Alcon

Manager, Quality Assurance Compliance

Fort Worth, Texas, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Pharmaceuticals, HealthcareIndustries

Requirements

The Manager, Quality Assurance Compliance requires experience in leading teams that manage Quality Systems, Complaints, and Supplier Quality Management processes, ensuring adherence to cGMP, Health Authority, and ISO standards. The role necessitates strong leadership, time management, communication, and team coordination skills, along with the ability to make operational decisions and foster a positive work environment. Candidates must ensure associates are well-qualified, trained, and forward-focused, with appropriate succession and development plans in place. Experience in implementing Quality Strategy, identifying process efficiencies, advising on policy, conducting training, and managing quality systems for regulatory compliance is essential. A commitment to continuous improvement and upholding regulatory requirements, including Good Practice regulations, is critical.

Responsibilities

The Manager, Quality Assurance Compliance will lead a team responsible for Quality Systems, Complaints, and Supplier Quality Management to ensure compliance with cGMP, Health Authority, and ISO standards. Responsibilities include facilitating the implementation of the Quality Strategy, supporting governance processes, and identifying opportunities for improved process efficiencies. The role involves advising on policy, conducting training sessions, managing quality systems, and ensuring associates adhere to Good Practice regulations through SOPs, accurate documentation, and training. The manager will also lead best-in-class quality practices for Distribution Centers, oversee the Business Continuity Plan, promote quality achievement, analyze data trending and productivity improvement projects, and monitor training compliance. Additionally, they will develop work instructions, maintain procedures, create training programs, enhance ways of working across multiple sites, oversee the review/approval of validation and engineering documentation, manage customer complaint handling, act as the primary point of contact for audits, coordinate documentation and interviews for auditors, support inventory requirements by ensuring timely lot disposition, and ensure compliance with Health, Safety, and Environmental standards.

Skills

Quality Assurance
Compliance
cGMP
ISO standards
Quality Systems
Complaint Management
Supplier Quality Management
Process Improvement
Regulatory Compliance
Leadership
Time Management
Communication
Team Coordination
Standard Operating Procedures (SOPs)
Documentation
Training

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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