Digital Quality & Regulatory Affairs Systems Manager

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 Digital Quality and Regulatory Affairs Systems Manager you will be trusted to serve as a systems analyst, performing business process analysis and working with Veeva to develop complex logical database designs, data models, and data definitions in support of business user requirements. Manages initiatives to maintain the validated state of the DQRA applications and ensuring data integrity is maintained. Serves as Corporate business administrator for the DQRA systems and provides consultation and training to GxP customers (end-users and super-users).

In this role sits in our Fort Worth, Texas location and a typical day will include:  

• Executes the long-term and short-term strategy of DQRA and the Veeva Vault business user communities.

• Serves as a lead for development of integrations with other systems.

• No direct management responsibility, but is highly accountable for the effectiveness, quality, and timeliness of project design decisions and effort required for design implementation.

• Ensures continuous improvement of the Veeva Vault(s), including integrations and data reporting.

• Provides user support (super-users and end-users).

• Trains users (super-users and end- users) on the use of Veeva Vault(s).

• Supports internal and external audits as DQRA Systems Manager and prepares written reports of findings and recommendations.

• Supports Veeva Vault deployments to new and acquisition sites.

• Prepares business requirement reports, feasibility studies, and cost justification statements by collecting, analyzing, and summarizing information and trends.

• Consults with client management as an expert technical resource on approaches to address business needs and opportunities in all phases of the development and implementation process.

• Supports the management and long-term strategy of system lifecycle documentation including user requirements, system specifications, and testing documentation required for computer system validation and change control.

• Provides in-depth consulting to client and IT management and staff at the highest technical level in the identification and resolution of information flow, content issues, and the transformation of business requirements into technical/functional requirements.

• Participates in the development and maintenance of corporate data architecture, data management standards and conventions, data dictionaries and data element naming standards and conventions for multiple computing environments.

• Performs data modeling studies and develops detailed data models.

• Recommends access rules in accordance with established security and privacy practices.

• Applies techniques related to scalability and data security of cloud-based data sets.

• Conducts and coordinates the system periodic user access reviews.

• Prepares / Revises SOPs / and supports lifecycle documentation in accordance with internal/parent company quality manual requirements and external regulations and standards (e.g. 21 CFR Part 11, 21 CFR 820, 210, 211, ISO/EN ISO 13485, ISO/IEC 62304, GAMP).

WHAT YOU’LL BRING TO ALCON:  

• Bachelor’s Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc. 9 yrs; M.S. 2 yrs; PhD 0 yrs)

• The ability to fluently read, write, understand, and communicate in English.

• 5 Years of Proven Experience

PREFERRED QUALIFICATIONS:  

• Veeva Vault experience

HOW YOU CAN THRIVE AT ALCON:  

• See your career like never before with focused growth and development opportunities.

• 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.

• Benefit from a highly innovative environment.

• Sharpen your current skills and gain exposure within different areas of the business.

• Join an exciting, fast paced and rewarding department!

• No Travel Requirements

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.

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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.