Bausch + Lomb is actively recruiting for a Quality Systems Compliance Specialist to oversee activities in Global Compliance regarding NC/CAPA. The Quality Systems Compliance Specialist will be responsible for providing expertise in helping to resolve complex compliance issues while assisting the manufacturing/distribution and regulatory offices. This position will support Global auditors and work alongside Quality Leaders.
Specific Job Duties:
Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely 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.
- Manage the Critical Action Committee (field actions) requirements and ensure sites meet these requirements.
- Program administrator for Global audits: Ensure Global audits are written correctly and submitted on time following the Global requirements and based on solid evidence that is cited correctly. Analyze data and prepares reports on the data using tools such as Qlikview. Submit the reports and ensure electronic and hard copy filing. Manage the Global audit schedule and justify postponement-works with sites to get approval. Prepares best practices from the audits and submit to the VP’s of Quality quarterly.
- Track all external audits globally and assist sites with any information needed. Develop external audit metrics and file all documentation associated with the audits. Run the Rochester War Room communicating all possible problems to the Global Compliance Leader and VP of Quality for FA and other English-speaking inspections.
- Maintain inspector profile database and perform searches to provide sites undergoing inspections with information on inspectors.
- Manage the Quarterly Compliance Meeting: Develop the agenda with Subject Matter Experts and review proposed materials, schedule two sessions each quarter with follow-up and conduct the sessions introducing the speakers.
- Technical Auditing Committee (TAC) team member assisting with development of checklists/internal audit documentation.
- Act as a SWAT team member of Global compliance and work directly with the sites in cases of serious compliance issues.
- Trend Global compliance data including internal audits and issue reports. Compare global, site and external audits per site.
- Identify opportunities to improve the Global audit process, compliance or Quality Systems.
- Serve as back-up host for Global ISO or FDA audits and run the War Room if not involved in the inspections.
- Responsible for the NC/CAPA and Critical Action Committee’s SOP’s and makes changes to improve documentation.
- Works with the training department to develop and implement training at sites to improve compliance. Prepare and present materials for new manufacturing sites and Distribution Centers in orientation program. Works with new sites to assist in NC/CAPA, Audit Module use and help meeting the B+L Quality System.
- Perform NC/CAPA and Change control stewardship for new sites or new users.
Bausch + Lomb is an equal opportunity employer.
Education: Bachelor’s degree required; Law degree (JD) would be advantageous though not required.
Experience: 1-3 years’ experience in Regulatory, Compliance or Quality within the medical device, pharmaceutical, biologic or cosmetic industry required.
- Knowledge in NC CAPA and Audit Module usage and able to provide training to new users.
- Knowledge in the following regulations both drugs and devices: SFDA, KFDA, Health Canada, US FDA, ISO 9001 and 13485, EU, MDD, Anvisa and Japan PAL. Ability to ensure our Global Quality Systems meets these requirements and able to read and understand other regulations.
- Excellent communication, interpersonal and writing skills.
- Ability to organize and prioritize work effectively.
- Ability to work with senior executive leaders.
- Above average computer skills, and experience with use of Microsoft Word, Excel and Outlook.
- Experience in a CAPA system a plus.
- Ability to review to proofread important reports and make corrections.
- Must be able to learn, Cats web-NC CAPA and Compliant modules, Qlikview modules and Change control (Kintana) software.
United States-New York-Rochester Global Eye Health Center Site