Lead, Quality Audits
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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
- 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
- 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
- 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
- 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
- The complexity in the role lies in the diversity of manufacturing techniques and facilities as the role covers all geographies and therapeutic areas
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Scientific degree (BSc, MSc)
- 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
Job ID R0015965