Manager Clinical Quality Management (CQM) provides guidance and shares expertise with OPDC staff in interpreting clinical development regulations and Good Clinical Practice (GCP) guidelines. Assures the proper planning, conduct and reporting of clinical quality management audits and prepares for and manages regulatory inspections.
- Assure timely execution of the complete Audit Schedule
- Provides oversight and directs training of Clinical Quality Management staff (internal and external) in all aspects of the quality management function; especially as it relates to conducting and hosting auditing.
- Independently conducts internal systems audits of various departments and procedures as assigned. Prepares audit reports independently, with review by CQM management as necessary. Prepares and delivers internal and external presentations as assigned, with review by CQM management as necessary.
- Independently prepares for and conducts clinical investigator audits and common specialty audits (CRO audits, SMO audits, laboratory audits, and directed audits) domestically and internationally. Assists with other external audits (bioanalytical laboratory audits, software vendor audits, packaging facility audits) as assigned.
- Reviews the audit reports of contracted auditors, and forwards to QM management for final review.
- Suggests internal and external audit targets to CQM management.
- Interviews, coaches and reviews employee performance with assistance from other CQM management team members.
- Assures completion of Corrective Actions identified via the audit process..
- Works in conjunction with the CQM management to assure coordination of effort within the department and with external contracted staff to assure compliance throughout the drug development process.
- Presents QM concerns to OPDC management, functional areas, and external OPDC customers as required, which may include other Otsuka organizations.
- Provides guidance and shares expertise in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines, conducts and reports results of quality management audits, trains auditors, prepares for and manages regulatory inspections.
- Meets with multifunctional representatives and assures departmental representation at various OPDC initiatives.
- Acts as QM liaison to one or more functions within OPDC.
- Performs activities that support overall departmental goals and objectives
Otsuka America Pharmaceutical, Inc. (OAPI) is a successful, innovative, fast growing healthcare company that commercializes Otsuka-discovered and other product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular and oncologic therapeutic treatments. OAPI is dedicated to improving patients’ health and the quality of human life.