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Takeda Pharmaceuticals Associate Director, GCP Supplier Quality Lead, Clinical Operations (Remote) in Helena, Montana

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Associate Director, GCP Supplier Quality Lead, Clinical Operations (Remote)

Location : Cambridge, MA (Remote)

About the role:

  • Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies

  • Serve as primary point person for key GCP strategic partners; lead key supplier quality partnership governance councils and/or internal supplier-related committees

  • Liaise with suppliers to provide compliance & management support for identified issues arising within outsourced studies

  • Lead and/or participate in GCP sponsor and supplier oversight initiatives related to quality

How you will contribute:

  • Lead the development and implementation of risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and may 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 and/or support quality governance council meetings

  • Liaise and collaborate with internal Takeda and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives

  • Analyze, report, and present metrics on supplier quality performance to management; recommend any required actions and monitor implementation.

  • 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.

  • Collaborate with Quality Compliance and Systems team to identify and mitigate cross-GXP supplier related quality and compliance issues

  • Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution

  • Lead process improvement initiatives as requested by management

  • Provide professional expertise and strong leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk

  • Participate in GCP health authority inspections, as required

  • Mentor and provide support to Manager level CQA personnel, as needed

  • May act as supervisor for temporary contractors

What you bring to Takeda:

  • 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 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 analyze complex data.

  • GCP Quality Assurance registration/certification preferred.

  • Routine demands of an office-based environment.

  • 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:

  • 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.

Base Salary Range: $130,000 - $185,000 based on candidate professional experience level.

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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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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