Associate Director, GRA Compliance, APAC, China and Japan応募後で応募 求人ID R0013806 掲載日 10/29/2019 Location:Singapore, Singapore
Position title: Associate Director, GRA Compliance Associate Director, Asia Pacific, China and Japan
Function: Global Regulatory Affairs Compliance
Department: Global Regulatory Affairs
- Responsible for overseeing the strategic, operational activities and implementation of Takeda’s global QMS department within Global Regulatory Affairs and Local Operating Company (LOC) Regulatory Affairs representatives. Ensure alignment with global strategic initiatives related to regulatory quality and compliance.
- Direct and lead relevant strategic initiatives and/or task force activities to address potential QMS/Compliance issues raised across Global / LOC Regulatory Affairs platforms. Ensure that Takeda is aware and responsive to external guidelines and regulations as they pertain to quality management and compliance.
- Responsible for managing, coordinating and follow up on audits and inspections related to Regulatory Affairs processes globally within the regions / LOCs.
- Manage the communication, structure and implementation of GRA processes, systems and procedures for GxP processes (e.g. training, change control, deviations/CAPAs, etc.) within the region / LOC, ensuring execution and compliance.
- Oversee the development and execution of inspection readiness activities for GRA processes within the region / LOCs.
- Responsible for demonstrating Takeda leadership behaviors.
- Lead critical GRA projects for QMS and Compliance for both strategic and operational optimization, compliance and effective implementation.
- Monitor, interpret, and communicate regulatory QMS requirements, new/revised global regulatory GxP requirements and leads communication efforts to global RA persons on changes/updates to the QMS.
- Oversee the update and management of all regional / Local information/access sites/portals/distributions; and facilitate creation, implementation and maintenance of communications and effective change management of RA processes in region/LOCs.
- 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 the development, implementation and understanding and of GRA processes and systems and the impact on the regional/LOC RA representatives. Ensure internal review of SOPs from other functional areas.
- Collaborate and build relationships with regional / LOC team members for the development and implementation of RA controlled quality documents and training materials describing GRA system related business processes via team members.
- Partner with Regional / LOC QA / Pharmacovigilance functions and interface with all disciplines in the identification and understanding of the inter-relationship between the different functions in respect to RA compliance. Ensure business critical gaps identified are closed.
- Inspections/Audits: Responsible for regional/LOC regulatory inspection or internal audit readiness for dedicated GRA/QMS/GxP inspections/audit; Ensure all inspection and audit issues related to Global RA and 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). Support regional / LOCs in addressing issues identified in CAPAs as needed.
- 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.
Education and experience:
- Bachelor degree in a science or business-related field.
- 8+ years of experience in the pharmaceutical industry, with 6+ 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.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.