Sr Director, Global Quality Management Systems (QMS) at Alcon

Fort Worth, Texas, United States

Alcon Logo
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
  • The ability to fluently read, write, understand and communicate in English
  • 10 Years of Relevant Experience (or M.S.+7 yrs; PhD+6 yrs)
  • 8 Years of Demonstrated Leadership
  • Location: Onsite
  • Preferred Qualifications/Skills/Experience
  • Degree in Chemistry, Pharmacy, Microbiology, Biology, Engineering or another related science
  • Professional experience in regulatory affairs or quality management relating to medical devices (to include EU requirements)
  • Quality experience in medical device or pharmaceutical/related industry at senior level management functions

Responsibilities

  • Provide strategic leadership and supervision for harmonizing and standardizing the Quality Management System at Alcon
  • Serve as a Deputy Global ISO Management Representative
  • Interface and collaborate with sites globally and at all organizational levels
  • Maintain knowledge of industry trends, Health Authority, and Notified Body expectations/regulations, and incorporate them into business processes
  • Direct a team that establishes and maintains global QMS processes and the systems/applications that support the QRA function
  • Make significant strategic decisions to ensure a robust and fit-for-purpose QMS, including approving departmental budgets and major projects
  • Develop Subject Matter Expert (SME) networks to ensure appropriate QMS oversight and governance for sites globally
  • Provide input into Global Quality Plan and execute based on risk, regulatory framework, trends analysis and in alignment with strategic priorities for the business
  • Demonstrate leadership, strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills
  • Support Business Development & Licensing activities where QMS input/activity is required
  • Ensure all associates adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
  • Commit to continuous improvement and compliance with regulatory requirements

Skills

Quality Management Systems
QMS
ISO
Regulatory Compliance
Global Quality
Strategic Leadership
Process Harmonization
Risk Management
Governance
Budget Management

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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