Manager, Good Clinical Practices

Alcon • Johns Creek, GA

9d • $110,500 - $143,000 • Onsite

About The Position

The Manager, Good Clinical Practices (GCP) is part of Alcon’s Quality & Regulatory Affairs function and supports the QA Compliance Team. The role leads compliance activities, provides technical expertise, drives quality improvement projects, and manages external audits, site preparedness, and Corrective and Preventive Action (CAPA) processes. The position is onsite in Fort Worth, Texas; Durham, North Carolina; Johns Creek, Georgia; or Lake Forest, California, with domestic and international travel as required, up to 60%. Relocation and sponsorship assistance are not available.

The manager oversees projects and day-to-day operations, makes operational decisions about programs, resources, and schedules, and ensures quality management systems are implemented throughout processes and operations. The role also implements quality assurance regulations; writes, revises, reviews, and approves standard operating procedures; and performs or supports inspections and audits of processes and documents related to studies, facilities, equipment, suppliers, and vendors.

The position facilitates internal and external audits and regulatory inspections, reports quality or compliance concerns and deviations, recommends corrective and preventive actions, and leads implementation of new regulations, regulatory guidance, and international standards. The role requires consistent adherence to GxP regulations, SOPs, documentation requirements, quality controls, and required training, together with a commitment to continuous improvement.

Requirements

• Bachelor’s degree or equivalent years of directly related experience; alternatives listed are high school plus 13 years, associate degree plus 9 years, master’s degree plus 2 years, or Ph.D. plus 0 years.
• Five years of relevant experience.
• Ability to fluently read, write, understand, and communicate in English.

Nice To Haves

• Knowledge of ISO 14155, ICH E6, Medical Device EU and FDA regulatory requirements, and the Declaration of Helsinki.
• Validated GCP audit track record.
• Good analytical skills and judgment.
• Advocacy for outstanding quality and compliance standards without compromising customer expectations or regulatory requirements.

Responsibilities

• Manage individual projects, applying advanced knowledge to achieve objectives and affect project performance and operational efficiency.
• Oversee day-to-day operations, ensuring productivity and alignment with departmental objectives.
• Make operational decisions and manage programs, resources, and schedules.
• Ensure implementation of quality management systems at every stage of processes and operations.
• Implement quality assurance regulations and write, revise, review, and approve standard operating procedures.
• Perform and support inspections and audits of processes and documents associated with studies, facilities, equipment, suppliers, and vendors to ensure compliance with applicable GCP/GLP regulatory requirements, SOPs, and study protocols.
• Manage, support, and facilitate internal and external audits and regulatory inspections; ensure site preparedness and coordinate CAPA processes.
• Report potential quality and compliance issues, ineffective processes or procedures, and deviations, and recommend corrective and preventive actions.
• Lead implementation of new regulations, regulatory guidance, and international standards.
• Follow GxP regulations and SOPs, maintain accurate and complete documentation, ensure rigorous quality control, and complete required training.
• Contribute to organizational compliance and continuous improvement.

Benefits

• Health benefits.
• Life benefits.
• Retirement benefits.
• Flexible time off.
• Short-term and long-term incentive opportunities for eligible roles.
• Programs supporting health and well-being, financial security, and retirement planning.
• Focused growth and development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager