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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