Pharmacovigilance (PV) Audit Manager (P/T Consultant)

Entrepreneurial
Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

A need has arisen for a dynamic individual to join our QA team as a part-time consultant to deliver assurance of quality throughout MTDA. The selected Consultant will assist the Senior Director of QA, MTDA in the ongoing delivery of an integrated, coordinated and robust PV QA program. Duties will touch upon all aspects related to the development and maintenance of an MTDA Quality system, including: SOPs, audits, inspection preparation, QA metrics, regulatory intelligence, process mapping, computer validation, etc. The consultant will also work
collaboratively with the Manager of QA, MTDA to provide day-to-day assurance of:

• Protection
of Subjects

• Veracity
of Data

• Legal
Protection of Company

This fixed-term 12-month consulting assignment offers a flexible 4-day per month schedule.

• Supervise PV activities within MTDA under Senior Director QA.

• Manage own workload to ensure appropriate coverage of projects and activities

• Provide QA input to MTDA working groups and systems development as appropriate

• Provide advice on QA, PV matters to MTDA staff

• Liaise with Regulatory Affairs Department in maintaining as awareness of on-going regulatory changes

• Participate in internal and external meetings as appropriate

• Liaise with relevant parties to arrange the audits as required by audit plans

• Perform Internal Process Audits of MTDA processes

• Prepare in a timely manner [30 days] reports of audits performed

• Distribute relevant audit reports in accordance with MTDA
policy

• Assist Senior Director of QA, MTDA in providing local US perspective in relation to global activities and systems arising from MTPC

• To liaise with QA MTPC & MTPE as required on global programs

• Assist Senior Director of QA, MTDA in hosting PV related audits and regulatory inspections of
MTDA activities

• Minimum of a Bachelor's degree in scientific discipline or related field

• Minimum of 5 years of experience as ‘stand-alone’ auditor; i.e. performing audits alone.

• Experience with at least 2 regulatory inspections; at least one of which was an FDA PV Inspection.

• Related professional association membership (e.g., DIA, SQA, etc.)

• Proficiency in common office software (Windows, MS Office Suite)

• Ability to perform CSV audits is an advantage

• Willingness to travel approximately 50% both domestically and internationally.

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.