Manager, Good Clinical Practices

About the role

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality. The Manager, Good Clinical Practices (GCP) is primarily responsible for leading compliance activities, providing technical expertise, and driving quality improvement projects. You will manage external audits, ensure site preparedness, and coordinate Corrective and Preventive Action (CAPA) processes.

As a Manager, Good Clinical Practices supporting the QA Compliance Team, you may be located in Fort Worth, TX, Durham, NC, Johns Creek, GA, or Lake Forest, CA.

Responsibilities

• Manage individual projects, applying advanced knowledge to achieve objectives and impact project performance and operational efficiency.
• Oversee day-to-day operations, ensuring productivity and alignment with departmental objectives.
• Make operational decisions, managing programs, resources, and schedules.
• Ensure implementation of quality management systems at every stage of process/operations.
• Implement quality assurance regulations and write, revise, review, and approve standard operating procedures.
• Perform and support inspections/audits of processes and documents associated with studies/facilities/equipment/suppliers/vendors to ensure compliance with applicable GCP/GLP regulatory requirements, standard operating procedures, and study protocols.
• Manage, support, and facilitate internal and external audits/regulatory inspections, ensure site preparedness, and coordinate Corrective and Preventive Action (CAPA) processes.
• Report potential issues with quality, compliance, ineffective processes/procedures, and deviations and recommend appropriate corrective & preventive actions.
• Lead implementation of new regulations, regulatory guidance, and international standards.
• Ensure adherence to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring rigorous quality, and completing required training.
• Commitment to continuous improvement and compliance with regulatory requirements.

Requirements

• Bachelor’s Degree or equivalent years of directly related experience (or high school +13 years; Associate’s +9 years; Master’s +2 years; PhD +0 years).
• The ability to fluently read, write, understand, and communicate in English.
• 5 years of relevant experience.
• Work location: Onsite.
• Travel: Domestic and international as required, up to 60%.

Preferred Qualifications

• Knowledge of ISO 14155, ICH E6, Medical Device EU, FDA regulatory requirements, and Declaration of Helsinki.
• Validated GCP audit track record.
• Good analytical skills and judgment.
• Advocate for outstanding quality and compliance standards – does not compromise on customer expectations and regulatory requirements.

Benefits

Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more.

Pay

The salary range for this role is $110,500.00 - $143,000.00 annually. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.