The Operations Manager Quality Compliance and Audits 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 continuous 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 manages the quality support functions MRR's, CAPA's, Document control and provides updates and trending to the head of quality. 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.
Essential Job Functions:
- Provides leadership and guidance in the timely communication/escalation to the Head of Quality and Head of Operations of site issues associated with regulatory compliance/audits findings.
- 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 GFO site.
- 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.
- Manages the quality system support functions such as MRR's, CAPA's, and document control in a timely manner in order to ensure the compliance of the site.
- 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 Head of Quality 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.
- 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.].
- Provides leadership and assists as necessary in critical supplier audits.
- 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.
- 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 a high degree of personal professional development through a combination of internal and external training and participation in professional associations as appropriate.
- She/he participates in the Corporate Compliance Council to drive compliance initiatives.
- Perform other duties as assigned.
- B.S. Degree in Engineering or the Physical or Biological Sciences.
- 3+ years’ experience managing Compliance/ Audit programs and conducting audits in the medical device or drug industry preferably in a corporate function.
- 3+ years’ experience personnel management experience.
- 5+ years’ experience in Quality Compliance and Regulatory in the Medical Device Industry or Combination Products. Some pharmaceutical experience preferred.
- Certified Quality Auditor designation is a must have and at least one of the following will satisfy the requirement: ASQ CQA, RABQSA, IRCA, or EOQ.
- 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, system design methodologies, tools to investigate and determine root cause, and 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.
- Lean Six-Sigma Black Belt Certification.
- Certified Quality Engineer.
- Certified Quality Manager.
- Occasionally requires light physical effort as in periods of prolonged standing, sitting at files or worktables, bending, stooping or reaching and/or occasional lifting of light items (e.g. up to 30 lbs). Requires heavy exposure to chemicals used in manufacturing processes.
- Incumbent must be physically able to travel domestically and internationally 10-20%.
Some minor physical inconvenience or discomfort occasionally present in the work situation (moderate noise, disagreeable odors, etc.), OR frequent exposure to minor injury or other health hazard requiring some precaution
Primary Work Location USA NY - Glens Falls
Work Shift US BD 1st Shift 830am-5pm (United States of America)