Sr. Director, Quality Leadership (QLT)

Alcon; Johns Creek (GA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Flexible time off

PTO for hourly associates

Job summary

Alcon is seeking a Sr. Director within the Quality Leadership Team to oversee a plant's total quality function and ensure compliance with SOPs and regulatory requirements. You will lead multiple QA disciplines, drive process improvements, and maintain QMS across global standards such as EU MDR, FDA QSRs, ISO 13485, and MDSAP.

The role requires extensive leadership experience, travel, and onsite work in Johns Creek, GA. Relocation is offered and sponsorship is not provided.

Qualifications

• Bachelor's degree required.
• 12 Years of Relevant Experience.
• 8 Years of Demonstrated Leadership.
• Travel: 5-10%.
• Work Location: Onsite - Johns Creek, GA.
• Relocation Assistance: Yes.
• Sponsorship Assistance: None.

Responsibilities

• Lead and direct Quality Assurance Departments (Quality Systems, Documentation Control, QA, Quality Engineering, Regulatory Affairs, Complaint Handling, Laboratory Services).
• Ensure EU MDR 2017/745 compliance and MDCG/MDD expectations where applicable.
• Provide direction on quality systems and process improvements.
• Serve as Facility Management Representative for Quality System implementation.
• Maintain compliance with FDA QSRs, ISO 13485, MDR/MDD/MDR and ISO 14000.
• Report on quality system performance and improvement needs.
• Promote regulatory and customer requirements awareness across the organization.
• Implement systems to prevent recalls and manage post-market surveillance.
• Oversee product sterility and product release processes; support product registrations.
• Manage QA Department staffing and budgeting; foster teamwork and succession planning.
• Ensure MDSAP compliance and training in GxP; maintain documentation integrity.

Skills

Leadership

Quality Assurance

Regulatory Affairs

GxP Compliance

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? 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. The Sr. Director, Quality Leadership Team (QLT) (Management Path) is primarily responsible for leading the total quality function of a plant or group of plants, ensuring compliance with quality policies, Standard Operating Procedures (SOPs), and regulations. You will ensure the quality of materials, oversee training, and implement an effective Quality Management System. As the local Management Representative and ISO Deputy, you will ensure compliance with Quality System Standards and Regulations.

• Manage and direct Quality Assurance Departments, including Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling, and Laboratory Services
• Where applicable, ensure compliance with European Union Medical Device Regulation (EU MDR) 2017/745 and meet experience requirements per Medical Device Coordination Group (MDCG) 2019-07 and EU Council Directive 93/42/EEC (MDD)
• Provide direction on quality systems and tools, focusing on process improvements
• Perform duties as Facility Management Representative to ensure effective Quality System implementation
• As applicable, maintain compliance with Food and Drug Administration (FDA) Quality System Regulations (QSRs), ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (MDR), and ISO 14000 standards
• Report on quality system performance and improvement needs
• Promote regulatory and customer requirements awareness throughout the organization
• Implement systems to prevent product recalls and manage post market surveillance actions
• Maintain responsibility for product sterility systems and product release
• Support product registration requirements as applicable
• Manage a suitably resourced Quality Assurance Department with qualified personnel
• Promote cooperation and teamwork through open communication and coordination
• Identify potential successors for key positions and develop readiness plans
• Identify future budgetary requirements and manage Quality Assurance budget within target
• Ensure Quality Management System compliance with Medical Device Single Audit Program (MDSAP) requirements and support certification efforts
• Adhere to Good Practice (GxP) regulations, maintain accurate documentation, and complete required training, (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training

What You'll Bring to Alcon

• Bachelor's Degree
• The ability to fluently read, write, understand and communicate in English
• 12 Years of Relevant Experience
• 8 Years of Demonstrated Leadership
• Travel: 5-10%
• Work Location: Onsite - Johns Creek, GA
• Relocation Assistance: Yes
• Sponsorship Assistance: None

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE

• If Designated as Responsible Person - For a pharmaceutical/aseptic plant/product, a pharmacy degree or other science-based qualifications are acceptable with 1-2 years' experience of distribution activities.
• If designated PRRC - University degree in law, medicine, pharmacy, engineering or another relevant scientific discipline plus 1 year experience in device regulatory or QMS or 4 years of regulatory affairs or quality management experience related to medical devices. Degrees acquired outside the EU will need to be recognized by an EU Member State as equivalent to the EU corresponding qualification. Professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU requirements in the field and be substantive and recent.

How you can thrive at Alcon:

• Work together with colleagues to share standard methodologies and discoveries as work progresses.
• 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 a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

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 [e-mail] let us know the nature of your request and your contact information.