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Head Global Quality Compliance and Systems (Hybrid)

Employer
Takeda
Location
Lexington, Massachusetts
Start date
Feb 21, 2024

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Job Details

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Job Description

Job Title: Head Global Quality Compliance and Systems

Location: Lexington, MA

About the role:

The Head Global Quality Compliance is accountable for establishing, maintaining and improving Quality governance, processes and overall capabilities across the GQ enterprise (R&D, GMS, Biolife, Vaccines and Commercial Quality).

This includes oversight and sustainability of the overall Global QMS enterprise, Quality Management and Improvement, Quality Systems, Auditing and the Inspection-Readiness Process.

  • This function owns and drives Takeda’s ability to prevent and proactively address product and non-product quality issues and incidents and strategic oversight to ensure timely incident escalation and actions which align with Quality Risk Management and Takeda’s values and Patient Trust Reputation and Business (PTRB)..
  • The responsibilities of the function cover governance, processes, platforms, systems and capability building for the Takeda Quality organization, ensuring clarity of policies and procedures and the mechanisms which tallow adherence to those policies and procedures.
  • The function ensures that risks posed to our patients by the supply base are identified and managed by the Global Quality Audit function. This includes quality support and oversight for business development projects globally; as well as audits of internal Takeda manufacturing facilities. This function also minimizes risks by ensuring robust inspection readiness, inspection response and CAPA execution as monitored by the Global Quality compliance function.
  • This function develops and co-ordinates the external engagement program for Global Quality.

To support the above responsibilities, the function drives innovation and sustainability via simplification, capability building and the implementation of strategic electronic systems and data, digital and technology.

How you will contribute:
  • Quality systems IT digitization
  • Information systems management
  • QMS (Quality Mgm. system)
  • Digital Strategy
  • Quality Governance
  • Quality Knowledge Mgmt.
  • Inspection Readiness and site support
  • Risk management program
  • Product Quality surveillance
  • APR program
  • Develop and lead a global team for Quality Compliance and Systems

What you bring to Takeda:

Education / experience

  • Scientific degree (BSc, MSc)
  • 15+ years of increasing management responsibility combined with deep knowledge of biopharmceutical manufacturing
  • Experience across all of the the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environment
  • Knowledge and experience of BioPharmaceutical Research, Development and Manufacturing;
  • Deep knowledge and understanding of international heath authorities’ compliance requirements
  • Senior Leadership experience including responsibility for Quality decisions
  • 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

Technical/Functional (Line) Expertise

  • Knowledge and experience of Bio-Pharmaceutical Research, Development and Manufacturing
  • Knowledge and understanding of all 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 a global Quality Compliance and Systems Function including all aspects of performance
  • Ability to build a global patient-centered best in class organization, develop diverse talent and elevate organizational performance
  • Ability to make Quality decisions impacting Market Actions etc enabling Takeda to deliver on its commitment to put patients first and build trust with society.

Decision-making and Autonomy

  • DOA limits to be defined in line with new TMAP
  • A member of the GQLT – setting the long term strategy for Global Quality
  • Responsible for Global Quality Councils resulting management actions
  • Responsible for taking Market Action decisions impacting on market products
  • Full budget accountability for this function

Interaction

  • Key interactions across all manufacturing and Quality regional and operating unit teams
  • Key interface with regulatory bodies and think-tanks bringing regulatory changes into the organization to shape approaches and long term direction

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
  • This function drives innovation and sustainability via implementation of strategic electronic systems

Complexity

  • This is a global role with the most significant impact on Takeda’s ability to build a Quality Management system that supports truly global products. The output of this team is applied to teams at all stages of the lifecycle.

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
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. 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.
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 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.

#GMSGQ #ZR1 #LI-MA1

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

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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