This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. EST Hours are required.

GENERAL POSITION SUMMARY:The Senior Manager, Compliance & Quality Assurance, R&DQA oversees compliance activities and quality issue management processes. This role leads the handling of quality events, ensuring thorough investigations and the implementation of corrective and preventive actions (CAPAs). The position collaborates closely with cross-functional teams and supports the continuous improvement of quality systems.

RESPONSIBILITIES:

• Manage quality events and deviations, including investigations, CAPAs, root cause analyses, and effectiveness checks.

• Perform initial assessment of event criticality in collaboration with quality and operational leads.

• Escalate significant findings to senior quality leadership and track key quality metrics.

• Use appropriate quality tools to document and manage investigations and continuous improvement efforts.

• Support or oversee triage and coordination of quality events, ensuring timely resolution.

• Create and manage records in electronic quality systems (e.g., Veeva or similar platforms).

• Maintain clear and proactive communication with internal teams and external stakeholders.

• Work closely with quality leads, program teams, and study/project team members.

• Contribute to risk assessment documentation and participate in risk governance activities.

• Generate and present metrics, dashboards, and reports as needed.

• Participate in inspection readiness initiatives and contribute during audits or inspections.

• Identify and support process improvement opportunities within the quality framework.

• Ensure organized documentation and easy retrieval of records and reports.

• Assist with onboarding and training of new team members.

• Support additional quality assurance activities and initiatives as required.

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES:

• Proven experience leading quality event investigations, root cause analysis, and CAPA processes.

• Familiarity with compliance standards (e.g., GxP, GCP) and industry best practices.

• Strong organizational and planning skills.

• Excellent communication, critical thinking, and problem-solving abilities.

• Ability to work independently and manage multiple priorities.

• Experience with quality management systems or tools (e.g., Veeva, TrackWise, etc.) is a plus.

PREFERRED EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a scientific, technical, or related field.

• Minimum of 6 years of relevant experience in quality assurance, compliance, or a related discipline.