Manager, Good Clinical Practices

Alcon; Durham (NC); 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 to lead GCP compliance activities within the QA Compliance Team. The role focuses on audits, CAPA coordination, and driving quality improvements across sites in Fort Worth, Durham, Johns Creek, and Lake Forest.

The ideal candidate brings extensive GCP knowledge, SOP discipline, and a proven audit track record in regulatory environments. Onsite work and travel up to 60% are required, with competitive compensation and benefits.

Qualifications

• Fluent in English reading/writing/comprehension.
• Minimum 5 years relevant experience in GCP/QA compliance.
• Knowledge of GxP regulations and SOPs.

Responsibilities

• Lead compliance activities and drive quality improvement projects.
• Manage external audits and CAPA processes.
• Coordinate inspections and ensure site preparedness for audits.

Skills

Fluent English

Education

Bachelor's Degree or Equivalent

5 Years of Relevant Experience

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. Are you ready to join us?

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 achieveobjectivesand impact project performance and operational efficiency.
• Oversee day-to-day operations, ensuring productivity and alignment with departmental objectives.
• Make operational decisions, managingprograms,resources,and schedules.
• Ensure implementation of qualitymanagement systemsat every stage ofprocess/operations.
• Implement quality assurance regulations and write,revise, review and approvestandard operating procedures.
• Performand supportinspections/audits of processes and documents associated with studies/facilities/ equipment/suppliers/vendorsto ensure that activitiescomplywithapplicableGCP/GLPregulatoryrequirements, standard operating procedures, and study protocols.
• Manage, support, andfacilitateinternal and external audits/regulatoryinspections, ensure site preparedness, and coordinate Corrective and Preventive Action (CAPA) processes.
• Report potential issues with quality,compliance,ineffective processes/procedures, and deviations and recommendappropriate corrective& preventiveactions.
• Lead implementation of new regulations, regulatory guidance, and international standards.
• Ensureadherenceto Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs),maintainingaccuratedocumentation, ensuring rigorous quality, and completing required training.
• Commitment to continuous improvement and compliance with regulatory requirements.

All associates must adhere toGxPregulations by strictly following Standard Operating Procedures (SOPs),maintainingaccurateand complete documentation, ensuring rigorous quality control, and completing all required training. Associatesare responsible formeeting 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.

Compensation and Benefits

Alcon's Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver longterm value. Our compensation approach includes a combination of fixed and variable pay, with shortterm and longterm incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and wellbeing, provide financial security, and support retirement planning.

The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.

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.