OBJECTIVES/PURPOSE :

Drives strategic Quality activities to ensure that non-clinical GLP study activities conducted in-house and outsourced are in compliance with GLP or applicable regulationsFosters relationships with R&D staff to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programsProvides professional expertise, guidance and strong leadership in Good Laboratory Practices (GLP) and other applicable regulatory requirements (e.g. CAP, CLIA, BA Guidance) to proactively identify compliance issues/risks in all Nonclinical, analytical and Bioanalytical studies within the organization and its external partners (as applicable)Provides regulatory / compliance expectations related to GLP and regulated laboratory activities to our stakeholders as subject matter experts (SMEs) and advise on quality related issuesProvides oversight and leads QA professionals responsible for Research Quality Assurance supporting regulated laboratories and GLP activities (as applicable)Lead and assess (directly or via management of contract auditors) external service providers conducting GLP study activities and external analytical regulated laboratory activitiesLead internal, external and supplier quality audits to assess quality management systems, adherence to applicable regulations/procedures and appropriateness for use by quality standardsAssist in the development of key performance indicators (KPIs) and quality metrics for quality to drive process improvements

ACCOUNTABILITIES:

Provides professional expertise, guidance and leadership in Good Laboratory Practices (GLP) and other applicable regulatory requirements (e.g. BA Guidance Document, ISO, OECD, CLIA) to proactively identify compliance issues/risks in all Nonclinical, Analytical and Bioanalytical studies within the organization and external suppliers (as applicable)Liaise with various internal groups and external groups including Contract Research Organizations (CROs), regulatory bodies, expert consultants and vendors, to maintain a high level of quality and consistency across the programs / projects in ResearchAccountable for identifying quality risks to non-clinical programs and developing mitigation strategies in partnership with the businessLeads and implements appropriate audit programs to ensure that regulated non-clinical studies are in compliance with applicable regulations.Participate in regulatory inspections and ensures GLP inspection readiness (as applicable)Keeps up with the up-to-date applicable regulations and ensures that Research Quality staff is trained on the interpretation and application of applicable regulations.Independently perform qualification audits of suppliersMaintain GLP training program to ensure that personnel are appropriately trained to carry out GLP responsibilities Review and audit compliance documents, SOPs, and protocols in support of GLP regulated activities

DIMENSIONS AND ASPECTS :

Technical/Functional (Line) Expertise

Comprehensive knowledge and understanding of domestic and international GLP regulations, Bioanalytical Guidance Document and good documentation practices.Thorough understanding of analytical assays, method development and laboratory operationsIndependent  broad range QA Auditing skills and ability to articulate quality related risk and potential impactTechnical writing skills Firm understanding of the drug development processes, nonclinical operations, regulatory compliance and GLP auditing

Leadership

Develop and maintain audit plans on an annual and ongoing basisApply strategic thinking to the oversight and management and development of supplier audit planning & schedulingUpdate and maintain required Research Quality Assurance audit program (internal and external) related documentationEnsure alignment with Global Quality approachEnsure compliance with change management processes and communicate to stakeholders regulatory compliance changes and updates (as applicable)

Decision-making and Autonomy

Independently perform issue analyse assessments and determine impactApply problem solving skill to achieve a compliant resolutionAble to formulate an strategic approach for difficult complex issues

Interaction

Talent to communicate and persuade others to entertain a more compliant approachSkills to defuse volatile/emotional situations to facilitate a cooperative conservation and build relationships

Innovation

Strong judgment, project management and decision-making skills; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of TakedaSupports a culture of innovation, while recognizing the need for an appropriate culture of compliance

Complexity

Mature, problem solving attitude, exhibits judgment and realistic understanding of the issues; able to use reason even dealing with emotional topics and have the interpersonal skills to deliver tough messagesRequires a high degree of problem-solving ability; understanding objectives and processes across R&D and corporate functions and when escalation is necessary

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: 

Bachelor’s degree required (or equivalent combination of education and experience).  Advanced degree preferredMinimum of 9 years of increasing responsibility and experience in the pharmaceutical industryMinimum 6 years GLP QA experience.In depth knowledge of international regulatory requirements and industry guidelines on GLPAbility to influence and work effectively with various business partners.Advanced knowledge of the drug development process.Demonstrates excellent written and verbal communication skills in English.Work independently with minimal supervisionDemonstrates excellent business skills such as critical thinking, strategic planning, and time management