Senior Specialist Clinical Quality Assurance

Your responsibilities will include:

Clinical Compliance – Hands-on partnership with Clinical for clinical quality consultation and inspection readiness:

• Provides clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness
• Provides support and response to compliance and regulation questions including quality review of clinical study documents and related functional study plans
• Supports Inspection Readiness program to include inspection readiness training and coordination/participation in Mock BIMO inspections as well as external inspections
• Communicates with global clinical teams and Strategic Sourcing regarding clinical vendors, new clinical vendor requests, current clinical vendor needs, and future needs

Independent Auditing:

• Creates risk-based study audit plans; plans, schedules, and conducts internal clinical quality audits, clinical process audits, investigator site audits, and clinical vendor audits to assure BSC clinical investigational trials and post market studies comply with applicable regulatory requirements, quality and GCP standards, and BSC policies and procedures
• Documents and communicates audit observations; evaluates impact and makes recommendations for corrections and/or corrective actions. Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated and completed
• Keeps abreast of and interprets current worldwide regulatory requirements; advises various stakeholders regarding possible ramifications of regulatory changes

Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements

• Supports Clinical and QS team during External Regulatory/Notified Body audits
• Supports the CAPA program, providing quality input for assessing internal noncompliance and recommending initiation of corrections/CAPAs, working closely with Clinical CAPA team and CAPA owners through to successful closure
• Participates on clinical process improvement projects and initiatives
• Provides review and comment to relevant BSC procedure revisions
• Supports departmental, divisional, and corporate quality goals and priorities
• Initiates and/or collaborates on continuous improvement projects related to the BSC Clinical Quality Management System.

Acquisition integration:

• Represents Clinical Quality on clinical acquisition/integration teams for identification, assessment, and mitigation of risks associated with the transfer of sponsorship of clinical studies from acquired entities, supporting development and execution of a clinical integration plan, transfer of quality systems, and compliance to GCP and applicable regulations with aim to ensure subject safety and integrity of study data.

What we’re looking for in you:

Minimum Qualifications:

• Minimum of a bachelor’s degree with minimum of 8 years’ experience in the medical device, pharmaceutical, or other industry in an area regulated by GCP regulations and guidelines; OR in the alternative, a life science or Nursing Associate Degree with active Registered Nurse licensure and at least 12 years of relevant experience
• Demonstrated clinical research audit experience or suitability to quickly train into clinical study/investigator site auditing role, with one or more of the following proficiencies: clinical research associate/site monitor, clinical trial primary research coordinator, GCP lead auditor, CAPA leader, research compliance, and clinical research SOP author
• Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance
• Working knowledge of regulations, standards, paper and electronic Good Documentation Practices, and privacy/security obligations relevant to conducting IDE Trials, including 21 CFR (50, 54, 56, 812, Part 11), GCP (ISO14155:2020 and/or ICH E6 R2), HIPAA and GDPR
• Independent, reliable, professional, collaborative, team player aligned with BSC mission, vision, and culture goals
• Demonstrated experience with complex verbal and written communication to a variety of stakeholders, as well as successful conflict resolution skills
• Strong electronic system adopter/user with understanding of system user access controls and workflow validations process
• Ability to travel domestically and internationally up to 30%

Preferred Qualifications:

• RAQP-GCP/ SoCRA or ACRP certification or equivalent
• Experience with maintaining compliance to medical device manufacturer quality system or other clinical quality system requirements
• EU CA, Health Canada, PMDA, CFDA, BfArM experience
• 5 or more years of direct clinical quality (GCP) auditing experience
• Knowledge of EU MDR
• Non-English language(s) proficiency for reliable verbal and written audit related reviews and communication with EU investigational sites (Germany, Italy, Spain)
• Demonstrated experience communicating with all levels of the organization