Manager, Good Clinical Practices

Alcon MX; Fort Worth (TX); On-site; USD 111,000 - 143,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Flexible time off

Job summary

Alcon is seeking a Manager, Good Clinical Practices (GCP) to lead compliance activities within the QA Compliance Team. The role focuses on managing external audits, ensuring site preparedness, and coordinating CAPA processes to maintain GCP/GLP regulatory standards.

It supports continuous improvement and global regulatory alignment from Fort Worth, TX, with travel as needed. Qualifications include a Bachelor’s Degree or equivalent and at least 5 years of relevant experience, with fluency in

Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
• 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% Relocation: No Sponsorship Assistance: No

Responsibilities

• Manage external audits, ensure site preparedness and coordinate CAPA processes.
• Lead compliance activities and drive quality improvement projects.
• Oversee day-to-day operations and ensure adherence to GxP regulations and SOPs.
• Implement quality assurance regulations and approve SOPs; support inspections/regulatory inspections.

Education

Bachelor’s Degree or Equivalent

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. 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 as we help people see brilliantly. 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 in Fort Worth, TX, Durham, NC, Johns Creek, GA, or Lake Forest, CA, a typical day will include: 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 that activities comply 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. All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
• 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% Relocation: No Sponsorship Assistance: No

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:

• 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

HOW YOU CAN THRIVE:

Collaborate with teammates to share standard processes and findings as work evolves. See your career like never before with focused growth and development opportunities. Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

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

Pay Range 110,500.00 - 143,000.00 Pay Frequency Annual

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.