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Manager I, Clin QA - 101041 - Valencia, CA - 0300
Description
1) Purpose/Role Statement
2) Key Responsibilities
· Provides GCP compliance guidance to clinical teams under the direction of the head of CQA GCP group and CQA Director, and according to standard CQA GCP and CQS processes and practices
· Maintains the audit schedule and analyzes audit findings for trends.
· Reviews SOPs to assure compliance with regulations and BSC policies and procedures.
· Provides input to training function and, where appropriate, gives training on issues identified during audits.
· Works with the head of CQA GCP group and CQA Director to develop clinical audit procedures and processes.
· As needed, assists with internal and external audits (internal systems, trial master file, investigator sites, clinical service providers, Clinical Study Reports (CSRs) and other critical clinical documents for regulatory submission [Annual Reports, etc.]) to assess compliance to quality systems processes that ensure patient safety and the quality and integrity of scientific data collected, and to determine the level of compliance with applicable regulations.
· Reviews CQA audit reports generated by CQA auditors or contractors for accuracy and consistency.
· Reports on noncompliance signals to the head of CQA GCP group and CQA Director promptly.
· Supports the monitoring team by providing “for cause” audit support as an escalation process for clinical sites where compliance is not adequately maintained within the monitoring systems.
· Prepares clinical sites for FDA or other regulatory agency inspections, coordinates sponsor activities during clinical site inspections by regulators and assists in preparation of written responses to inspection findings, when appropriate.
· Keeps abreast of global regulatory requirements impacting GCP compliance, and updates management on the possible ramifications of regulatory changes.
· Contributes to the development of department plans and budgets, and monitors spending.
· Recruits, trains, supports, and develops junior Clinical Quality Assurance staff (Auditors and Specialists).
3) Quality Systems Duties and Responsibilities (if not already detailed above)
· Co-audit with CQA Specialist to ensure that there is an understanding of and consistency in executing the CQA audit process.
· Assists in training Clinical Sciences staff and/or contractors in GCP compliance requirements, as needed.
· Summarizes and analyzes CQA audit data for trends.
· Reviews essential documents such as protocols, CRFs, and informed consent forms for adequacy and compliance with GCP regulations and guidance.
· Engages, trains, and supervises contract auditors, as necessary.
· Establishes and supports a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for Clinical Quality Assurance.
· Ensures all employees are trained to do their work and their training is documented in the required timeframes.
4) Qualifications
Minimum Education and Experience:
· Bachelor’s degree in science or health-related field required or equivalent experience in clinical research GCP auditing.
· Minimum of 7 years’ experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; 5 years’ QA and/or compliance auditing experience; 0-3 years prior QA GCP management experience; international experience a plus.
· Zero to two years’ QA GCP management experience or equivalent required.
· Understanding of and compliance experience with CFR 21 GCP regulations and guidance, Medical Device Directive, ICH E6 GCP required, ISO 14155 and Japanese GCP regulations experience a plus.
Working Conditions:
General office environment. Up to 50 percent domestic and international travel expected.
