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Job Description

About the role:

The Quality Compliance and Systems, Senior Manager is responsible for ensuring the quality of processes and product outputs by defining activities, processes, and standards. This role involves auditing, monitoring, and determining the quality of processes or outputs against defined internal and regulatory standards, contributing to Takeda's mission of delivering quality products.

How will you contribute:

• Partner with key stakeholder group(s) to execute strategy to achieve and maintain the desired high state of quality on an ongoing basis to understand, communicate and mitigate compliance risks.

• Assist in the development and maintenance of quality standards that are compliant with global regulatory requirements, aligned with Takeda Global Quality requirements and cur-rent industry trends and best practices.

• Lead monitoring and management of quality events/deviations investigations to ensure business owners identify appropriate root cause of the finding(s) and develop achievable and sustainable actions to address the issue within the established timelines.

• Host PV business partner audits.

• Support preparation activities for audits and inspections; prepare inspection readiness plans, conduct training; conduct inspection readiness assessments/mock interviews and coach subject matter experts.

• Manage all audit and inspection related documentation to completion and ensure filed accordingly and all associated records are up to date.

• Support other regulatory authority inspections in all GxP areas (i.e., GCP, GMP).

• Evaluate adequacy and completeness of CAPAs and Effectiveness Checks (ECs) originated from audits, and/or quality events/deviations.

• Support R&D Quality Compliance and Systems and stakeholders for internal audits related to PV System.

• Supports management with strategic approach to understand health of the PV System; communicate and present summaries of quality event/deviations, audit findings, trends, risk register, KPIs with recommendations to mitigate risks and support continuous improvement.

• Collaborate with key PSMF contributors to ensure timely and accurate update and completion of the PSMF.

• Perform Quality review of new/updated PV procedural documents as assigned.

• Oversee the change control lifecycle activities impacting the PV system in alignment with Global Quality internal policy and procedures.

• Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. compliance risk(s).

What you bring to Takeda:

• Bachelor’s Degree required in scientific or allied health/medical field.

• Minimum 6 -9 years of increasing responsibility and relevant experience in global pharmaceutical industry, with at least 3 years of experience in people and/or process management experience in GVP Quality Assurance/Compliance.

• Experience in managing complex organization compliance issues and in identifying and implementing organization-wide compliance initiatives.

• Skilled in managing global, cross-functional projects.

• Strong working knowledge of global GVP regulations and guidance; good working knowledge of global GCP regulations and guidance. Understands the regulatory environment for global pharmaceutical companies, as well as best practices in the Pharma industry to satisfy regulatory requirements (e.g., US/EU/MHRA Regulations & GVP-ICH Guidelines).

• Demonstrate advanced knowledge in the conduct and reporting quality events/deviations, regulatory inspections-audits findings, and the translation of findings into corrective and preventative action plans that mitigate risks to the company, PV system and data integrity.

• Communication skills: Must professionally, clearly, concisely, and consistently communicate to external and internal customers both verbally and in writing. Must also be able to demonstrate professional presentation skills.

• Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution with internal and external stakeholders to facilitate resolution of differing opinions and ensure adherence to quality standards and timelines.

• Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner and proactively communicating changes in pre-established goals and deadlines.

• Ability to navigate a fast-paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to change priorities and work effectively under pressure; organizational and prioritization skills a must to meet established timelines.

• Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.

• In-depth understanding of the good practices for the creation and management of a Quality Management System.

• Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct, and track deliverables and to communicate with internal and external team members (experience with Trackwise is preferred).

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$137,000.00 - $215,270.00

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, MACHE - Glattpark (Opfikon) - Zurich HQ

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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