Bard (NYSE:BCR) is a $3B high-quality developer and manufacturer of life-saving medical devices. Product families include balloons used to relieve blocked veins and arteries, ports used to deliver chemo-therapy treatment, filters that prevent blood clots from traveling to the lungs and heart, urological catheters, and guidewires necessary for almost every medical device procedure. The Corporation has 26 locations and 13,000 employees world-wide.
(For more about the Corporation, please explore our website at www.crbard.com )
The Glens Falls Operation is known as Bard’s Technology Center and is Bard’s largest domestic manufacturing facility employing approximately 700 in a three shift operation. The Glens Falls Operation manufactures over 20 different product lines serving all Bard Divisions.
The Quality Compliance Manager reports to the site Quality Head with a dotted line to the site Head of Operations. She/he is responsible for the identification, implementation of continous improvement initiatives based on current and forthcoming regulatory compliance requirements associated with Regulatory Compliance and the Internal Audit Program. In addition she/he directs the local internal audit program at the facility as well provides training and guidance for the site audit team members and site management. She/he assists the Quality Head and the site Head of Operations with the planning of required internal 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 regulatory compliance and auditing issues.
1. Provides leadership and guidance in the timely communication/escalation to the Quality Head and Head of Operations of site issues associated with regulatory compliance/audits findings.
2.Maintains comprehensive knowledge of applicable regulatory requirements and their interpretation. Provides regulatory compliance expertise to the site management by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the Bard site.
3.Supports site management in the development of quarterly and annual audit metrics and summaries for distribution to key Corporate, Divisional and Manufacturing site management. Identify and communicate systemic issues to site Management for further comprehensive action.
4. She/he directs the internal auditing function and the audit team members for the implementation of regulatory and quality system effectiveness audits at the manufacturing site.. In coordination with the site Quality Head and site Head of Operations will schedule and implement plans for comprehensive annual reviews of the regulatory compliance and internal audits areas taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment.
5. Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards and other applicable requirements[i.e. QMS, QSIT, Combination Products, Regulatory requirements; PAL, TGA, Notified Bodies, etc.]
6. Provides leadership and assists as necessary in critical supplier audits.
7. Provides guidance and coaching to the team SMEs/auditors in the conduct of audits, documentation of findings, support for auditee development of the Audit Action Plans and evaluation of effectiveness checks.
8. Provides auditor training to audit team members, internal auditors and supporting auditors as assigned through formal classroom training, web based, or on-the-job training.
9. Maintains a high degree of personal professional development through a combination of internal and external training and participation in professional associations as appropriate.
10. She/he participates in the Corporate Compliance Council to drive compliance initiatives
5+ years quality, compliance and regulatory experience in the Medical Device Industry, Combination Products, Regulatory requirements and/or Pharmaceutical experience preferred.
3+ years managing Compliance/ Audit programs and conducting audits in the medical device or drug industry preferrably in a corporate function
3+ years personnel management experience.
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 is a must have (ASQ CQA, RABQSA, IRCA, EOQ) only one of the listed will satisfy the requirement.
Fully Bilingual (as applicable to local language and English)
Lean Six-Sigma Black Belt Certification
Certified Quality Engineer
Certified Quality Manager
B.S. degree in Engineering or the Physical or Biological Sciences.
May require some exposure to chemicals used in manufacturing processes. Some minor physical inconvenience or discomfort occasionally present in the work situation (moderate noise, disagreeable odors, etc.). May be subject to situations requiring precautions due to the potential for minor injury or other health hazards.
“Bard is a VEVRAA Federal Contractor and desires priority referrals of protected veterans for all openings.” For verification of information in the job listings, please contact (518) 793-2531.
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