Alcon

Sr Director, Global Quality Management Systems (QMS)

Fort Worth, Texas Full time

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 (QRA) 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 Sr. Director, Global Quality Management Systems (QMS), is primarily responsible for developing, implementing, and maintaining Quality Management Systems procedures and activities, ensuring regulatory compliance and promoting continuous improvement. You will provide strategic direction and leadership for the QMS team, collaborating with other departments to achieve objectives.

Specifics include:

  • Provide strategic leadership and supervision for harmonizing and standardizing the Quality Management System at Alcon
  • Serves as a Deputy Global ISO Management Representative
  • Interface and collaborate with sites globally and at all organizational levels
  • Maintain knowledge of industry trends, Health Authority, and Notified Body expectations/regulations, and incorporate them into business processes
  • Direct a team that establishes and maintains global QMS processes and the systems/applications that support the QRA function
  • Make significant strategic decisions to ensure a robust and fit-for-purpose QMS, including approving departmental budgets and major projects
  • Develops Subject Matter Expert (SME) networks to ensure appropriate QMS oversite and governance for sites globally
  • Provides input into Global Quality Plan and executes based on risk, regulatory framework, trends analysis and in alignment with strategic priorities for the business
  • Demonstrate leadership, strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills
  • Supports Business Development & Licensing activities where QMS input/activity is required
  • Ensure all associates adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
  • Commit to continuous improvement and compliance with regulatory requirements
  • All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting 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
  • The ability to fluently read, write, understand and communicate in English
  • 10 Years of Relevant Experience (or M.S.+7 yrs; PhD+6 yrs)
  • 8 Years of Demonstrated Leadership
  • Location: Onsite
  • Relocation Assistance: Yes

Preferred Qualifications/Skills/Experience

  • Degree in Chemistry, Pharmacy, Microbiology, Biology, Engineering or another related science

  • Professional experience in regulatory affairs or quality management experience relating medical devices (to include EU requirements)

  • Quality experience in medical device or pharmaceutical/related industry at senior level management functions.

How you can thrive at Alcon:

  • Work together with colleagues to share standard methodologies and discoveries as work progresses.
  • 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 for exempt associates, PTO for hourly associates, and much more!

Alcon Careers

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, 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.