Responsibilities
- Lead and support quality assurance efforts to ensure compliance with internal policies, ICH-GCP guidelines, FDA regulations, and applicable federal and local laws.
- Help develop, implement, and maintain standard operating procedures and controlled documents for research quality and associated departments.
- Support the deployment of risk-based quality management frameworks and monitoring tools to evaluate compliance and operational performance.
- Conduct training sessions on quality assurance programs, regulatory requirements, and industry best practices.
- Promote a work environment committed to continuous quality improvement, patient safety, and accurate data reporting.
- Provide oversight and leadership for document control and change management systems to ensure integrity and traceability.
- Manage quality processes in clinical research to maintain adherence to SOPs, regulatory standards, and ethical guidelines.
- Act as a primary point of contact and subject matter expert for resolving quality-related issues and investigations internally and externally.
- Support readiness for external audits, regulatory inspections, and quality review activities.
- Facilitate communication with sponsors and regulatory bodies as required.
- Assist in preparing for inspections and maintaining up-to-date compliance records.
- Perform additional tasks as needed.
Benefits
- Comprehensive total rewards program supporting physical, mental, and financial health.
- Competitive pay structure based on performance, experience, skills, market data, and geographic location.
- Opportunities for annual bonuses or long-term incentives in addition to base salary.
Compensation
Base pay plus potential for annual bonus or long-term incentive opportunities
Work Arrangement
Remote
Other
- Relocation assistance is not provided.
- Visa sponsorship is not offered.
- McKesson Talent Advisors do not contact candidates through public chatrooms or personal email domains such as Gmail or Hotmail.
- Official job listings are published exclusively on careers.mckesson.com.
- The organization is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.
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