Digital Continuous Improvement and Compliance Lead (Hybrid)

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Job Title: Continuous Improvement and Compliance Lead

Location: Lexington, MA - Zurich, Switzerland (Hybrid)

The Continuous Improvement and Compliance Lead will be accountable for leading continuous improvement, compliance, and related business support activities for the Analytical Services team of the Global Oncology External Supply Small Molecule (OncESSM) Operating Unit (OpU)). The Analytical Services team oversees testing performed at external service providers (contract test labs and manufacturing organizations; CTLs and CMOs) for small molecule and Oncology products, including biologics and cell therapy products.

This role’s responsibilities will include the following:

• Serve as the compliance lead for the team to ensure a constant state of inspections readiness.
• Drive business support for the team to ensure maximize team effectiveness through the implementation and maintenance of tools such as visual management along with the oversight of team governance.
• Lead continuous improvement opportunities that will drive efficiency on the team including the implementation of digital solutions.
• Lead the implementation of high impact changes within Analytical Services.

How you will contribute:

Compliance Lead

• Serve as the compliance lead for Analytical Services.

• Responsibilities include the following for Analytical Services: coordinating the assembly of Quality Council information, attending the OpU’s compliance and systems forum, coordinating compliance related tasks (e.g., gap assessments), maintaining Quality Technical Agreements (QTAs), and supporting audits.
• Supports compliance of testing network through participation in external provider audits, data integrity verification, quality agreements, and assures the execution of requirements.
• Serve as the administrator for SLIMs or similar lab information systems. Utilize expertise in digital systems to ensure data integrity is maintained.
• Support a state of continuous inspection readiness.

BusinessSupport

• Lead implementing and maintaining a visual management system/dashboards for driving and monitoring operational and compliance deliverables.
• Support Quality Control operations; Implement industry standard processes and provide best practices solution oversight, as directed.
• Assist with complex problems of diverse scope encountered in pharmaceutical testing and the oversight of outsourced testing activities using a high degree of judgment and risk-based decision making.
• Lead the implementation of high impact changes within Analytical Services including the execution of the change controls for these changes.
• Oversee the governance of the Analytical Services team to ensure that the team is engaged in the right meetings and discussions within the OpU and outside the OpU.
• Interacts with stakeholders, regulators, industry peers, and the other Takeda Quality Units.
  • Key Stakeholders include: OncESSM ESQL, GMS Regulatory Affairs, Supply Chain, Commercial organizations, R & D Teams, Procurement, Internal Manufacturing sites, Manufacturing Sciences, Quality Systems, and Compliance; Work directly with and build cross functional relationships with Manufacturing, Engineering, MS, Quality Control, and Regulatory.

Continuous Improvement

• Implements digital solutions that automate repetitive / time consuming tasks through a partnership with OpU and Global digital teams.
• Recommends, implements, and measures KPIs for process adherence and drives continuous improvement opportunities.
  • Champion process improvement concepts - Evaluate the functional strengths and developmental areas in Analytical Services and focus on continuous improvement.
  • Measures the effectiveness of the solution and makes necessary adjustments as continuous improvements.
• Lead and support key continuous improvement projects within the scope of Analytical Services as directed, i.e., external network evaluation and streamlining initiative, implementation of SLIMs, etc.

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

• Knowledge and understanding of relevant pharmaceutical, device, and food regulations in relevant markets.
• General knowledge and experience in Pharmaceutical and Bio-Pharmaceutical Manufacturing (in particular small molecules and Oncology products).
• General knowledge of Takeda’s strategy and business performance and using that information to anticipate long-range planning for products.
• Knowledge in building dashboards that depict an organization’s performance from existing data.

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

• Ability to make Quality risk based recommendations impacting CTL services, enabling Takeda to deliver on its commitment to put patients first and build trust with society.
• Ability to operate within and across multiple regions and cross functionally.
• Ability to collaborate effectively with various cross-functional groups within the company and with external vendors. Experience with companies outside the US.
• Serves as a culture champion and example of living Takeda’s values every day (P, T, R, B).

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

• Responsible for fulfilling requests for analytical information to support Quality Councils.
• Responsible for escalating any analytical issues identified during the review of analytical information provided by CTLs or during data trending.
• Responsible for working independently or with management and other Takeda entities for issue identification and resolution at the CTL based on risk.

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

• Key Stakeholders include: OncESSM ESQL, GMS, Regulatory Affairs, Supply Chain, Commercial organizations, R&D teams, Procurement, Internal Manufacturing sites, Manufacturing Sciences, Quality Systems, and Compliance.
• Interacts with stakeholders, regulators, industry peers, and other Takeda quality units.

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

• A firm grasp of the industry, scientific and regulatory trends.
• Demonstrates an understanding of priorities, objectives, and project timelines. This includes understanding how Analytical Services activities affect the business.
• Demonstrates a good understanding of analytical methodology.

What you bring to Takeda:

• Bachelor’s Degree in Engineering, Business, Chemistry, Biology, or related discipline.
• 8 years experience in the pharmaceutical, biotech, or medical device industries and/or QA/QC laboratory environment.
• Strong project management experience.
• Strong GMP experience.
• Experience with global Health Authorities requirements in the GMP and GDP regulated area; detailed knowledge of GMP, ICH, and other relevant regulations
• Hands on experience deploying digital / software based solutions.
• Strong knowledge of Laboratory Information Systems (LIMs)
• Deep understanding of Lean Six Sigma continuous improvement philosophy.
• Cross functional and matrix management experience.
• Strong communication and technical writing skills.
• Building datasheets and dashboards in PowerBI / QLIK is a plus.
• Knowledge of SAP and digital automation.
• Strong proficiency in Microsoft tools, especially Excel and PowerPoint
• Awareness of financial processes.

Skills required:

• Communication – strong verbal and written communication skills with the ability to communicate ideas and data in a persuasive, organized, and appropriate manner.
• Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions.
• Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management.
• Proactiveness – ability to anticipate potential problems and take the initiative to address these issues.
• Regulatory Understanding – general knowledge of regulations associated with manufacturing and packaging
• Customer Service Orientation - ability to gain leadership trust and leverage relationships to provide the best possible financial plans.
• Fluent in written and spoken English.

Core Competencies / Skills

• Critical thinking
• Problem solving
• Digital and analytical skills
• Continuous improvement mindset
• Current local and global regulations
• Business oriented with a good business understanding
• Strong communication skills in engaging stakeholders

Leadership Behaviors

• Enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Drive for results, meet customer expectations, and able to influence relevant internal and external stakeholders.
• Proactive and self-motivated, with a hands-on attitude and approach.
• Excellent intercultural communication, negotiation, and influencing.
• Open-mindedness towards change and a desire to learn.
• Focusing on a few priorities and providing superior results.
• Elevating capabilities for now and the future.

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 company match of charitable contributions
• Family Planning Support
• Professional training and development opportunities
• Tuition reimbursement

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. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

This posting excludes Colorado applicants.

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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.