Summary of Position with General Responsibilities
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.
Essential Job Functions
- Provides leadership to the Bard site in the areas Regulatory Compliance and the Audit Program. In addition provides guidance to the local audit team members for the implementation of regulatory and quality system effectiveness audits of Bard plants and suppliers.
- In coordination with the site Head of Quality and Plant Management will schedule and implement plans for comprehensive annual regulatory compliance and internal audits taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment.
- Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards..[i.e. QMS , QSIT, Combination Products, Regulatory requirements; PAL, TGA, Notified Bodies, etc.]
- Provides guidance and coaching to the compliance team auditors in the conduct of audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks.
- Supports 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 Management for further comprehensive action.
- 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.
- Maintains comprehensive knowledge of applicable regulatory authority quality and regulatory requirements and their interpretation. Provides regulatory compliance expertise to the site by sharing external regulatory environment and industry trends.
- Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
- Participate in the Corporate Compliance Council to drive compliance initiatives
- Provides leadership and assists as necessary in critical supplier audits.
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)
Additional Desirable Qualifications Skills and Knowledge
Certified Quality Engineer
Certified Quality Manager
Education and/or Experience
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%)
Job ID 2017-10638