Senior Quality Specialist

Bausch & Lomb GmbH; Lynchburg (VA); On-site; USD 86,000 - 130,000; Full time

Job summary

Bausch + Lomb is seeking a Senior Quality Specialist to develop and maintain site Quality systems ensuring FDA, ISO, and country-specific compliance, and alignment with Bausch + Lomb QMS requirements. You will support local and global quality initiatives and collaborate with site functions to ensure regulatory compliance.

The role involves leading continuous quality improvement projects, coordinating internal audits, and directing corrective actions.

Qualifications

• Bachelor's degree in Science or related field.
• Minimum 5 years experience in Quality in an FDA regulated industry.
• ASQ certification (CQA, CQE, and/or SSBB) desirable.
• Experience with logistics systems for inventory control and distribution a plus.
• Strong analytical and computer skills to include Windows, Word, Excel, Power Point, etc.

Responsibilities

• Nonconformance/CAPA, Change Control, Document Management, Records Management, Data Integrity, Validation, Risk Management, Training, Regulated Labeling Maintenance reviews, Customer Complaints, Supplier Management, Auditing (internal/supplier).
• Compilation of site quality/compliance metrics to support Management Oversight inputs.
• Quality system support for logistics centers as requested.
• Development, implementation, and maintenance of quality system at distribution level supporting product record reviews/system release.
• Systematic control of non-conforming material and corrections/removals where applicable.
• Coordinate activities of various functional areas for critical quality issues.
• Keep senior management updated on compliance issues and propose action plans.
• Lead cross-functional teams to drive compliance and quality improvements.
• Support external audits as assigned.
• Provide direction using continuous quality improvement principles.
• Identify systemic weaknesses and lead corrective actions; perform root cause analysis.

Skills

Quality assurance

Analytical skills

Windows/Office

FDA regulations

Education

Bachelor's degree in Science

ASQ certification (CQA, CQE, SSBB) desirable

Tools

Logistics software

Job description

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Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Senior Quality Specialist is responsible for the development, and maintenance of the site Quality systems to assure compliance with FDA, ISO, Country specific regulations and standards and Bausch + Lomb QMS requirements.

This individual will support Quality initiatives at both the local and global levels as well as interact with site functions to assure compliance with regulatory requirements.

Key Responsibilities

• Nonconformance/CAPA, Change Control, Document Management, department Records Management, Data Integrity, Validation, Risk Management, Training, Regulated Labeling Maintenance reviews, Customer Complaints, Supplier Management, Auditing (internal/supplier), compilation of site quality/ compliance metrics to support Management Oversight inputs, and verification of released finished goods.
• Quality system support for various third‑party logistics centers as requested.
• Support the development, implementation, and maintenance of efficient, effective, and compliant quality system at the distribution level supporting product record reviews/system release.
• Support the systematic control of non-conforming material and corrections/removals where applicable.
• Coordinates activities of the various functional areas whenever a critical quality issue is discovered.
• Keeps senior management updated on all compliance issues that occur and proposes solutions with action plans to resolve.
• Leads cross functional teams to drive compliance and quality improvements across departments and sites.
• Supports external audits as assigned.
• Provides direction and coordination of quality activities utilizing continuous quality improvement principles and methodologies.
• Identifies area of systemic weakness and leads initiatives to implement corrective action where applicable. Independently leads failure investigations, using root cause analysis tools, and proposing, implementing systematic corrective and preventive actions.

Qualifications

• Bachelor's degree in Science or related field.
• Minimum 5 yearsexperience in Quality in an FDA regulated industry.
• ASQ certification (CQA, CQE, and/or SSBB) desirable.
• Experience with logistics systems for inventory control and distribution a plus.
• Strong analytical and computer skills to include Windows, Word, Excel, Power Point, etc.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $86,000.00 and $130,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.

• 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.

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.