OBJECTIVES: (Briefly summarize the overall purpose of the position. Objectives should
be written in 3 4 bulleted statements).
- Responsible for overseeing the strategic and operational activities of the global QMS department within Global Regulatory Affairs (GRA). Ensure alignment with global strategic initiatives related to regulatory quality and compliance.
- Identify and lead relevant Strategic Initiatives and/or Task Force activities to address implementation and enhancements of QMS processes performed across global RA platform. Ensure that Takeda is aware and responsive to external guidelines and regulations as they pertain to quality management systems.
- Collaborate across R&D and Global Quality to design and implement the Takeda Global Quality system(s) within GRA with emphasis on execution and continuous process improvement approaches related to deviations, CAPA, Risk management, and training.
- Responsible for managing, coordinating, and follow up on audits and inspections corrective/preventive actions as they relate to the GRA QMS.
- Develop the structure, implementation, change management (communication) and effectiveness of GRA QMS for GxP documents and business processes to help ensure that Global RA and LOCs are compliant.
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).
- Responsible for demonstrating Takeda leadership behaviors.
- Identify and develop critical GRA projects for QMS for both strategic and operational optimization and compliance.
- Monitor, interpret, and communicate regulatory QMS requirements and leads communication efforts to global RA persons on changes/updates to the QMS.
- Define, implement and maintain the processes for the management of all GRA information/access sites/portals/distribution lists related to GRA QMS and Compliance; and facilitate creation, implementation and maintenance supportive process related documents.
- Co-development of relevant GRA metrics to track key QMS and compliance initiatives, including partnership with Strategic Initiatives and Strategic Planning directors as well as other cross-functional partners within Takeda. Communicate issues/trends to GRA leadership.
- Oversee and manages the creation, review, approval and lifecycle management of controlled quality documents (e.g. SOPs) and supporting documents within Global Regulatory Affairs. Ensure internal review of SOPs from other functional areas.
- Liase with the RA regional/LOC team members in the GRA group for the creation and development of lifecycle controlled quality documents and training materials describing system related business processes via team members.
- Partner with R&D QA and interface with all disciplines in the identification and understanding of the interfaces between the different functions in respect to QMS. Ensure business critical gaps identified are closed.
- Inspections/Audits: Responsible for QMS regulatory inspection or internal audit readiness for dedicated GRA/QMS/GxP inspections/audit; Ensure all inspection and audit issues related to Global QMS RA findings are addressed adequately; Partner with LOCs and global cross-functional partners in local inspection/audit activities as needed; and oversee corrective and preventative action plans (CAPAs).
- Lead development of training material and perform training as needed for internal/external stakeholders in relation to compliance and overall QMS activities. Ensure that training processes are compliant with relevant GRA/Local LOCs regulations. And, ensure the development of core competencies and measurement of performance (according to national law) against departmental goals and expectations.
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS
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.
- 8+ years of experience in Pharmaceutical industry, with 6+ years in Quality Assurance, Regulatory Affairs and research and development.
- 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).
- Routine demands of an office-based environment.
- 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
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
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