Leader, BD & CMB Quality

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Job Description

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

OBJECTIVES/PURPOSE

• Manage assigned due diligence and divestiture activities for Quality
• Support Due Diligence activity through engagement with regional Quality teams to provide professional and detailed quality support to support Takeda Business Development and Divestiture projects
• Develops Quality strategy for management of external partnerships and management of CMB customers.
• Manages partnerships where product is out-licensed i.e. where ownership belongs to third party or shared with Takeda
• Primary Quality contact for CMB customer(s) for QIM, Inspections, Audits, QMS communication and product release support
• Delegates tasks associated Business Process ownership of Business Development & Due Diligence and CMB business support.

ACCOUNTABILITIES

• Manage Quality Divestiture and Due Diligence activities worldwide in conjunction with the Head, BD & CMB Quality.
• Support the execution of divestiture plans, collaborating with management, HR, legal, Finance and all necessary functions to ensure a smooth process and timeline
• Interface regularly with BD leads for deals, and collaborate with buyer teams to execute divestiture plans in a manner consistent with Takeda’s values of PTRB
• Lead quality related activities in support of divestiture implementation project teams
• Execute Internalization Operating Model (IOM) inconjunction with Pharmaceutical Sciences and GMS-BD
• Lead the development of an Externalization Operating Model (EOM) inconjuction with Pharmaceutical Sciences, GMS-BD, GBD and CEI.
• Manage relationship between CMB Customer(s) and Takeda manufacturing plants
• Support CMB related change controls and appropriate regulatory filings to ensure proper and consistent regulatory compliance
• Quality lead supporting business growth in due diligence and divestment activities and works in partnership with relevant stakeholders to influence quality, supply and regulatory strategy.
• Participate in or facilitate multi-site product quality investigations teams. Supports the Incident Escalation process.
• Provide strategic guidance regarding the timely implementation of multi-site global changes with regulatory impact
• Enact global audit policies, guidance, standards, procedures governing self inspection, risk identification and auditing
• Execute duties associated with one or more of the following:
  • Business Process ownership of IOM and EOM processes
  • Business Development & Due Diligence: provide subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
  • Support/attend site visits/audits by CMB customer(s) with manufacturing plants
  • Participate in CMB customer(s) business meeting
  • Establish, align, and trend Quality metrics between CMB customer(s) and manufacturing plants
  • Project Management: Oversee Project Management activities within the group including visibility, tracking, implementation and governance through change and project management
  • Track closure of divestiture TSAs
  • Establish business process for externalization operating model and align with partner organizations (GMS, RA, GS)
• Other duties as assigned

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Knowledge and experience of Bio-Pharmaceutical, R&D and/ or Vaccines Manufacturing
• Knowledge 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

• Ability to lead cross functional teams in support of Divestiture activities and In-licensing activities
• Tactical role to help develop, deploy and govern the Quality CMB processes and tools to sites / regions and global function

Decision-making and Autonomy

• A member of the BD & CMB Quality team
• Responsible for risk identification for internal sites and operating units and resolution of incidents

Interaction

• Partner with Operating units to support business priorities from a CMB, business development and divestiture perspective
• Externally this role will interact with executives and implementation teams of potential buyers, CMB customers, management and strategy consultants
• Partner with Operating units to support business priorities from a Quality perspective
• Communicate and train sites, operating units and global functions regarding business development due diligence

Innovation

• 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

• The complexity in the role lies in the diversity of manufacturing techniques and facilities as the role covers all geographies and therapeutic areas
• Must be able to travel domestically and internationally 30-50%

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Scientific degree (BSc, MSc)
• 15 years of increasing management responsibility combined with knowledge of pharmaceutical manufacturing
• Experience across all of the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environment
• Fluent in written and spoken English

Core Competencies / Skills

• Critical Thinking
• Current on local and global regulations
• Digital and analytical skills
• Investigation and problem solving
• Strong communication skills engaging stakeholders: site, business, network, company, regulators
• Risk identification, evaluation and management
• Continuous improvement

Leadership Behaviors

• Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
• Creating the environment that inspires and enables people
• Focusing on the few priorities and provide superior results
• Elevating capabilities for now and the future

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