Director, Good Clinical Practices (GCP)

Alcon; Durham (NC); On-site; USD 184,000 - 238,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Alcon is seeking a Director of Good Clinical Practices (GCP) and Lifecycle Management within the Quality & Regulatory Affairs function. This role leads strategic initiatives to ensure adherence to GCP and regulatory requirements across product lifecycle management in the R&D Quality Assurance organization.

The incumbent will guide a team in developing and implementing quality and regulatory protocols for clinical trials, ensuring compliance and successful outcomes.

Qualifications

• Bachelor's Degree or Equivalent years of directly related experience.
• 10 Years of Relevant Experience
• 6 Years of Demonstrated Leadership
• Travel: 20%
• Work Location: Onsite - Fort Worth, TX
• Relocation Assistance: Authorized

Responsibilities

• Provide leadership and strategic direction to multiple teams for successful implementation of departmental plans and achievement of business objectives
• Oversee team performance, resource allocation, and project approvals while fostering a culture of excellence and compliance
• Oversee multiple teams, implementing departmental plans
• Drive and promote cross functional quality culture and ensure implementation of quality management systems at every stage of process/operations
• Make key decisions impacting significant projects and initiatives
• Implement quality plans at every stage of the Clinical Trial process and ensure compliance with quality assurance regulations
• Support audits, regulatory inspections, and all quality control aspects, reporting potential issues and leading the implementation of new regulations
• Lead performance management, drive talent development, ensure positive associate relations, enhance

Skills

Leadership

GCP leadership

Regulatory compliance

Quality Assurance

Clinical trials

Cross-functional collaboration

Education

Bachelor's Degree

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?

Role Overview

This role is part of Alcon's Quality & Regulatory Affairs function in Fort Worth, TX, 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.

Position Summary

The Director, Good Clinical Practices (GCP) and Lifecycle Management (Management Path), is primarily responsible for leading strategic initiatives to ensure adherence to Good Clinical Practices and regulations associated with product Lifecycle Management within the Research and Development Quality Assurance department.

The incumbent will guide a team in developing and implementing quality and regulatory protocols for clinical trials, ensuring compliance and successful outcomes.

Specifics include:

• Provide leadership and strategic direction to multiple teams for successful implementation of departmental plans and achievement of business objectives
• Oversee team performance, resource allocation, and project approvals while fostering a culture of excellence and compliance
• Oversee multiple teams, implementing departmental plans
• Drive and promote cross functional quality culture and ensure implementation of quality management systems at every stage of process/operations
• Make key decisions impacting significant projects and initiatives
• Implement quality plans at every stage of the Clinical Trial process and ensure compliance with quality assurance regulations
• Support audits, regulatory inspections, and all quality control aspects, reporting potential issues and leading the implementation of new regulations
• Lead performance management, drive talent development, ensure positive associate relations, enhance

What You'll Bring to Alcon:

• Bachelor's Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
• The ability to fluently read, write, understand and communicate in English
• 10 Years of Relevant Experience
• 6 Years of Demonstrated Leadership
• Travel: 20%
• Work Location: Onsite - Fort Worth, TX
• Relocation Assistance: Authorized
• Sponsorship Assistance: None

Preferred Skills / Qualifications Include

• Degree in a scientific discipline
• Experience in GXP / GCP leadership

How You Can Thrive at Alcon:

• See your career like never before with focused growth and development opportunities
• Discover your career in a fresh way through specific growth and development possibilities.
• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides 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

183,600.00 - 237,600.00

Pay Frequency

Annual

Equal Opportunity

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.