Not Specified years
Posted 97 days ago
This position is responsible for assisting the Vice President of Quality Systems Compliance in directing and conducting Quality Management System (QMS) and Product Quality / Shokiryudo assessments at Terumo facilities that manufacture products for the
US market to confirm compliance with applicable US & international regulations / standards (such as 21 CFR (including Parts 7, 11, 211, 801, 803, 806, & 820); Canadian MDR; Japanese Ministerial Ordinances; ISO 13485; the Medical Device Directive; & EU-MDR). This position is, also, responsible to assist with
reporting the results of such assessments to the management staff at the local facility for purposes of determining the appropriate corrective actions that may be necessary to bring the QMS &/or production processes into substantial compliance with applicable US & international regulations / standards. In addition, this
position is responsible to facilitate communication with Terumo affiliates, as well as assist with reporting the individual & aggregate assessment results to Terumo Corporation (TC) management for awareness of the relative regulatory compliance risks, which could result in some sort of regulatory enforcement action.
This position is responsible for properly completing all assigned corporate assessment activities & assisting to assure that management is effectively informed of requirements that are necessary to establish / maintain compliance with applicable US & international regulations / standards. Maintaining regulatory compliance is important because failure to do so can result in remedial actions ranging from internal QMS corrective actions, to product recall from the market, to litigation, &/or regulatory action by the FDA to address the situation. This position is responsible for activities that may affect the operation of a single Terumo facility, or the entire corporation, with regards to addressing issues with a Notified Body, the FDA, or other regulatory agencies. When appropriate, this position may assist with directing changes in company policy to ensure product safety, product effectiveness, ethical behavior &/or compliance with applicable regulations.
1. Maintain training and follow applicable quality system procedures.
2. Maintain up-to-date knowledge of applicable national / international QMS/GMP regulations, standards, guidelines and regulated industry trends.
3. Investigate, audit, analyze, propose improvements and direct the assigned Quality Management System activities.
4. Assist to establish, organize, monitor, & obtain agreement on the annual QAD / CQO Staff Quality Management System (QMS) & Product Quality Assessment Program in coordination with QAD / CQO Staff in Japan, as well as Quality Management staff at various Terumo facilities.
5. Assist to direct & conduct Product Quality / Shoki-Ryudo & QMS assessments of Terumo facilities that manufacture products distributed in the US.
a. Assessments will include supervision of global audit team resources, & collaboration with consultant support, when deemed appropriate.
6. Provide Quality Management System (QMS) assistance for Terumo facilities including:
a. Review of QMS improvement & corrective action plans proposed to address identified compliance risks;
b. Advice & support for various interactions with regulatory authorities;
c. Facilitate / optimize the growth of Terumo global human resources expertise in US Federal Regulation compliance through QMS training & development of Terumo associates on a global basis, including both US & OUS affiliates.
7. Participate in the evaluation of QMS compliance risks based on on-site observation / assessment of QMS practices, review of audit results, review of periodic Quality Reports, & preparation of periodic summary reports to Terumo senior management.
8. Assist in the facilitation of communications with Terumo group affiliates such as:
a. Sharing of QMS best practices & lessons learned;
b. Immediate & Periodic Quality Reporting information;
c. Effective QSR/FDA/cGMP training programs;
d. Computer-based QMS compliance tools;
e. Other communications, as deemed appropriate.
9. Support the improvement of procedures & processes to enhance corporate integrity, encourage ethical behavior, optimize QMS practices / product quality, & minimize Terumo’s regulatory compliance risks.
10. Interact with industry organizations, regulators & colleagues to remain up-to-date with the ever-changing demands within the QMS regulatory compliance & enforcement environment.
11. When requested, provide assistance with regards to compliance of other regulated processes including occupational safety, environmental protection, labor laws, transportation regulations, Sales/Marketing activities, etc.
12. Performs other job-related duties as assigned.
Internal Contacts: Senior management members throughout the Terumo Group, TAH, & at individual Terumo affiliates, including, but not limited to, the following: Presidents, CEOs, Vice Presidents, CFOs, CIOs, Directors, Management staff & associates in HR, Quality, Regulatory Affairs, Clinical Affairs, Facilities Engineering, Development & Technology Engineering, Materials Management, Production, Sterilization & Logistics.