Alcon
Manager, Good Clinical Practices
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About Alcon
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?
Role Overview
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.
Key Responsibilities
As a Manager, Good Clinical Practices (GCP) 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.
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Requirements
- 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
- 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!
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Compensation and Benefits
Alcon provides a robust benefits package including health, life, retirement, flexible time off and much more.
Total Rewards
Alcon’s Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver long-term value. Our compensation approach includes a combination of fixed and variable pay, with short-term and long-term 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 well-being, provide financial security, and support retirement planning.
Pay Range
110,500.00 - 143,000.00
Pay Frequency
Annual
Equal Opportunity Employer
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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
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