Principal Quality Auditor-Global Compliance

Job Title Principal Quality Auditor-Global Compliance Req # 5356BR Job Description Experienced senior level auditor for the Global Quality Compliance audit. Will work to ensure Bausch & Lomb sites and functions maintain a compliant quality system by abiding by B&L policies and the laws/regulations of the countries in which our products are produced and marketed. Job Duties: - Responsible for leading and conducting global quality system audits (every 2 yrs. for sites, every 3 yrs. for distribution sites) - Support audits of contract manufacturers and suppliers. This includes audit planning, execution, documentation and reporting with proactive follow up with Corrective Action Procedures(CAPA). - Responsible for communication and documentation of internal and external compliance-related information. Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations. - Responsible for continuous improvement initiatives. - Inform senior management about compliance status in all areas of the business. Highlight delays, resource constraints that may adversely impact the business. - Manage global quality projects including developing and/or obtaining necessary materials. Also, lead training for quality systems. - Support external third party audits conducted in Rochester. Train and support global auditors and monitor their performance and compliance to requirements. - Responsible for conducting special investigations that are highly sensitive in nature (data integrity investigations, due diligence assessment, etc.). Qualifications - Education: Bachelors Degree (Engineering, Chemistry, Biology, Microbiology or related technical field preferred). - Experience: 8 years technical experience in a quality related function within a pharmaceutical and/or medical device environment. - Certified auditor through education and experience preferred. - Special Skills: Competency in ISO 13485: 2003/9001:2000, 21 CFR 820, 210 & 211 and Medical Device Directive desired. - Knowledgeable in FDA requirements and experience with managing agency audits. - Leadership skills, computer literate, strong written, oral communication, interpersonal skills ability to manage and prioritize multiple tasks and experience with computer programs (MS Word, Excel, PowerPoint). - Specialized Training: ISO 9000 Lead assessor certification required or ability to be certified. - ASQ Certification, CQA Certification, desirable. - Previous experience in internal/external auditing required. Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes Status Full-Time

Please refer to job code bauschandlomb-755177 when responding to this ad.

Category:	Accounting/Banking/Finance/Insurance
	> Auditing
Location:	Rochester, NY
County:	Monroe County
ZIP Code:	14602
Pay Rate:	Open
Job Terms:	full time
Company:	Bausch & Lomb
Phone:	email only please
Fax:	email only please