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Job Description

Position: Director, R&D Compliance and Risk Management

Reports to: Senior Director, R&D Quality Compliance and Systems

Location: Lexington, MA (Hybrid Workplace)

About the role:

• The Director of R&D Compliance and Risk Management is responsible for process ownership of important compliance systems within R&D Quality including Deviation, CAPA, Change Control, and Risk Management, and is considered a subject matter expert (SME) for these core compliance systems within the R&D Quality, Compliance & Systems team.

• You will be an important enabler in driving performance across the R&D Quality organization, ensuring the health of the Quality Management System (QMS) within R&D for the core compliance processes of Deviation, CAPA, Change Control, and Risk Management is monitored and improved, and ensuring that a routine gap assessment process is in place.

• You will lead foundational Quality Systems for Takeda R&D and lead their improvement from a process and systems perspective, partnering with Global Quality counterparts and system owners to develop core groups of SMEs from across functional Quality teams within R&D.

How you will contribute:

• Accountable for overall process ownership of compliance systems within R&D Quality including Deviation, CAPA, Change Control, and Risk Management, and is considered a subject matter expert for these core compliance systems within the R&D Quality, Compliance & Systems team.

• Main enabler to driving performance across the R&D Quality organization, ensuring the health of the Quality Management System (QMS) within R&D for the core compliance processes of Deviation, CAPA, Change Control, and Risk Management is monitored and improved.

• Responsible for foundational Quality Systems at Takeda R&D, and lead their improvement from a process and systems perspective, partnering with Global Quality counterparts and system owners to develop core groups of SMEs from across functional Quality teams within R&D.

• Ensure a routine gap assessment process is in place.

• Partner with applicable global teams and departments to ensure regulatory requirements are reviewed and incorporated into the QMS.

• Responsible for the R&D Quality Management System (QMS) for Deviations, CAPAs, and Change Control and ensures these core compliance systems remain current with regulatory requirements and are assessed against Health Authority inspection outcomes.

• Embed Takeda's IQS (investigation capabilities) and related investigation programs within R&D Quality including a fit-for-purpose investigation approach and investigation capabilities across Research, Clinical, Pharmacovigilance, Pharmaceutical Sciences, and Cell Therapy areas.

• Ensure performance metrics and Important Key Quality Indicators (KQI) are in place and applied across the R&D Quality teams to ensure monitoring of overall performance (system health) for important compliance processes (Deviations, CAPAs, and Change controls)

• Promote the application of a sound risk management methodology across R&D, and ensure agreement on Global Quality Risk Management. Lead primary teams of SMEs from across Functional Quality teams to promote Risk Management applications across R&D.

• Important partner with Takeda Global Quality to agree on QMS strategies including core compliance processes and competencies.

• Partner with leaders within the Quality organization (Global Quality (GQ) and R&D Quality) to build capabilities across the R&D Quality organization (e.g., Research Quality, Clinical Quality, PV Quality, Pharmaceutical Science Quality, and Cell Therapy Quality).

• As an important member of the R&D Quality, Compliance & Systems Team the role will use collective team capabilities to lead process ownership to achieve an aligned continuous improvement and right-first-time Quality oversight by the Quality teams that have oversight of Research, Clinical, PV, Pharmaceutical Science and Cell Therapy within R&D

CORE ELEMENTS RELATED TO THIS ROLE

• Understand core compliance principles and regulatory requirements across R&D with demonstrated ability to apply these principles across R&D operations.

• Experience with global and local Quality and Regulatory concepts and regulatory requirements (e.g. ICH, Annex 1, Compendia)

• You are viewed as a compliance Subject Matter Expert (SME) and, great at understanding and applying regulatory and Takeda compliance requirements.

• Experienced at developing process ownership, and developing core SME-level teams to educate and upskill the broader organization on important compliance and risk management elements.

• A necessary enabler to continuous improvement across core compliance processes and risk management within the R&D Quality organization.

• Broad knowledge of compliance regulations. develop staff and teams to build a compliance mindset and in-depth knowledge.

• Develop a cohesive view of system health (including main metrics and actions to improve the health of the system) and can partner with Functional Quality teams to increase performance.

• Project management; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of Takeda.

• Technical/Functional (Line) Expertise: Advanced knowledge and practical experience within Pharmaceutical Development, Clinical or Pharmacovigilance; Knowledge and experienced understanding of relevant regulations (GCP, GVP, GMP, GPSP) and Quality and Regulatory concepts promoting partnerships across the global network.

• Leadership: Lead through directing change, and driving change by influence and directly within the role; Lead projects with impact on the entire R&D function globally.

• Interaction: Important interactions with global R&D leaders to provide an aligned approach to achieving Quality goals. Partner with Heads of QCS functions to support team goals; Support relevant departments and work with teams to resolve complex issues; Oversee the system performance of the R&D Quality teams, and collaborate to provide direction.

• Innovation: Consider known approaches to QCS through an understanding of team members and their respective environment, and uses the Global teams; Lead process performance according to priorities and mid/long-term vision regarding the Global R&D Quality strategy.

• Complexity: Addresses complicated issues including multiple team members swiftly, supporting a dynamic organization; Addresses complex issues and leads process-focused sustainable, compliant resolution options.

• Decision-making and Autonomy: Create solutions based on the strategic needs of relevant team members, and with support from the Global QCS leaders; May lead QCS teams, providing guidance and management directly and indirectly through core SME groups.

What you bring to Takeda:

Essential Skills:

• Bachelor's degree

• 8 or more years of Quality or GxP-related experience in a pharmaceutical or related environment.

• Experience resolving complex organizational and compliance issues and implementing organization-wide actions.

• Experience developing and leading SME teams to improve overall organization performance for important processes.

• Capability with developed skills in team building, motivating, and developing people.

• Knowledge of existing and latest global/regional GCP, GVP, and GMP regulations and industry interpretations.

• Experience distilling complex compliance risks.

• Assess QCS compliance issues, associated risks, and needed action.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and a company match of charitable contributions

• Family Planning Support

• Professional training and professional development opportunities

• Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.

More about us:

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 to inspire and empowers 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.

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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.

Locations

Lexington, MA

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time