Manager, Good Clinical Practices

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons 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 managingprogramsresourcesand schedules.
• Ensure implementation of qualitymanagement systemsat every stage ofprocess/operations.
• Implement quality assurance regulations and writerevise 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 qualitycomplianceineffective 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 YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 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 Alcons 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.

Alcon Careers:

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Compensation and Benefits

Alcons 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.

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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 and let us know the nature of your request and your contact information.