Purpose of Job:Responsible for the management of the Quality function and execution of activities at the Lynchburg Distribution Center which is responsible for receipt, storage and distribution of contact lenses, inclusive of review/release of fit sets.
Responsible to develop, establish, execute, maintain the Quality Management System to assure compliance applicable regulations, standards, inclusive of US FDA, ISO, Country specific and Bausch + Lomb requirements for the scope of the products and processes managed by the Lynchburg facility.
Key Responsibilities:- Responsible for ensuring that the Lynchburg DC/site executes the QMS in an effective, efficient and compliant manner.
- Maintains compliance with the Bausch + Lomb Quality program, and all relevant regulations (domestic and international) with which the sites must comply.
- Supervision/management responsibility for assigned Quality staff for Lynchburg DC.
- Responsible for the documentation, change control, non-conformance/CAPA, training, internal auditing, management review, supplier quality, incoming receiving/inspection, validation, and complaint handling at the Lynchburg DC to ensure proper execution, review and approval by the Quality unit.
- Coordinates activities of the various functional areas whenever a critical quality issue is discovered.
- Maintenance and reporting of Quality metrics to senior management/ updates on all major compliance issues and propose action plans to resolve.
- Provides direction and coordination of quality actives utilizing continuous quality improvement principles and methodologies.
- Development and execution of annual Site Quality Plans and management reviews.
- Ensure timely planning and execution of internal audits and remain audit ready for external audits of the Quality Management System.
- Education of all LYN site functions regarding company Quality objectives and goals, Quality Policy, and Quality improvements.
- Other duties as assigned
Qualifications:- BS in Engineering or applicable scientific discipline
- Minimum of 5 years in the FDA-regulated industry including at least 3 years in the pharmaceutical/medical device field, preferably in the distribution space. 3 to 5 years leading people.
- ASQ Certifications (CQA, CQE, and/or CMQ/QE) preferred.
- Technology skills: Experience with logistics systems for inventory control and distribution, Microsoft Windows - Word, Excel, Power Point, etc. Experience with SAP and/or other MRP-type systems desirable.
- Strong leadership and communication/interpersonal skills.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
