Principal Clinical QA Specialist

Principal Clinical QA Specialist

Work mode : Hybrid

Onsite Location(s) : Arden Hills, MN, US, 55112

About the Role

The Principal Clinical QA Specialist will perform detailed clinical process and vendor audits to assure clinical research activities conform to federal and international regulations and BSC procedures. This is a global role that will audit clinical trials across all clinical divisions at BSC. Additionally, this role will work closely with clinical sourcing, clinical partnership, supplier quality, and software quality.

Your Responsibilities Will Include :

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical divisions.
• Plan and conduct audits of specific clinical processes based on risk.
• Perform clinical vendor audits along with various SMEs (e.g., software quality) to comprehensively assess all services provided by a vendor.
• Develop audit reports and distribute to appropriate stakeholders.
• Own and manage related clinical vendor non-conformances.
• Review, understand, and audit clinical related regulations and guidelines (e.g., ISO, FDA medical device regs, GCP, etc.).
• Collaborate with clinical sourcing, supplier quality, and clinical partnership to manage clinical vendors.
• Support the preparation, coordination, and participation of regulatory agency inspections of BSC offices for clinical.
• Participate and support Clinical Quality Assurance Community of Practice quality improvement projects.

Required Qualifications :

Preferred Qualifications :