Senior Quality Systems Lead – FDA-Regulated

Bausch + Lomb; Lynchburg (VA); Sur place; USD 86 000 - 130 000; Plein temps

Avantages offerts par ce poste

Medical insurance

401(k) plan

Tuition reimbursement

Paid time off

Résumé du poste

Bausch + Lomb is seeking a Senior Quality Specialist in the United States to develop and maintain site Quality systems ensuring FDA, ISO, and country-specific regulations compliance. You will support regulatory requirements at local and global levels and interact with site functions.

Key responsibilities include CAPA, change control, document management, data integrity, risk management, and leading cross-functional teams to improve quality and compliance across the organization. U.S.

Qualifications

• Bachelor's degree in Science or related field.
• Minimum 5 years experience in Quality in an FDA regulated industry.
• ASQ certification desirable.

Responsabilités

• Nonconformance/CAPA, Change Control, Document Management, Data Integrity, Validation, Risk Management, Training, Regulated Labeling, Customer Complaints, Supplier Management, Auditing, metrics reporting.
• Support quality systems at distribution centers and sites to ensure compliance.
• Lead cross-functional teams to drive quality improvements and corrective actions.
• Coordinate external audits and implement continuous quality improvement initiatives.

Description du poste

Bausch + Lomb is seeking a Senior Quality Specialist in the United States to develop and maintain site Quality systems ensuring FDA, ISO, and country-specific regulations compliance. You will support regulatory requirements at local and global levels and interact with site functions.

Key responsibilities include CAPA, change control, document management, data integrity, risk management, and leading cross-functional teams to improve quality and compliance across the organization. U.S.