ObjectiveLead and execute tasks associated with self inspection and internal or external auditing processes working with sites, operating units and functionsImplement risk based approach to the auditing program underpinned by PTRBEnsure audits are performed according to annual (fiscal year) audit plan.May be a Key Contact for Operating units for auditing, self-inspection or inspection readiness activities

AccountabilitiesAssist in developing and implementing audit activities within Takeda which focuses on a risk based approach to self inspection and auditing which identifies and resolves risksImplement a unified and shared audit services platform throughout Takeda to enable consistent and effective audit operations and Due Diligence audit support activities worldwideAssist in developing and executing strategic direction and auditing activities to achieve sustained success for regulatory inspections and supply chain product qualityAssist in creation of and execute against global audit policies, guidance, standards, procedures governing self inspection, risk identification and auditingLead and/or participate in quality audits (GMS, LOCs, and/or suppliers), including duties such as:Assessing and reporting risksEvaluating audit responses for adequacy, including root cause analysis, appropriateness of corrective actions and timelinessCommunicating results of audits in presentations and written reportsResolving issues and escalating critical concerns, as appropriate.Serves as a cGMP subject matter expert. Provides researched and fact-supported information and opinions. Educates others on regulations, quality systems and technical issues. Provides guidance and coaching on areas of responsibility, including GMP regulations, quality systems and customer awareness.May support Due Diligence activities worldwide providing subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutionsMay manage projects within the group including visibility, tracking, implementation and governance through change and project managementMay require up to 50% travelOther duties as assigned

Dimensions and Aspects

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

Knowledge and experience of Bio-Pharmaceutical, R&D and/ or Vaccines ManufacturingKnowledge and understanding of therapeutic areas as well as scientific advances and modalities for treating diseases.Knowledge and understanding of relevant regulations enabling effective partnerships across the organization

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

Ability to assemble and lead Quality Auditing teams to execute audits and support projects across Quality Auditing and Supplier QualityStrategic and tactical role to help develop, deploy and execute the quality auditing processes and tools to sites / regions and global function

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

A member of the Quality Auditing and Services teamResponsible for risk identification for internal sites and operating units and resolution of incidents

Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

Align and partner with Quality Auditing and Supplier Management staff to execute tasks in support of quality auditsAlign and partner with Quality Auditing and Supplier Management leadership team to ensure best use of QA&SM audit resourcesPartner with Operating units to support business priorities from an audit perspectiveCommunicate and train sites, operating units and global functions regarding audit management and self-inspections

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takeda’s regulatory profile to become the model for the industry

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

The complexity in the role lies in the diversity of manufacturing techniques and facilities as the role covers all geographies and therapeutic areas

Education and BehavioralScientific degree (BSc, MSc)More than 10 years of increasing management responsibility combined with knowledge of pharmaceutical manufacturingExperience across all of the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environmentFluent in written and spoken English

Core Competencies / Skills

Critical ThinkingCurrent on local and global regulationsDigital and analytical skillsInvestigation and problem solvingStrong communication skills engaging stakeholders: site, business, network, company, regulatorsRisk identification, evaluation and managementContinuous improvement

Leadership Behaviors

Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trustCreating the environment that inspires and enables peopleFocusing on the few priorities and provide superior resultsElevating capabilities for now and the future