Director, QA Operations
AlconAbout the role
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, versatile individuals to join Alcon. As the DIRECTOR , QA OPERATIONS, support the QUALITY ASSURANCE FAMILY, you will be responsible for Manufacturing Quality Assurance work which includes defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product at the ASPEX FACILITY in FORT WORTH, TX.
In this role, a typical day will include:
Direct and monitor business activities to ensure alignment with business plan.
Provide oversight to ensure that all marketed products are manufactured to appropriate cGMP standards including review and approval of specific procedures and master batch records, approval of specifications and critical process parameters, discrepancy investigations, and batch release.
Responsible for status decisions on product and resolution of quality issues related to manufacturing, sterilization, labeling and packaging of semi processed materials and finished products.
Oversee online Quality Assurance inspection/Quality Engineering activities of applicable production lines, returned goods operations, data trending and productivity improvement projects.
Oversee the review/approval of Validation and engineering documentation and change control.
Manage the customer complaint handling and reporting activities.
Support inventory requirements by ensuring that staff members adhere to standard lead times for the completion of all lot disposition activities.
Perform review of discrepancies, investigation, EC assay variances, and anomalous results associated with batch history records to evaluate cumulative effect prior to product disposition; Clearly demonstrating independent judgment in making decision for marketed product release based upon knowledge of regulatory requirements, industry standards, and company strategy.
Provide a safe working environment for associates, contractors, and visitors.
Ensure compliance with Health Safety and Environmental standards at all levels of the organization and facilities are audit ready.
Strategy and Direction Setting: Develop strategies and provide direction for the growth of the organization Functions as final Manufacturing QA plant authority.
Create a positive work environment that enables all associates to perform at their best.
Ensure the organization has appropriate succession and associate development plans.
Ensure organization is staffed with well qualified, trained, and forward focused individuals.
Coordinate proactively with other facilities and division functions to assure appropriate levels of involvement, guidance, and direction.
What you'll bring to Alcon:
Bachelor’s Degree or equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
The ability to fluently read, write, understand, and communicate in English
10 years of relevant experience
6 years of demonstrated leadership
Work Hours – Monday through Friday, 8:00am – 5:00pm (with flexibility depending on business needs)
Travel: 0 to 10%
Relocation assistance: Yes
Sponsorship: No
How you can thrive at Alcon:
Collaborate with teammates to share standard processes and findings as work evolves!
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 a robust benefits package, including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!
Alcon Careers
See your impact at alcon.com.careers
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