Senior Manager, Clinical Quality Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the quality lead for designated clinical studies and programs, offering guidance on GCP compliance and quality standards.

• Direct and support the Study Risk Assessment (SRA) process while actively participating in inspection readiness initiatives.

• Execute and oversee investigations, root cause analyses, as well as the formulation and management of CAPAs and Effectiveness Checks.

• Collaborate with stakeholders to assess and escalate quality risks, contributing to the creation of mitigation strategies.

• Work alongside internal and external teams to guarantee proper documentation, risk management, and planning for audits/inspections.

• Assist in audit planning and preparation for regulatory inspections, playing a key role in inspection management strategies and coordination.

• Engage in cross-functional and process improvement projects to enhance the effectiveness of quality systems across RD&M.

• Evaluate and authorize controlled documents, CAPAs, and SOPs to ensure alignment with quality standards and regulatory mandates.

⛳️ Requirements

• A Bachelor’s degree is mandatory.

• At least 5 years of experience in clinical research, clinical quality, or clinical compliance is required.

• Strong knowledge of GCP and global clinical trial regulations (e.g., ICH, CFR, EU Clinical Trial Regulation) is essential.

• Experience in GCP Quality is required.

• Experience with GCP inspections is necessary.

• Practical experience in supporting regulatory inspections and audits.

• Demonstrated ability in conducting investigations and managing CAPAs.

• Familiarity with clinical trial systems, quality metrics, and risk management is preferred.

• Exceptional facilitation, communication, and decision-making abilities.

• Capability to manage multiple priorities and influence stakeholders across functions.

🏝️ Benefits

• Medical, Dental, Vision, & Life insurances

• Fitness & Wellness programs including a fitness reimbursement

• Short- and Long-Term Disability insurance

• A minimum of 15 days of paid vacation and additional time off during the end-of-year shutdown (Dec 26-Dec 31)

• Up to 12 company-paid holidays plus 3 paid days off for Personal Significance

• 80 hours of sick time per calendar year

• Paid Maternity and Parental Leave benefit

• Participation in a 401(k) program with company-matched contributions

• Employee stock purchase plan

• Tuition reimbursement of up to $10,000 per calendar year

• Opportunity to participate in Employee Resource Groups