Senior Manager Quality Compliance (Rare Disease)

Responsibilities

• Serve as a GCP Subject Matter Expert for clinical trial activities
• Plan and conduct risk-based GCP audits and support outsourced audits
• Manage regulatory inspections and provide guidance on health authority responses
• Oversight using the Risk Assessment Categorization Tool (RACT) for identifying trial risks
• Support clinical program meetings to review compliance-related risks and quality trends
• Conduct new vendor evaluations and qualifications in a risk-based manner
• Implement innovative quality oversight methodologies, leveraging data analytics and technology

Qualifications

• Doctorate degree with 2 years of relevant experience in Pharma/Biotech quality, operations, or regulatory compliance
• Advanced degree preferred, specifically in a scientific discipline
• Quality Assurance Qualification/Certification is a plus
• Minimum of 7 years in biopharmaceutical industry experience with core responsibilities in quality management and risk-based quality
• Minimum of 5 years as an auditor in GCP, GLP or GPvP

Benefits

• Comprehensive employee benefits package with group medical, dental, and vision coverage
• Retirement and savings plan with generous company contributions
• Discretionary annual bonus program or sales-based incentive plan
• Stock-based long-term incentives available
• Award-winning time-off plans and flexible work models