Associate Director - Quality, Standards and Training
Apply NowCompany: Mitsubishi Tanabe Pharma America
Location: Jersey City, NJ 07305
Description:
Company Description
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.
Responsible for creating and maintaining standardization and oversight of all drug safety quality activities and for leading the development and implementation of continuous improvement initiatives to support the operational objectives of the global and regional drug safety organization. This individual is responsible for performing and managing quality activities in support of Drug Safety, including but not limited to: Audit/Inspection Readiness, PV Training, PV Deviation Investigation Management, Ad-hoc/Aggregate Report QC, ICSR QC,PV Project Management, PV Agreement Maintenance, and PV Documentation Management.
Job Description
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
Qualifications
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
Additional Information
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:
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.
Responsible for creating and maintaining standardization and oversight of all drug safety quality activities and for leading the development and implementation of continuous improvement initiatives to support the operational objectives of the global and regional drug safety organization. This individual is responsible for performing and managing quality activities in support of Drug Safety, including but not limited to: Audit/Inspection Readiness, PV Training, PV Deviation Investigation Management, Ad-hoc/Aggregate Report QC, ICSR QC,PV Project Management, PV Agreement Maintenance, and PV Documentation Management.
Job Description
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
Qualifications
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
Additional Information
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: