Sr. Director, Quality Assurance Compliance at Alcon

Fort Worth, Texas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree
Adherence to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
Commitment to compliance with regulatory requirements and continuous improvement

Responsibilities

Develop, implement, manage, and monitor Alcon's global strategies for Corporate Quality Compliance programs and initiatives for success and sustainability, both internally and externally with Health Authorities
Ensure enterprise compliance to EU MDR 2017/745
Coach and develop direct and indirect reports through ongoing, example-based performance feedback, and provision of training and development opportunities
Strategically contribute to the development, articulation, implementation, and continuous improvement of Global Quality projects, policies, and compliance programs
Communicate critical assessments to Senior Leadership regarding the state of compliance and quality, providing insights into risks or potential concerns (business, patient safety, etc.), and drive actions to implement plans to improve compliance and quality performance
Support directing, administration, and management of Corporate Quality support for Health Authority inspections by providing onsite manufacturing strategic pre-inspection preparatory support and strategic direction during inspections
Contribute to negotiation of Alcon corrective action plans with Health Authorities (FDA, EMA, Competent Authorities, etc.) associated with inspectional observations to drive favorable results
Support directing, administration, and management of the Global Incident Management process (Escalation, Field Action Assessments, HA Reporting including US Field Alert Reporting, Market Action, Compliance Alert, Compliance/Auditing Forums)
Implement the Global Market Action / Recall Management including cross-functional risk assessment and input for global impact of internal and external notifications, product availability/replenishment, etc
Strategically contribute to external Health Authority submission management (FDA, EMA, Competent Authorities, etc.) for global statutory reporting, analysis of corrective actions, risk assessment, destruction, and statutory termination activities of market action activities
Create, implement, and maintain all Alcon Computer Systems Validation standards and processes resulting in GxP-compliant, high-quality IT solutions fit for their intended use
Drive strategic planning and operational execution for Data Integrity (DI) initiatives, including setting direction, defining priorities, and giving operational guidance to ensure alignment with standards and Health Authority regulations
Meet individual job requirements and contribute to the overall compliance of the organization

Skills

EU MDR 2017/745

Quality Compliance

Regulatory Affairs

Health Authority Inspections

Global Quality Strategies

Leadership Development

Risk Assessment

Performance Feedback

Policy Implementation

Strategic Communication

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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