Senior Clinical Quality Assurance Specialist

Boston Scientific • Arden Hills, MN

27d

About The Position

Your responsibilities will include: Serve as the clinical quality representative on clinical trial project teams, bringing the voice of clinical quality and fostering a continuous state of inspection readiness. Provide clinical quality consultation and respond to compliance and regulatory questions, including quality review of clinical study documents and related functional study plans. Support the Inspection Readiness Program, including inspection readiness training and coordination and participation in mock BIMO inspections and external inspections. Communicate with global clinical teams and Strategic Clinical Sourcing regarding clinical vendors, including new vendor requests, current needs, and future requirements. Evaluate responses to audit findings and ensure appropriate corrections and corrective actions are initiated and completed in a timely manner. Support divisional and global Clinical and Quality System teams during external regulatory and notified body audits. Support the CAPA program by providing quality input for assessing internal noncompliance and recommending initiation of corrections and CAPAs, partnering closely with Clinical CAPA teams and owners through successful closure. Participate in clinical and clinical quality continuous improvement initiatives and project teams. Support departmental, divisional, and corporate quality goals and priorities. Bachelor's degree with a minimum of 8 years' experience in the medical device, pharmaceutical, or other GCP-regulated industry; or Associate degree in life sciences or nursing with active registered nurse licensure and a minimum of 8 years' relevant experience. Demonstrated clinical research audit experience, or transferable experience suitable for rapid development into a clinical study or investigator site auditing role, such as clinical research associate or site monitor, clinical trial coordinator, GCP lead auditor, clinical CAPA lead, clinical research compliance professional, or clinical research SOP author. Demonstrated experience in a clinical quality and/or health care research compliance role. Working knowledge of applicable regulations and standards, including GCP, Good Documentation Practices, and privacy and security requirements for human subject research, such as 21 CFR Parts 50, 54, 56, 812, and 11; EU MDR; ISO 14155:2020 and/or ICH E6; HIPAA; and GDPR. Strong verbal and written communication skills, with the ability to engage diverse stakeholders and appropriately escalate complex or challenging issues when needed. Ability to quickly learn and adopt quality system processes and adhere to organizational codes of conduct. Strong proficiency with electronic systems, including understanding of user access controls and workflow validation processes. Ability to travel domestically and internationally up to 30%. RAQP-GCP, SoCRA, ACRP, or equivalent certification. Experience maintaining compliance within a medical device manufacturer quality system or other clinical quality system. Experience interacting with regulatory authorities such as the U.S. FDA, EU competent authorities, Health Canada, PMDA, CFDA, or BfArM. Minimum of 5 years' direct clinical quality (GCP) auditing experience. Knowledge of EU MDR requirements. Demonstrated experience collaborating across complex, cross-functional teams at all levels of the organization.

Requirements

• Bachelor's degree with a minimum of 8 years' experience in the medical device, pharmaceutical, or other GCP-regulated industry; or Associate degree in life sciences or nursing with active registered nurse licensure and a minimum of 8 years' relevant experience.
• Demonstrated clinical research audit experience, or transferable experience suitable for rapid development into a clinical study or investigator site auditing role, such as clinical research associate or site monitor, clinical trial coordinator, GCP lead auditor, clinical CAPA lead, clinical research compliance professional, or clinical research SOP author.
• Demonstrated experience in a clinical quality and/or health care research compliance role.
• Working knowledge of applicable regulations and standards, including GCP, Good Documentation Practices, and privacy and security requirements for human subject research, such as 21 CFR Parts 50, 54, 56, 812, and 11; EU MDR; ISO 14155:2020 and/or ICH E6; HIPAA; and GDPR.
• Strong verbal and written communication skills, with the ability to engage diverse stakeholders and appropriately escalate complex or challenging issues when needed.
• Ability to quickly learn and adopt quality system processes and adhere to organizational codes of conduct.
• Strong proficiency with electronic systems, including understanding of user access controls and workflow validation processes.
• Ability to travel domestically and internationally up to 30%.

Nice To Haves

• RAQP-GCP, SoCRA, ACRP, or equivalent certification.
• Experience maintaining compliance within a medical device manufacturer quality system or other clinical quality system.
• Experience interacting with regulatory authorities such as the U.S. FDA, EU competent authorities, Health Canada, PMDA, CFDA, or BfArM.
• Minimum of 5 years' direct clinical quality (GCP) auditing experience.
• Knowledge of EU MDR requirements.
• Demonstrated experience collaborating across complex, cross-functional teams at all levels of the organization.

Responsibilities

• Serve as the clinical quality representative on clinical trial project teams, bringing the voice of clinical quality and fostering a continuous state of inspection readiness.
• Provide clinical quality consultation and respond to compliance and regulatory questions, including quality review of clinical study documents and related functional study plans.
• Support the Inspection Readiness Program, including inspection readiness training and coordination and participation in mock BIMO inspections and external inspections.
• Communicate with global clinical teams and Strategic Clinical Sourcing regarding clinical vendors, including new vendor requests, current needs, and future requirements.
• Evaluate responses to audit findings and ensure appropriate corrections and corrective actions are initiated and completed in a timely manner.
• Support divisional and global Clinical and Quality System teams during external regulatory and notified body audits.
• Support the CAPA program by providing quality input for assessing internal noncompliance and recommending initiation of corrections and CAPAs, partnering closely with Clinical CAPA teams and owners through successful closure.
• Participate in clinical and clinical quality continuous improvement initiatives and project teams.
• Support departmental, divisional, and corporate quality goals and priorities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level