environment and excellent organizational skills. Ability to help scale functional area to include automated quality control.