Senior Quality Specialist

Bausch+Lomb Companies Inc.•Lynchburg, VA

4d•$86,000 - $130,000

About The Position

The Senior Quality Specialist develops and maintains site Quality systems to ensure compliance with FDA, ISO, country-specific regulations and standards, and Bausch + Lomb QMS requirements. The role supports local and global Quality initiatives and works with site functions to maintain regulatory compliance. The position oversees and supports a broad range of Quality system activities, including nonconformance and CAPA, change control, document and records management, data integrity, validation, risk management, training, regulated labeling reviews, customer complaints, supplier management, auditing, quality metrics, and verification of released finished goods. It also supports third-party logistics centers and distribution-level quality systems, including product record reviews and system release. The Senior Quality Specialist coordinates functional teams when critical quality issues arise, keeps senior management informed of compliance issues, and proposes action plans to resolve them. The role leads cross-functional quality and compliance improvements, supports external audits, applies continuous quality improvement methods, identifies systemic weaknesses, and independently leads failure investigations and corrective and preventive actions.

Requirements

Bachelor's degree in Science or a related field.
Minimum of 5 years of Quality experience in an FDA-regulated industry.
Strong analytical and computer skills, including Windows, Word, Excel, and PowerPoint.

Nice To Haves

Distribution Center experience.
ASQ certification such as CQA, CQE, and/or SSBB.
Experience with logistics systems for inventory control and distribution.

Responsibilities

Develop and maintain site Quality systems to ensure compliance with FDA, ISO, country-specific regulations and standards, and Bausch + Lomb QMS requirements.
Support local and global Quality initiatives and collaborate with site functions to ensure regulatory compliance.
Manage or support nonconformance/CAPA, change control, document management, records management, data integrity, validation, risk management, training, regulated labeling reviews, customer complaints, supplier management, and internal and supplier auditing.
Compile site quality and compliance metrics to support Management Oversight inputs and verify released finished goods.
Provide Quality system support to third-party logistics centers as requested.
Support development, implementation, and maintenance of efficient, effective, and compliant distribution-level quality systems, including product record reviews and system release.
Support systematic control of non-conforming material and corrections or removals where applicable.
Coordinate functional areas when a critical quality issue is discovered.
Keep senior management updated on compliance issues and propose solutions with action plans.
Lead cross-functional teams to drive compliance and quality improvements across departments and sites.
Support external audits as assigned.
Direct and coordinate Quality activities using continuous quality improvement principles and methodologies.
Identify systemic weaknesses and lead initiatives to implement corrective action where applicable.
Independently lead failure investigations using root cause analysis tools and propose and implement systematic corrective and preventive actions.