Sr. Director, Quality Leadership (QLT)

Alcon MX; Johns Creek, Northern (GA, KY); Hybrid; USD 190,000 - 270,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible time off

Relocation assistance

Job summary

Alcon is seeking a Sr. Director, Quality Leadership Team (QLT) to lead the total quality function for a plant or group of plants. You will direct Quality Assurance, Regulatory Affairs and related departments to ensure compliance with QSRs, GMPs and global standards.

As the local Management Representative and ISO Deputy, you will drive quality improvements, risk management and post-market surveillance while aligning with business goals. Johns Creek, GA onsite.

Qualifications

• Bachelor’s degree required; advanced degrees welcomed.
• Minimum 12 years of relevant industry experience with leadership responsibilities.
• Proven track record in quality systems, regulatory affairs and GMP/GxP compliance.

Responsibilities

• Lead and direct Quality Assurance Departments across QA, Regulatory, Training and related functions.
• Ensure compliance with FDA QSRs, ISO 13485, MDR/MDD and EU MDR where applicable.
• Oversee quality management systems, post-market surveillance and supplier quality.
• Report quality performance, drive process improvements and regulatory readiness.
• Develop succession plans and manage the QA department budget.

Skills

Leadership

Quality Systems

Regulatory Affairs

GxP Compliance

Documentation Control

Education

Bachelor's Degree

Tools

QMS

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. Specifics Include:* 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!