Director, Good Clinical Practices (GCP)

Alcon

$183K — $237K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree or equivalent experience; alternative education paths considered
  • 10 years of relevant experience in clinical quality or regulatory affairs
  • 6 years of proven leadership experience in a regulatory environment
  • Strong English communication skills, both written and verbal
  • Preferred: Degree in a scientific discipline; experience in GXP/GCP leadership

Responsibilities

  • Lead strategic initiatives ensuring compliance with Good Clinical Practices and Lifecycle Management regulations
  • Oversee multiple teams to implement departmental plans and achieve business goals
  • Manage team performance, resources, and project approvals while fostering a culture of excellence
  • Promote a cross-functional quality culture across all operations
  • Implement quality plans throughout the Clinical Trial process to ensure compliance
  • Support and lead audits, regulatory inspections, and quality control aspects
  • Drive talent development and enhance associate relations within the team

Benefits

  • Robust benefits package including health, life, and retirement options
  • Flexible time off policies to support work-life balance
  • Focus on career growth with development opportunities
  • Alignment of rewards with business objectives and long-term value
  • Support for associates through key life events and programs promoting health and well-being
Full Job Description
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. 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! Alcon Careers See your impact at alcon.com/careers ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Compensation and Benefits 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. 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

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