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Job Description

The Associate Director GRA QMS Quality is responsible for the strategic and operational activities pertaining to Global QMS Quality elements (Deviations, CAPA, Change Control) and initiatives and within Global Regulatory Affairs. He/she ensures alignment with global strategic initiatives related to regulatory quality and compliance. Develop a Quality Risk Management Program designed to assure minimal risk is assumed while aligning to key learning needs.

Principal responsibilities include but are not limited to:

• Development and leadership of the following activities at a global level in collaboration with Head of GRA Compliance QMS:
• Lead the GRA support and oversight of Deviations, CAPAs and Change Control partnering with the GRA functions (Labeling, CMC, Operations, TAU), Quality R&D and Global Quality.
• Responsible for strategic Quality and Risk Management initiatives and activities, leading the development of a risk management process to prioritize and support continuous improvement, change interventions which support QMS/Compliance and processes.
• Responsible leading the development and evolution of a “Quality Culture” within GRA, including follow up on audits and inspections, driving mitigation strategies and organizational performance.
• Lead GRA performance improvement initiatives through process and human performance improvement, identifying learning interventions, and enabling organizational and regulatory success.
• Lead GRA Quality efforts, developing process, structure, and tools that ensure communications are comprehensive across GRA, including LOCs, and Partners as required.
• Drive the overall evaluation and effectiveness of quality processes and systems throughout the global regulatory organization and its partners through:
  • Metrics Management & improvement recommendations
  • QMS process & systems effectiveness
  • Evolve Process Owner concept (define overall processes)
  • Quality & Risk Management – program development across GRA
  • Continuous Improvement
  • Audit and Inspection support
• Drive organizational improvement in partnership with GRA Leadership, and its functions.
  • GRA Non GxP records Mgt. (CV/BOPs/Non GxP Docs/forms)
  • GRA Data Analysis – QMS
  • R&D Quality and Global Quality partnership and interactions
  • Establish & Lead GRA SME Network
  • Actively represent GRA as QMS Governance SME
• Develop and sustain structure of GRA Compliance QMS ensuring connectivity and compliance within LOCs.
• Employ appropriate methodologies for implementing QMS processes across GRA and its partners (ie. LOC RA and partners).

ACCOUNTABILITIES:

• Compliance
  • Leads the development of a Quality Risk Management program for GRA projects. Applying pre-determined risk measures to GRA processes and procedures to mitigate risk and continuously improve compliance.
  • Leads the monitoring, interpretation, and communication of regulatory QMS processes and metrics requirements including remediation plans
  • Partners to develop relevant GRA metrics to track key QMS and compliance initiatives, including partnering with cross-functional Takeda partners and LOCs on strategic initiatives and planning, then communicates issues/trends to GRA leadership.
• Inspections/Audits:
  • Ensures all inspection and audit questions or findings related to GRA QMS are addressed appropriately.
  • Supports LOCs inspections/audits relating to GRA QMS
  • Responsible for GRA QMS related corrective and preventative action plans (CAPAs).

• Program Management and dashboarding:
  • Lead the ongoing management and continuous improvement of QMS tools (and dashboards) that support learning, documentation processing, non-conformance program, and CAPA management
  • Provide input on training requirements related to GRA overall QMS activities.

• General:
• Escalate issues/problems to senior management as needed
• Provides input on budgets for the group as appropriate.
• Maintains strong knowledge of current regulations, legislation, best practices and guidelines relating to Regulatory Affairs as well as GxP Learning and Quality Risk Management (QRM).
• Represents Takeda at relevant Industry Forums e.g. GMPTEA, AGxPE

EDUCATION AND EXPERIENCE REQUIRED:

• 7-10 years and a proven track record with Quality management, organizational development, quality risk management, and learning initiatives, including organization design. Able to design, implement and achieve expected results from these initiatives
• Bachelor’s degree (or equivalent) required. Masters preferred.
• Substantial experience in Pharmaceutical industry, with good exposure to Regulatory Affairs, research and development and quality assurance / compliance.
• Familiarity with inspections and audit procedures and risk management
• Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and proactively the interactions necessary for achieving business goals and objectives
• Ability to identify proactively and anticipate risk of non-compliance in a complex environment
• Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
• Acts as a positive change agent and is highly adaptable to changes in the work environment; manages competing priorities and demands
• Strong learning and development orientation and mindset including facilitation, content development, organizational diagnosis and measurement, driven to grow and develop self and others
• Excellent interpersonal, communication (written and verbal), and advanced presentation and facilitation skills
• Excellent meeting management skills, including design, preparation and facilitation
• Excellent organization, time management and project management skills, able to balance multiple projects and initiatives

Skills and Knowledge Desired:

• Systems Knowledge – extensive knowledge of Quality Management Systems, including eDMS, Deviation (Trackwise), LMS systems and QRM (Quality Risk Management)
• Regulatory Familiarity – extensive knowledge of European, US and international regulations relative to activities covered in regulatory affairs
• Industry Knowledge – strong understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes.
• Takeda Operations – in-depth understanding of Takeda’s operating philosophy, structure and methods including a thorough knowledge of the foreign‑owned parent company and any affiliates. Ability to work effectively with any internal and external Takeda department.

• Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
• Communication – ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
• Team Working - Ability to work with team members in a friendly, professional manner. Motivate and empower others. Manage teams to work productively in a high pressure environment
• Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use.
• Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
• 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.
• Project Management abilities

LICENSES/CERTIFICATIONS:

• Recommended
• ASQ Manager of Quality Organizational Excellence
• ASQ Pharmaceutical GMP Professional
• RAPS Regulatory Affairs Certification (RAC)

TRAVEL REQUIREMENTS:

• 10%, some international required.

ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):

• Bachelor’s degree (or equivalent) required. Masters preferred.
• 7 + years experience in Pharmaceutical industry, with 5 years in Regulatory Affairs, research and development or quality assurance/compliance.
• A minimum of 3 years of QMS experience. Experience in the development, implementation and maintenance of a QMS as well as GxP and QRM.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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