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 individual contributor role is responsible for management of Change Control and Data Integrity Steward for the Greenville Site.
Act as Change Review Specialist (CRS) within the global change management system (Kintana), and Data Integrity subject matter expert leading GMP data integrity program both for electronic and paper-based programs to ensure compliance with the global and regulatory requirements.
This role provides general quality system expertise in the areas of new product development, engineering studies, data integrity and validation studies.
Key Activities:
- Review and approve product artwork in D2L (Design to Launch), approve product specifications in GDMS (Documentum).
- Approve site Bill of Materials, Reconfiguration and other associated documents.
- Provide support for regulatory readiness/audits.
- Contribute to the preparation and completion of the Product Quality Reviews (PQR).
- Provide internal and external audit support.
- Manage the change control and LCB processes and meetings.
- Support regulatory and 3rd party inspections as needed.
- Provide support to CIMS for change management.
- Develop, implement, and manage Data Integrity Program.
- Identify, develop, and implement best Data Integrity Practices.
- Responsible for leading data integrity periodic reviews and performing risk monitoring of implemented systems to ensure continued compliance.
- Responsible for migration and remediation strategies when data integrity gaps are identified including associated CAPAs.
- Approve product related documentation including site master batch record documentation, BOMs, FPMs/SAMs in a timely manner.
- Review and complete Kintana requests as a CRS.
- Review QCR change plans and facilitate closures.
- Respond to external requests as needed to support the business (i.e. Private label product requests).
- Provide general quality system support in the areas of new product development, engineering studies and validation studies.
- Additional activities to support Quality System Compliance Department as needed.
Qualifications:
Education: 4-year degree or equivalent work experience required.
Specialized training in 21CFR211, 21CFR820, ISO 9001:2000, ISO 13485 preferred.
Strong analytical skills.
Ability to interact with people at all levels of the organization.
Must have the ability to manage multiple priorities and work in a fast-paced environment while still being able to make sound and timely decisions regarding product quality and impact to cost of quality.
Experience:
Minimum of 5 years’ experience in pharmaceutical/medical device industry.
Experience with automated quality systems (e.g. document management, nonconformance management, change control, etc.) preferred.
Special Skills (preferred):
Strong understanding of Pharmaceutical/Medical Device GMP, GDP and QSR.
This position may be available in the following location(s): Greenville, SC.
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.
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: https://www.bausch.com/careers/benefits/
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.
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