Skip to main content

Search Our Jobs

Associate Director, Clinical Quality Assurance

Boston, Massachusetts

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

Back to Job Navigation (Overview)

Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

Back to Job Navigation (Success)

Back to Job Navigation (Life at Takeda)

Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

Back to Job Navigation (Rewards)

Associate Director, Clinical Quality Assurance

Apply Now
Job ID R0016399 Date posted 07/30/2020 Location Boston, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.

Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as an Asc Dir Clinical Quality Assurance in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Asc Dir CQA working on the R&D Quality team, you will be empowered to lead Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently.

Location:

Boston

OBJECTIVES:

  • Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
  • Liaise with various Takeda R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.
  • Independently manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations.  Audits conducted require advanced auditing skills and may involve technically complex assignments, including audits of high-risk studies/vendors

ACCOUNTABILITIES:

  • Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams
  • Assume complex assignments on issues or studies where there is no precedent
  • Mentor and provide support to Manager level CQA personnel, as needed
  • Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures.  Audits require advanced auditing skills and involve technically complex assignments.  Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management.  Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
  • Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
  • Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions
  • Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation.
  • Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups.   
  • Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
  • Participate in due diligence activities and process improvement initiatives as requested by management
  • May act as supervisor for temporary contractors

SCOPE OF SUPERVISION:

NUMBER SUPERVISED WORKERS

Direct

In-Direct

Employees

0

Non-Employees

0-2

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BA/BS degree required; advanced degree preferred.
  • Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
  • Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
  • Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
  • Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
  • Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
  • Strong technical writing skills; able to write quality positions, audit reports, and procedures. 
  • Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
  • Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
  • Superior attention to detail and ability to analyse complex data

LICENSES/CERTIFICATIONS:

  • GCP Quality Assurance registration/certification preferred

PHYSICAL DEMANDS: 

  • Routine demands of an office-based environment

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
  • Requires approximately 30% travel.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • 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

Empowering Our People to Shine

Learn more at takedajobs.com

#LI-LR1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0016399

Apply NowEmail Me

Back to Job Navigation (Responsibilities)

Explore the Area

Check out where you could be
working if you apply.

View Map