Clinical quality assurance manager / director
The clinical quality assurance manager / director will join the quality team and report directly to vp of qualityThis person is responsible for assuring the quality of clinical development systems, processes and related activitiesThis position plays a lead role within marker’s gcp qa process, works closely across marker quality, regulatory and clinical teams to ensure that ongoing clinical trials meet global regulatory and business requirementsThis position represents the company both internally and externallyLastly, the position helps to drive a ‘culture of quality’ at marker.
Position responsibilities
Develop, lead, implement and maintain marker’s gcp qa audit program to support aspects of phase i-iv us-based clinical trial.
Lead qualification, routine and for-cause audits of clinical research organizations (cro), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their qms and compliance to approved clinical study protocols and contracts.
Conduct clinical study report (csr) and trial master file (tmf) audits.
Maintain the approved supplier list (asl) for clinical suppliers.
Ensure timely issuance of audit reports, audit observations, oversee audit response process and drive audits to closureEvaluate audit observation trends and escalate as required to quality, regulatory and clinical departments heads.
Prepare and lead the cross functional site quality management review (qmr) meetings
Prepare quality agreements for review and approval by quality, clinical and regulatory departments heads.
Ensures all cro’s operate in a state of quality compliance.
Ensures deviation and change management processes are utilized to manage quality events that impact on delivery of accurate and consistent dossiers and submissions.
Quality approval of clinical research organizations and supporting suppliers for the delivery of clinical trial activities.
Management of documentation flow for clinical qa activities with above providers including change management, deviations and non-conformance.
Lead/support continuous improvement activities and conduct internal training on clinical quality standards and regulations.
Ensure quality incidents are fully investigated, root cause analysis is defined and that capa has been implemented and monitored for effectivenessProvide data to assess risks, quality metrics and capa learnings at applicable qmr.
Perform quality documents review (eG sops, instructions).
Maintaining current working knowledge of regulations that may have impact on role.
Other duties as assigned.
Skills, education and experience required
Minimum ba/bs degree in, preferably, biological sciences, or related field
Seven or more years of industry (pharmaceutical, cell and gene therapy, medical devices) experience and strong experience in clinical quality auditing.
Thorough understanding of international guidelines (ich, cgcp) including study conduct, statistics and data management.
Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice.
Demonstrated ability in using continuous improvement techniques to contribute to a pharmaceutical qms (e.gRoot cause analysis, etc.)
Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts.
Strong analytical, project management skills.
Experience with edocument management, training, capa’s, audit systems and tools.
