Manager, Quality Assurance

Bausch + Lomb•US-VA-Lynchburg, NY

3d•Onsite

About The Position

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.

Requirements

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.
Experience with logistics systems for inventory control and distribution, Microsoft Windows - Word, Excel, Power Point, etc.
Strong leadership and communication/interpersonal skills.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

ASQ Certifications (CQA, CQE, and/or CMQ/QE) preferred.
Experience with SAP and/or other MRP-type systems desirable.

Responsibilities

Ensuring that the Lynchburg DC/site executes the QMS in an effective, efficient and compliant manner.
Maintaining 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.
Coordinating 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