Tanabe Pharma America
Associate Director - Quality, Standards and Training
Full-Time
No salary listed
Expert
Bachelor's
Jersey City, NJ, USA
In Person
May require domestic and international travel.
About the job
Requirements
- A minimum Bachelor's degree in a health care related field or another medical science degree combined with equivalent technical experience.
- A minimum of 8–10 years of pharmaceutical industry experience, including clinical safety/pharmacovigilance and quality, standards, and training.
- A minimum of 5 years of pharmacovigilance quality management experience, including safety quality, compliance, internal audit, and project management experience.
- Strong interpersonal and communication skills with the ability to collaborate effectively in a global matrix organization.
- In-depth knowledge of the pharmaceutical industry and quality system regulations and policies.
- Good understanding of drug safety/pharmacovigilance duties, applicable international regulations, and industry standards in a pharmaceutical company, with working knowledge of European Union and Food and Drug Administration regulations.
- Good understanding of international guidelines, including International Council for Harmonisation and Council for International Organizations of Medical Sciences guidelines, clinical development methodology, and clinical trial guidelines such as Good Clinical Practice and related regulations.
- Good knowledge of quality control/assurance or regulatory assurance in a Good Clinical Practice environment.
- Effective collaboration and communication across cultures, languages, work styles, and organizational levels.
Responsibilities
- Ensure that GDSEC and MTDA Drug Safety are compliant with regulatory requirements, corporate policies and procedures, and other applicable standards.
- Collaborate with affiliate safety departments, internal departments, business partners, contract research organizations, vendors, license partners, and specialty pharmacies to ensure drug safety and GDSEC activities comply with global and local regulations.
- Design and implement continuous quality and productivity improvement processes with senior management support.
- Collaborate across regions to ensure global standardization for GDSEC and MTDA Drug Safety.
- Collaborate with the Quality department on strategy and provide inspection-readiness support for safety-related audits and inspections.
- Determine Food and Drug Administration requirements for MTDA Drug Safety activities and provide inspection-readiness support for safety audits and inspections.
- Support Quality Management for drug safety audits and inspections.
- Work with drug safety and affiliate safety offices to address audit findings.
- Implement corrective actions from identification through resolution for 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.
- Anticipate potential regulatory or process impacts, collaborate with stakeholders to assess risk, and facilitate remedial actions when applicable.
- Drive the periodic review and update of Safety Data Exchange Agreements with business partners.
- Drive the periodic review and update of pharmacovigilance vendor procedures and agreements with pharmacovigilance-managed service providers.
- Lead the development and maintenance of policies, Standard Operating Procedures, and Work Instructions for all GDSEC and MTDA Drug Safety functions.
- Lead the review and revision of policies, Standard Operating Procedures, and Work Instructions for global safety functions.
- Monitor and update procedures based on audit and inspection findings, corrective and preventive action activities, and regulatory changes.
- Coordinate new-hire, functional, and other relevant training for MTDA Drug Safety and GDSEC.
- Manage training records in collaboration with local Continuous Improvement Department personnel.
- Develop and maintain relevant training materials.
- Develop, manage, and maintain training for MTDA and MTPA employees on post-marketing adverse event reporting requirements.
- Perform other departmental duties as assigned.
Desired Qualifications
- Two years of management experience is preferred.
- Excellent written and oral communication and interpersonal skills.
- Domestic and international travel may be required.