at Takeda Pharmaceuticals in Montpelier, Vermont, United States
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as Head, Global Regulatory Affairs Compliance and Quality where you will provide leadership to a global team of quality and compliance professionals that is accountable for meeting to global health authority requirements and expectations across the product life-cycle. Lead all key elements of the Takeda and vendor/partner regulatory compliance and quality management system across all Global Regulatory functions and ensure alignment with global strategic initiatives and systems related to regulatory quality and compliance.
You will also be a strategic partner with the Global Regulatory Affairs organization in the development and monitoring of regulatory labelling compliance processes and systems. Lead and manage day-to-day compliance support for GRA and/other business groups that may be appropriate, including audits and inspections and support for global regulatory compliance activities.. As part of the Regulatory Operations team, you will report to the Head Regulatory Operations.
How you will contribute:
+ Develop and drive a pragmatic integrated global GRA compliance / quality strategy.
+ Building, engaging and providing leadership to an outstanding and diverse team of compliance champions. Being responsible for the professional accomplishments and development of global regulatory compliance organization.
+ Ensure effective processes/procedures are established and implemented across all regions. Ensure positive reinforcement mechanisms are implemented to engage staff to be compliant
+ Review periodically compliance and quality operational metrics to identify emerging trends, and develop and implement appropriate action plans to ensure continuous improvement and sustained compliance. Communicate issues/trends to GRA leadership.
+ Manage and lead critical GRA projects for QMS, compliance and strategic initiatives and other, as needed, for strategic and operational optimization and compliance
+ Ensure effective collaboration with and serve as an RA compliance advisor to other functional partners within Global Quality and the Global Development Office (PV, Clinical Development Operations, Clinical Supplies Management, and Development Support) to support the culture of compliance.
+ Partner with relevant internal and external partners and interface with all disciplines in the identification and understanding of the interfaces between the different functions in respect to GRA activities. Ensure business critical compliance gaps identified are closed.
+ Oversee and monitor fulfilment of our commitments to Regulatory Authorities
+ In partnership with Global Regulatory Intelligence and Policy (GRIP) and SME, interpret and communicate regulatory QMS and compliance requirements and lead the gap assessment and implementation of new or revised cGxP regulations, impacting Takeda GRA processes and procedures.
+ Establish, manage and measure the creation and implementation of life-cycle controlled quality documents and training learning plans for the implementation of Takeda’s Global Quality systems within the GRA function and the Local Operating Company Regulatory affairs personnel.
+ Facilitate creation, implementation and maintenance supportive process related documents (e.g. “How we work in RA”).
+ Responsible for regulatory inspection or internal audit readiness for dedicated GRA/QMS/labelling/GxP inspections/audit. Ensure all inspection and audit issues related to Global RA and findings are addressed adequately. Partnering with LOCs and global cross-functional partners in local inspection/audit activities as needed. Oversee corrective and preventative action plans (CAPAs); and supporting regional/LOCs in addressing issues identified in CAPAs as needed
+ Collaborate with training assets to ensure that training processes are compliant with relevant GRA/Local LOCs regulations. Leading development of training material and perform training as needed for internal/external stakeholders in relation to compliance and overall compliance activities. Ensuring the development of core competencies and measurement of performance (according to national law) against departmental goals and expectations
+ Effectively implement, train and monitor the Regulatory affairs roles within Takeda Global Quality Management systems and process, ; i.e. change control, quality event management and CAPAs, documentation control and compliance training.
+ Develop mitigation plans to proactively reduce risk in partnership with critical stakeholders, as needed.
+ Maintain an expert, current knowledge of regulations, legislation, best practices and guidelines relating to Regulatory Affairs as well as GxP, Annex 11 and 21 CFR Part 11 validated systems.
+ Partner with Takeda Quality and Compliance organization to ensure effective implementation of the Global Quality and Compliance systems within Global Regulatory Affairs
+ Collaborate with GRA Business Operations team members to establish compliance oversite and monitoring of any outsourced or vendor/partner relations who perform regulatory operations in accordance with Takeda GRA systems and processes.
+ Identify potential areas of compliance vulnerabilities and risks related to GRA functions and processes and develop strategic initiatives and/or mitigation plans to reduce risk.
+ Bachelor’s Degree in a science or business-related field is required.
+ 12+ years of experience in Pharmaceutical industry, with 10+ years in Regulatory Affairs, research and development, quality assurance/compliance is required.
+ Formal experience in the management and facilitation of inspections and audit procedures.
+ Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
+ Experience in implementing or performing assessments of compliance to processes and procedures
+ Understanding in the Pharmaceutical development as it relates to regulatory affairs role within GxP global regulations
+ Demonstrated knowledge of global health authorities, regulations, product approval and life-cycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
+ Direct experience in the pharmaceutical industry or related field required
+ Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus
+ Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
+ Strong management and interpersonal/communication skills, with a proven ability to deal effectively with a variety of personnel
+ Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make important talent decisions.
+ Health care business acumen with a comprehensive understanding of the pharmaceutical industry
What Takeda can offer you:
+ Comprehensive Healthcare: Medical, Dental, and Vision
+ Financial Planning & Stability: 401(k) with company match a