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Data Systems QA & Compliance Leader

応募後で応募 求人ID R0058150 掲載日 01/24/2022 Location:Boston, Massachusetts

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Job Description

Job Title: Data Systems QA & Compliance Leader

Location:  Boston, MA

About the role:

  • Under the direction of the Head of Data Systems Quality, this position is responsible for providing support in the management and Quality oversight of Computerized Systems Validation activities related to Takeda systems utilized by R&D.

  • Principal responsibilities include:

  • Provides professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/ GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners.

  • Liaise with various internal groups and external groups including Contract Research Organizations (CROs), regulatory bodies, expert consultants, and vendors, to maintain a high level of quality and consistency across the programs/ projects in R&D.

  • Fosters relationships with Global R&D staff to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs

  • Represent R&D in interactions with various Takeda groups outside of R&D (IT, GQA etc.) to evaluate best practices for continuous improvement of Computer System Validation compliance across Takeda.

  • Coordinates and collaborates with the internal Quality Compliance & Systems to provide consistency across QA&C process as well as programs and reporting.

  • Represent R&D in ensuring the enterprise applications are designed, validated and maintained in a manner that supports the use of these applications in compliance with Global R&D regulations.

How you will contribute:

45% - Delivery of Validation Support and Programs

  • Serve as a Subject Matter Expert (SME) in Computer System Validation requirements for systems used by Takeda’s global R&D Organization.
  • Manage the development, implementation and maintenance of the Quality Assurance programs and activities in support of R&D computerized systems used to support regulatory applications environment to ensure compliance with Domestic and International requirements.
  • Provide guidance to R&D Senior Management in preparation for regulatory inspections.
  • Serve as key company representative and SME during any global R&D agency inspection.
  • Develop positive working relationships with global R&D stakeholders and ensure that compliance objectives are met.
  • Develop and/or review all responses to regulatory agency inspections and corrective action commitments related to CSV requirements, ensure that timely responses are generated.
  • Ensure Quality Assurance oversight and involvement in Computer Validation Projects supporting R&D activities.
  • Manage/perform external audits to evaluate computerized system vendors, external hosting providers, and internal validation project deliverables.

45% - Continuous Improvement & Procedural Documentation 

  • In collaboration with other CoEs in R&D Quality Compliance & Systems identify the need for and deliver appropriate training to stakeholders/ validation teams as well as CSV training to all R&D personnel involved in CSV projects.
  • Conduct focused training as necessary.
  • Establish and maintain a periodic review system to assure computer systems are maintained in a validated state and in compliance with Procedural Documents and domestic/international regulations and guidance.
  • Direct and administer programs for measuring compliance by establishing metrics on critical quality endpoints and provide periodic reports to management with recommendations for continuous quality improvements.
  • Lead the development and maintenance of processes and procedures which support computer system validation requirements.
  • Evaluate computer system change controls and ensure adequate testing and documentation is maintained.

10% - R&D Quality Operations Leadership

  • Ensure that objectives of the Data Systems QA are defined and communicated to cross-functional groups within R&D and across the Takeda organization (Corporate/Enterprise-wide)
  • Participate in R&D Quality Compliance & Systems projects having an impact across all of R&D/ all of Takeda.

What you bring to Takeda:

  • Education and Experience Requirements

  • Bachelor’s degree in a life science or computer science required; Master’s degree in management or scientific discipline a plus.
  • At least 5 years of pharmaceutical experience. 
  • Ideal candidate will have broad experience in computer system life cycle development;/computer system validation in R&D.
  • Ideal candidate will have demonstrated experience leading cross functional teams without authority, advising on compliance related matters, and influencing Senior Leaders.

Industry-Related Awareness

  • Extensive knowledge of regulatory requirements and standards for the use of computerized systems (21 CFR Part 11, EC Annex 11, and GAMP 5).
  • Knowledge and/or awareness of GCP/GLP/GPvP/GDP regulations as applied by FDA, EMA and MHRA.
  • Strong leadership skills and ability to inspire colleagues.
  • Collaborative team player with a positive attitude who has the ability to think and act quickly and identify creative solutions to complex problems.
  • Strong judgment, project management and decision-making skills; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of Takeda.
  • Strong technical writing skills. Ability to write, quality positions, audit reports and SOPs.
  • Strong attention to detail with the ability to articulate quality-related risks and potential impact.
  • Strong knowledge of MS Word, Excel, PowerPoint, SharePoint, & Outlook.
  • Excellent communication and interpersonal skills.
  • Good understanding of the drug development processes; clinical, non-clinical, pharmacovigilance, and regulatory affairs a plus.
  • Strong knowledge and expertise in audit fundamentals and managing audit programs
  • A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project.
  • Supports a culture of innovation and a BRAVE culture, while recognizing the need for an appropriate culture of compliance.
  • Crisp decision-making and recommendations following appropriate consultation, even in times of ambiguity.

Leadership & Interpersonal Skills

  • Strong leadership skills with the ability to motivate and inspire colleagues, with tact and diplomacy.
  • Collaborative team player with a positive attitude who has the ability to think and act quickly and identify creative solutions to complex problems.
  • A self-starter, who is able to define, prioritize and manage tasks within a project.
  • Crisp decision-making and recommendations following appropriate consultation, even in times of ambiguity.  Ability to think strategically.
  • Strong judgment and decision-making skills; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of Takeda.

Communication Skills

  • Strong communication and technical writing skills. Ability to write briefing documents, quality positions, audit reports and SOPs.  Strong attention to detail with the ability to articulate quality related risks and potential impact.
  • Strong knowledge of MSWord, Excel, PowerPoint, SharePoint, & Outlook.

Other Job Requirements

10-20 % Domestic and international travel required.  Must travel globally to locations where R&D functions and activities exist. Must have a global mindset.

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.



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.


Boston, MA

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Full time