The Operations Manager Quality Compliance and Audits, is responsible for the implementation and continuous improvement of the Bard site Regulatory Compliance and the Audit Program. In this role, she/he is responsible for the identifying and implementing quality and regulatory compliance initiatives based on current and forthcoming regulatory compliance requirements as well oversees the local internal audit program at Bard facilities, products, manufacturing processes and providing training and guidance for the site audit team members and site management. She/he assists the Head of Quality and Plant Site Management with the planning of required annual audits and other audits as needed and assigned. She/he conducts training and coaching of the local audit team members on the how to conduct audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks as well review / evaluate adequate completion of all planned actions via supporting documentation. She/he monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to site manufacturing facilities management during management reviews. She/he functions as a subject matter expert for quality and regulatory compliance issues.
Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals and combination products.
Demonstrated ability to direct and provide advice on the use of process excellence and system design methodologies and tools to investigate and determine root cause, assess compliance risk and establish comprehensive and effective actions plans.
Effective project management, communication and organizational skills are essential.
Demonstrated ability to effectively collaborate and partner with all levels of management in corporate and division level sites while maintaining an appropriate assertive style is critical.
Certified Quality Auditor (ASQ CQA, RABQSA, IRCA, EOQ) only one of the listed will satisfy the requirement.
Fully Bilingual (as applicable to local language and English)
Certified Quality Engineer
Certified Quality Manager
B.S. degree in Engineering or the Physical or Biological Sciences.
5+ years of quality, compliance and regulatory experience in the medical device industry. Combination product, Regulatory requirements and/or pharmaceutical experience preferred.
3+ years managing an audit program and conducting audits in the medical device or drug industry preferably in a corporate function
3+ years of personnel management experience
Incumbent must be physically able to travel domestically and internationally (Travel is 20-30%)