About this role
KEY RESPONSIBILITIES
Quality (Quality, Compliance):
Ensure that GDSEC and MTDA DGS is in compliance with regulatory requirements and MTPC corporate policies and procedures and other applicable standards
Collaborate with affiliate safety departments, external departments within MTPG and business partners (e.g. CROs, Vendors, License Partners, Specialty Pharmacies) to ensure that MTDA drug safety and GDSEC activities are compliant with applicable global and/or local regulations
Design and implement continuous quality and productivity improvement processes with MTDA DGS and GDSEC senior management support
Collaborate across regions to ensure appropriate level of global standardization for GDSEC and MTDA DGS
Collaborate with MTPC Quality department on strategy and provide inspection-readiness support safety related audit and inspection
Determine FDA requirements for MTDA DGS activities and provide inspection-readiness support related to safety audit and inspection
Support MTPC Quality Management for drug safety audit and inspection
Work with MTDA DGS and GDSEC and appropriate affiliate safety offices to address audit findings
Implement all corrective actions from identification through resolution, for all valid deviations, identified by internal audits or regulatory inspections
Contribute to the development and maintenance of compliance tracking and reporting systems and tools
Develop and distribute compliance reports, as applicable
Anticipates potential regulatory or process impacts and collaborates with internal and external stakeholders to assess the risk and if applicable, facilitates implementation of remedial action(s).
Drives the periodic review and update of Safety Data Exchange Agreements with Business Partners.
Drives the periodic review and update of PV vendor procedures/agreements with PV-managed service providers.
Standards:
Lead the development and maintenance of Policies, SOP (Standard Operational Procedures) and WIN (Work Instructions) for all GDSEC and MTDA DGS functions
Lead review and revision of policies, SOPs, WINs for all MTPG global safety functions
Continually monitor and update procedures as necessary based on findings of audits/inspections, CAPA activities, regulatory changes, as necessary
Training:
Coordinate relevant MTDA DGS and GDSEC new hire training, functional training and all other relevant trainings
Manage MTDA DGS and GDSEC training records in collaboration with local Continuous Improvement Department personnel as appropriate
Develop and maintain relevant MTDA DGS and GDSEC training materials
Develop, manage and maintain training to all MTDA and MTPA employees on requirements for post-marketing adverse event reporting
Performs other departmental duties as assigned
Education:
Minimum Bachelor's degree in health care related field or other medical science degree combined with equivalent technical experience
Professional Experience:
Minimum of 8 - 10 years of pharmaceutical industry experience including clinical safety/pharmacovigilance and quality, standards, and training, and 2 years of management experience preferred
Minimum 5 years’ experience of PV quality management (safety quality, compliance, internal audit experience, and project management)
Knowledge and Skills:
Strong interpersonal and communication skills with ability to collaborate effectively with other groups in a global matrix organization.
In-depth knowledge of pharmaceutical industry and knowledge of quality system regulations and policies
Good understanding of drug safety/pharmacovigilance duties, applicable international regulations and industry standards in pharmaceutical company, and working knowledge of EU / FDA regulations.
Good understanding of international guidelines, i.e. ICH/CIOMS, clinical development methodology and knowledge of clinical trial guidelines (e.g., GCP) and related regulation
Good knowledge of quality control/assurance, or regulatory assurance in a GCP environment
Excellent written and oral communication and interpersonal skills
Effective collaboration and communication with all various cultures, languages, work styles, and levels within the global organization
May require domestic and international travel
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. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: