Principal Quality Auditor

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.

Purpose of Job

This position will have responsibility for the Internal Audit programs for both the Greenville, SC and Tampa, FL B+L production facilities. The Principal Internal Quality Auditor will have responsibility for audit scheduling, planning, training, and support of execution and documentation of quality system audits of internal processes to assure compliance to applicable domestic and international regulations and standards and company policies and procedures.  This position will also be responsible for maintaining a library of standards and for reviewing all applicable regulations, standards and communicating requirements to site leadership.  This position will assist in providing cGMP / GXP, technical and auditing development to other QA and operations personnel through participation in the audit processes, management review, and associated training.

Key Activities

COMPLIANCE: Ensure the Quality Assurance department maintains a robust self-inspection program through Internal Audits. Ensure sites maintain compliance with medical device and pharmaceutical guidance, standards, and requirements. This will include familiarity with and adherence to domestic and international regulatory requirements as applicable for the product types and countries the product is marketed (such as but not limited to FDA, EU Annex 1, Health Canada, ANVISA, TGA, MHLW, or other applicable country specific health authorities, MDSAP, etc.) as well as standards including but not limited to ISO 13485, 21 CFR Parts 210, 211, and 820 as applicable. Assist sites with identification of potential gaps or areas of non-adherence to requirements through the Internal Audit program and provide oversight to closure.  Develop and maintain internal audit schedules.  Conduct internal audits as required to meet current regulatory and Global Quality expectations. Assist Supplier Quality Auditor, on a limited basis as needed. (May require limited domestic or international travel). Establish, maintain, and manage standards library.  Ensure periodic review of regulations / standards to include global policies and directives and provide education of those changes to site leadership to ensure compliance.  Support administration and execution of external 

(3rd party) audits on a limited basis. Communicate identified compliance risks to management. Create and maintain appropriate documentation  of all audits and inspections as required. Participate in the preparation and review of files in preparation for audits and regulatory inspections. Assist with 3rd party customer inquiries and requests and manage periodic product audits.

CONTINUOUS IMPROVEMENT: Identify, evaluate, select, and implement continuous improvement and compliance initiatives.  Create and edit procedures, policies, specifications, and other regulated documentation as needed for process improvement.

SUPERVISING, PLANNING & DIRECTING: Establish, communicate, and execute against strategic quality and site objectives.  Assist in developing internal auditors in coordination with departmental management.  Promote open communications with the department and internal customers.  Schedule and coordinate with site auditors to meet performance attainment of the audit schedule.  Provide project support as needed for key plant and global initiatives. Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.

Additional activities to support Quality System Compliance Department as needed.

Scope of Position:

Reporting directly to the Quality Systems and Compliance Manager, the Principal Quality Auditor will have responsibility for audit scheduling, planning, execution, and documentation of quality system audits of internal processes for the Greenville and Tampa locations.

This position will also be responsible for maintaining the site standards list and managing the associated standard assessment process, and for reviewing all applicable regulations, standards and communicating requirements to site leadership. 

This position will provide cGMP / GXP, technical and auditing development to other QA and operations personnel through participation in the audit processes, management review and associated training.

Minimum Qualifications:  

• BS in a scientific discipline required.
• 5 plus years of Quality Auditing and/or compliance experience in a pharmaceutical/ medical device or GMP regulated industry, including 21 CFR 210, 210/211 and or 820 regulations.
• Knowledge of auditing techniques and applicable GMP’s.
• Familiarity with EU and relevant MDSAP requirements preferred.

Preferred Qualifications:

• Experience in sterile drug products manufacturing preferred. 
• Knowledge of CQMS or similar equivalent system.
• CQA or ISO Lead Auditor certification.
   

Special Skills:

• Strong organizational and communication skills required in order to develop programs, work independently with minimal supervision and effectively interact with all levels of the organization.
• Demonstrated technical writing and proficiency with Microsoft Office Suite.

This position may be available in the following location(s): US - Greenville, SC (Plant)

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.

[IF APPLICABLE] For U.S. locations that require disclosure of compensation, the starting pay for this role is between [$000,000.00 and  $000,000.00] [or $00.00 - $00.00 per hour].  The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.

[SHOULD BE INCLUDED WITH PAY TRANSPARENCY LANGUAGE IN THE PARAGRAPH ABOVE IF APPLICABLE] 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.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch + Lomb's Job Offer Fraud Statement.

Our Benefit Programs: Employee Benefits: Bausch + Lomb

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.