Total 2 job vacancies by U339 Alcon Vision, LLC. Company

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Associate Director Clinical QA, you will be trusted to provide input and assist in establishing the vision and strategic direction for Clinical R&D activities in the R&D, QA, GCP, GLP and Medical Safety Operations Groups at our Main Campus in Fort Worth, TX.

POSITION PURPOSE

• Provides input and assist in establishing the vision and strategic direction for Clinical R&D activities as part of the R&D QA GCP, GLP and Medical Safety Operations Group.
• Provides Clinical QA oversight to ensure that global Clinical Operations activities conducted by Alcon for its medical devices and pharmaceutical products are in compliance with applicable regulations, guidelines and/ or quality standards.
• Manages the Good Clinical Practice (GCP) audit program across all Alcon franchises to assure clinical related activities are conducted according to Alcon and quality standards and applicable regulations with high degree independence.  

In this role, a typical day will include:

• Provides leadership and sound business ethics in the interpretation and implementation of global GxP compliance programs, computer system and/or software validation and related services and compliance training while ensuring Clinical QA independent assessments.
• Supports clinical research and development activities for all Alcon franchises and Technology Platforms to maximize standardization and compliance.
• Advises senior management of the need for corrective and preventive actions with a key advisory role in the development of action plans and monitoring of effectiveness of action plans as a result of internal and/or external Regulatory audits.
• Ensures senior management awareness of compliance issues impacting regulatory acceptability, by appropriately escalating as per quality risk management.
• Provides support to relevant functions on proper identification and escalation of quality related issues.
• Trends, interprets and presents compliance data and metrics according to worldwide legal and regulatory requirements and Alcon standards.
• Drives/facilitates projects in collaboration with stakeholders to evaluate and or implement quality/compliance improvement initiatives.
• Leads or support cross-functional teams to evaluate impact of process changes to systems and related processes, to research best practices, determine solutions and manage change.
• Develops unique approaches to promote and instill a culture of quality and compliance.
• Provides coaching, and aid in the development of RDQA Clinical staff and business partners.
• Provides consultation and education including, but not limited to interpretation of global regulations and guidelines such as GCP, US FDA EU MDR, ISO Standards, etc.
• Authors or reviews & approves documentation including but not limited to audit schedule, plans and reports, documents associated with regulatory submissions, notes to file, study protocols, document templates, plans and reports, and clinical evaluation documents.
• Leads and supports the investigation of deviations and other quality issues detected from any source e.g., monitoring and data management, trends, signals, etc. 
• Provides guidance, review, and approval of associated deviations (NCI, CAPAs and Actions) and evaluates effectiveness.
• Provides R&D QA support to Supplier Evaluation Teams, and function as Clinical SME for service providers.
• Leads audit & inspection preparation, conduct and remediation as needed, for both national and local inspections (e.g., FDA, EMA, MHRA, TUV etc.).
• Contributes to cross-divisional activities including but not limited to FAA, FSCA and/or Market Actions/ Investigational Product Field Actions as assigned.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs).
• The ability to fluently read, write, understand, and communicate in English.
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Work hours: Exempt
• Travel Requirements: up to 20% as needed.
• Relocation assistance: No
• Sponsorship available: No

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in science or technology.
• QA work experience in a regulated Medical Device / Pharmaceutical Industry.
• Strong R&D experience and knowledge, with manufacturing experience desired.
• Proven personnel management experience.
• Advanced knowledge of ISO 14155/ 14971, 13485, ICH 6, Medical Device and Pharmaceutical EU and FDA 21 CFR 820 / 211 regulatory requirements.
• Highly proficient in MS Office.
• Highly proficient in data analytics, critical thinking, and decision making.
• Proven influencing and negotiating skillset.
• Ability to lead virtual teams and function in a matrix organization, with project management experience desired.
• Advocate for exceptional Quality and Compliance Standards - does not compromise on customer expectations and regulatory requirements.

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Customs Compliance Analyst supporting the Global Trade Compliance team, o work on Alcon's import compliance activities, reducing costs, and handling risks within our Fort Worth, TX location.

In this role, a typical day will include:

• Supporting customs compliance initiatives, with a focus on customs entry operations, customs broker management, classification, valuation, trade programs and agreements, and internal auditing.
• Assisting with the development, implementation, and continuous improvement of Alcon’s global trade compliance program.
• Supporting internal customs audits and compliance reviews.
• Managing FDA-related data to ensure compliance with import declaration requirements.
• Provide analytical support for projects, new business opportunities, and proposals.

WHAT YOU'LL BRING TO ALCON:

Key Requirements/Minimum Qualifications:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
• The ability to fluently read, write, understand, and communicate in English.

Preferred Qualifications:

• Prior Customs-related experience; additional customs certifications/licenses are preferred.
• FDA regulation knowledge preferred.
• Strong data analytic skills

HOW YOU CAN THRIVE AT ALCON:

• Benefit from working in a highly collaborative, diverse, and innovative environment.
• Sharpen your current skills and gain exposure within different areas of the business.
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight and improve lives!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more!

Additional Position Information:

• Work hours: Standard hours, Hybrid schedule - Monday-Thursday onsite, Fridays from home.
• Travel Requirements: 5%
• Relocation assistance: NoSponsorship available: No

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.