Lead, Quality Audits
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.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
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Lead, Quality AuditsApply Now
- Lead and execute tasks associated with self inspection and internal or external auditing processes working with sites, operating units and functions
- Implement risk based approach to the auditing program underpinned by PTRB
- Ensure audits are performed according to annual (fiscal year) audit plan.
- May be a Key Contact for Operating units for auditing, self-inspection or inspection readiness activities
- Assist in developing and implementing audit activities within Takeda which focuses on a risk based approach to self inspection and auditing which identifies and resolves risks
- Implement a unified and shared audit services platform throughout Takeda to enable consistent and effective audit operations and Due Diligence audit support activities worldwide
- Assist in developing and executing strategic direction and auditing activities to achieve sustained success for regulatory inspections and supply chain product quality
- Assist in creation of and execute against global audit policies, guidance, standards, procedures governing self inspection, risk identification and auditing
- Lead and/or participate in quality audits (GMS, LOCs, and/or suppliers), including duties such as:
- Assessing and reporting risks
- Evaluating audit responses for adequacy, including root cause analysis, appropriateness of corrective actions and timeliness
- Communicating results of audits in presentations and written reports
- Resolving issues and escalating critical concerns, as appropriate.
- Serves as a cGMP subject matter expert. Provides researched and fact-supported information and opinions. Educates others on regulations, quality systems and technical issues. Provides guidance and coaching on areas of responsibility, including GMP regulations, quality systems and customer awareness.
- May support Due Diligence activities worldwide providing subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
- May manage projects within the group including visibility, tracking, implementation and governance through change and project management
- May require up to 50% travel
- Other duties as assigned
Dimensions and Aspects
Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and complexity of technical knowledge)
- Knowledge and experience of Bio-Pharmaceutical, R&D and/ or Vaccines Manufacturing
- Knowledge and understanding of therapeutic areas as well as scientific advances and modalities for treating diseases.
- Knowledge and understanding of relevant regulations enabling effective partnerships across the organization
Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)
- Ability to assemble and lead Quality Auditing teams to execute audits and support projects across Quality Auditing and Supplier Quality
- Strategic and tactical role to help develop, deploy and execute the quality auditing processes and tools to sites / regions and global function
Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
- A member of the Quality Auditing and Services team
- Responsible for risk identification for internal sites and operating units and resolution of incidents
Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
- Align and partner with Quality Auditing and Supplier Management staff to execute tasks in support of quality audits
- Align and partner with Quality Auditing and Supplier Management leadership team to ensure best use of QA&SM audit resources
- Partner with Operating units to support business priorities from an audit perspective
- Communicate and train sites, operating units and global functions regarding audit management and self-inspections
Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
- A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takeda’s regulatory profile to become the model for the industry
Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- The complexity in the role lies in the diversity of manufacturing techniques and facilities as the role covers all geographies and therapeutic areas
Education and Behavioral
- Scientific degree (BSc, MSc)
- More than 10 years of increasing management responsibility combined with knowledge of pharmaceutical manufacturing
- Experience across all of the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environment
- Fluent in written and spoken English
Core Competencies / Skills
- Critical Thinking
- Current on local and global regulations
- Digital and analytical skills
- Investigation and problem solving
- Strong communication skills engaging stakeholders: site, business, network, company, regulators
- Risk identification, evaluation and management
- Continuous improvement
- Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
- Creating the environment that inspires and enables people
- Focusing on the few priorities and provide superior results
- Elevating capabilities for now and the future
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0039247