OBJECTIVES: (Briefly summarize the overall purpose of the position. Objectives should
be written in 3 4 bulleted statements).
- Responsible for the ongoing maintenance and support of the GRA Global Quality and Compliance Systems, ensuring overall compliance and effectiveness of the GRA quality system.
- Program Management of key GRA Quality and Compliance initiatives that drive continuous improvement of the GRA and Takeda systems. Coordinate and participate in audits and inspections in GRA globally.
- Facilitate the GRA compliance to the GRa Quality systems to ensure compliance to standards and new/revised Global GxP Requirements. Ensures that personnel are aware and responsive to external guidelines and regulations as they pertain to GxP Regulatory processes.
- Lead and/or support the monitoring, measurement and effectiveness of all GRA QMS processes including but not limited to; training, procedure management, change control, quality event and deviation management, audit and inspection management and QMS continuous improvement projects.
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified).
- Ensure compliance for the Regulatory Organization, including internal and external teams and partners, and support project leaders through the program management of key GRA Compliance and Quality Systems initiatives.
- Participate and execute the development and implementation of Compliance monitoring processes across Global Regulatory Affairs.
- Facilitate the implementation of inspection/audit readiness activities to include training, facilitation, internal assessments across GRA functions.
- Support and collaborate across R&D functions in the management of audit/inspection GRA related observation responses
- Partner with R&D QA and interfaces with other Takeda disciplines in the identification and management of global initiatives and participate in global projects for QMS and compliance development and maintenance.
- Develop and analyze compliance metrics, and identifies potential improvement activities. Communicate issues/trends to Compliance management.
- Maintains an expert, current knowledge of regulations, legislation, best practices and guidelines relating to Regulatory Affairs as well as GVP and GCP.
- Support GRA in Inspections and audits covering readiness activities, fulfilment of requests and the management of any outcomes.
- Develop and maintain the GRA Business Continuity Strategy and plan in collaboration with the Leadership and QMS team.
- Support overall regulatory intelligence efforts to ensure GRA maintains overall compliance to new and revisions to Global regulatory requirements as they impact GRA.
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS
line management, on the org chart
org chart; employees below direct reports.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
Education and Experience Required:
- Bachelor s Degree in a science or business-related field.
- 3+ years of experience in Pharmaceutical industry, with 3 years in Regulatory Affairs, research and development, quality assurance/compliance.
- Familiarity with inspections and audit procedures.
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
- Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
- Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
- Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
- Excellent analytical, technical and problem-solving skills
- Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
- Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization. Excellent organizational skills and ability to prioritize as well as Project Management abilities
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling
- International travel may be required in accordance with compliance/program requirements
- Ability to attend offsite meetings that may involve overnight stay
ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY): E.g. Number of years experience, ADA
ADDITIONAL EUROPE SPECIFIC INFORMATION (FOR EUROPEAN RECRUITMENT ONLY): This section should reiterate minimum/essential requirements for role