Global Quality & Regulatory Leadership Director

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

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.