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Spencer Gregory Hale
Your responsibilities will include:
Participates in clinical project teams, and always influences clinical teams toward a state of inspection readiness
Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials
Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures
Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials
Participates in problem-solving with clinical project teams at investigator sites
Communicate observations to clinical investigators and clinical program managers
Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed
Ensures tracking of audit findings
Contributes to the development of audit procedures and processes
Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives
Assists in the preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings
Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes
Support the Clinical organization in meeting BSC Quality system requirements
Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners and providing quality input
Partner with Clinical to support supplier and BSC-related nonconformances by performing the following activities (NCEP, CAPA, SCARS):
Conduct root cause analysis
Determine corrective and preventive actions
Determine verification of effectiveness actions to support the corrective and preventive actions
Support IC CQA portfolio activities and quality system deliverables for IC CQA, including but not limited to quarterly audit schedule updates, management of IC CQA surveillance activities, communication of quality signals to quality leads and clinical leadership, and coordination of clinical and clinical quality QMR deliverables for ICTx and WM.
Proactively drive clinical compliance, making data-driven decisions to facilitate process improvement and a proactive quality culture.
Participates in the development, implementation, and maintenance of global quality systems. Works to identify ways to improve compliance with regulations and BSC policies and procedures for CQA
Quality System Requirements:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
What we're looking for in you:
Required Qualifications:
Bachelor’s degree in science, health, engineering or a relevant field of expertise
5-7 years of work experience with quality systems/controlled processes
Previous experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines
Strong presentation, communication, and critical thinking skills
Strong understanding of Quality Systems
Working knowledge of ISO 14155 and GCP
Working knowledge of ISO 13485
NCEP, CAPA, and Supplier Corrective Action experience
Preferred qualifications:
Working knowledge of US and International regulations and standards applicable to BSC
Additional quality certifications from ASQ, SOCRA, RQAP-GCP, etc.
Experience working cross-functionally with multiple stakeholders
NCEP, CAPA, and Supplier Corrective Action experience
Ability to collaborate and influence across multiple, cross-functional teams
Maximum Salary: $ 164500
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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