Enterprise Quality Auditing Auditor (Senior Manager)

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Job Description

Are you looking for a patient-oriented, innovation-driven role that inspires you and promotes your career? Then take your future in your hands and become part of our team as a

Enterprise Quality Auditing Auditor (Senior Manager)

In this role you will independently lead the planning, preparation, and execution of internal and external GxP quality audits in line with the enterprise audit schedule. You will collaborate with the Inspection Readiness, Supplier Quality, and Business Development Quality teams to deliver Global Quality objectives and serve as a primary contact for stakeholders on Enterprise Quality Auditing processes and support activities.

How you will contribute:

• Lead, plan, and execute internal and external GxP quality audits (remote, hybrid, on-site), including logistics and engagement with auditees and stakeholders.

• Perform risk-based audit preparation and execution, including data mining, document review, agenda development, and documentation of audit performance and observations.

• Monitor and improve quality audit processes and PV/Medical system audit metrics

• Assess and report risks to management, evaluate audit responses (root cause, corrective actions, timeliness), and approve audit reports and records.

• Manage self-inspections and resulting CAPAs to completion, supporting issue resolution and escalating critical concerns when needed.

• Support inspection readiness and due diligence activities, collaborating with Business Development Quality, R&D, Pharmacovigilance and Global Supplier Quality Management on supplier audits and related processes.

• Contribute to continuous improvement of quality auditing processes, strategic improvement projects, and quality culture initiatives in alignment with Global Quality.

• Support the Enterprise Quality Auditing group through participation in Communities of Practice, audit program risk assessment and planning, lead-auditor training, and ensuring implementation of procedures and policies.

• At least 50% of working time is spent on international business trips.

In this position you will report to the Enterprise Quality Auditor, R&D Functional Lead.

What you bring to Takeda:

• Scientific degree (BS or equivalent) with at least six years’ experience in R&D quality, pharmacovigilance, pharmaceutical distribution, pharmaceutical manufacturing or GxP quality assurance, including at least four years of independently leading quality audits. 

• Deep knowledge of pharmaceutical quality systems (QA, QC, systems and compliance, services and improvement) and up-to-date understanding of local and global regulations. 

• Proven ability to independently analyze complex processes and data, assess compliance, and apply strong investigation, problem-solving, risk management, and continuous improvement skills. 

• Knowledge and experience in one or more of the following: Good Distribution Processes, R&D processes, Pharmacovigilance, Medical Devices Manufacturing, Pharmaceutical Manufacturing, Bio-Pharmaceutical Manufacturing, Vaccines Manufacturing and Quality Management Systems (QMS).

• Competent in leading single-discipline audits and co-auditing internal, external (supplier), pharmacovigilance and R&D audits.

• Experienced working in international teams and effectively partnering with auditees and diverse stakeholders. 

• Fluent in written and spoken English, with strong written and verbal communication skills for engaging sites and business stakeholders. 

• Proficient with current digital tools and able to independently perform data analysis.

About Us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.

Certified as a Great Place to Work, 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.

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