Director of Enterprise Quality Auditing Japan/APAC at Takeda Pharmaceutical Company Limited USA

Osaka, , Japan -

Full Time

Start Date

Immediate

Expiry Date

04 Feb, 26

Salary

0.0

Posted On

06 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Manufacturing, Quality Management Systems, Regulatory Guidelines, Leadership, Problem-Solving, Critical Thinking, Digital Tools, Communication, Continuous Improvement, Risk Management, Audit Processes, Team Development, Budget Management, Collaboration, Innovation, Training

Industry

Pharmaceutical Manufacturing

Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE Supervise a team of multidisciplinary auditors within the region, ensuring team development, ongoing improvement of the audit process, and engagement with the organization to achieve GQ objectives. Participate actively in the Enterprise Quality Auditing (EQA) Leadership Team, contributing to strategic decisions, engagement within the EQA group and with the organization. Own the internal and external audit process for region, ensuring timely execution of the audit plan and adherence to required timelines. Accountabilities Management/Leadership Responsibilities: Maintain a resource tracker to have visibility on team activities and to keep the team engaged. Support the development of team members by fostering development opportunities, mentorship, and training/learning. Manage the budget and approve expenses, ensuring financial awareness and accountability. Oversee holidays and time-off, maintaining work continuity, team morale and productivity. Manage training/learning requirements, policies, and visibility on applicable regulatory updates. Conduct regular supervisory activities including: Regular 1:1 meetings Quarterly Documented Quality Conversations Annual Review processes Talent reviews Goal development and review Audit Function Responsibilities: Performing audits as needed to support region and in times of resource challenges. Own the regional audit schedule, ensuring timely execution and adherence. Oversee the scheduling of audits within the region Chair peer reviews in the region, fostering collaboration and consistency. Review and approve audit reports and audit records, ensuring accuracy and consistency within and across regions. Drive process timeline adherence Drive continuous improvement of audit process. Drive consistency of audit process including but not limited to: Agendas Use of Audit Templates Use of Aide Memoirs Audit preparation activities, including stakeholder engagement Notes Documentation Observations writing and content Report writing and content Approve audit records and audit reports Audit Services Support: Assign dedicated team member support to Audit Services for specific activities. Collaborate with the Audit Services Lead on audit planning and quarterly updates. Engage in audit plan forecast and leveling activities. Develop and support KPI dashboards. Support the EQA Self Inspection Program. Continuous Improvement: Lead initiatives and projects aimed at continuous improvement. Manage group projects with team members, driving innovation and efficiency. Collaboration Responsibilities: Collaborate with other RLs/FLs on cross regional and cross discipline audit resources Work closely with Global Supplier Quality Management (GSQM), Inspection Readiness (IRE), and Business Development Quality teams. Collaborate with Global Compliance and Systems teams Collaborate with Operating Unit stakeholders and Site Quality Heads (SQHs). Deliverables: Provide region/function updates in Leadership Team meetings. Contribute and present to Staff meetings, Face to Face meetings, Global Quality Council and Communities of Practice (COP) Meetings. Provide budget forecasts based on projected audit schedule and monthly budget burn rate reports. Monthly reporting on: Resource engagement Budget forecast Projects Update Collaboration within EQA KPIs: Audit timeline metrics Training KPIs Learning KPIs Hybrid Attendance KPIs (if applicable) DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Extensive knowledge and experience in one or more of the following: Pharmaceutical Manufacturing, Bio-Pharmaceutical Manufacturing, R&D (GMP Manufacturing), Vaccines Manufacturing, Medical Devices Manufacturing, Good Distribution Processes, R&D processes, pharmacovigilance, and Quality Management Systems (QMS). In-depth understanding of regulatory guidelines/regulations and Health Authority expectations, e.g., US FDA, Eudralex, PIC/S, ICH, and ISO regulatory requirements. Leadership Ability to strategically lead audit teams and project teams, driving collaboration. Strategically develop, deploy, and govern quality auditing processes and tools to sites/regions and global functions, fostering innovation. Ability to manage challenging and time-critical situations strategically (Time management, decision-making under pressure). Compliance-driven approach and Problem-Solving skills (ability to investigate, identify root cause, and determine preventative measures). Decision-making and Autonomy Empowered to independently make decisions associated with the role. Individuals are expected and empowered to identify risk, escalate issues, and drive resolution, strategically driving continuous improvement. Identify critical risks and deviations, promptly advising on necessary process improvements or system changes. Make independent determinations on audit findings and classification of non-conformances, strategically driving continuous improvement. Collaborate with stakeholders to implement actionable solutions, minimizing operational disruptions while ensuring compliance. Interaction Collaborate with colleagues and auditees in a professional supportive manner, driving strategic collaboration. Make decisions utilizing the principles of PTRB. Apply Takeda’s values of Honesty, Fairness, Perseverance, and Integrity. Innovation Apply knowledge of scientific and regulatory trends to anticipate shifting risk. Challenge processes for efficiency and strategically drive innovation. Embrace the use of digital tools to improve process integrity and efficiency. Complexity The complexity in the role lies in the diversity of the types of quality audits that are performed in multiple pharmaceutical disciplines. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Education / Experience: Scientific degree (BS or equivalent with demonstrated experience). Minimally Eight (8) years combined experience with pharmaceutical manufacturing and/or quality control laboratories and/or quality assurance. Experience across various pharmaceutical Quality system elements (i.e., QA, QC, Systems and Compliance, Services and Improvement). Experience working in an international team interacting with other cultures. Experience with conducting and/or hosting pharmaceutical quality audits or pharmaceutical regulatory inspections. Core Competencies / Skills: Proven background leading subordinates and influencing peers. Fluent in written and spoken English. Ability to analyze complex processes and output, and assess for compliance (Critical Thinking). Current on local and global regulations. Knowledge of current digital tools (i.e. AI, Power BI) and data analysis skills. Strong written and verbal communication skills for engaging with stakeholders (Site, Business, Regulators). Investigation and problem solving, Risk identification/evaluation and management, continuous improvement. Strong written and verbal communication skills for engaging with stakeholders (Site, Business, Regulators) Investigation and problem solving, Risk identification/evaluation and management, continuous improvement ADDITIONAL INFORMATION Rules must be followed when auditing manufacturing facilities to ensure we are not endangering the quality of the product, or the safety of personnel or the auditors. In this role you may: Be required to enter controlled environments requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas. Be required to remove make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while auditing the manufacturing and/or controlled/classified environments. Enter lab/manufacturing areas and be around chemicals that require special precautions (no exposure is expected in this role). WAY of WORKING Occasionally work flexible hours to accommodate global interactions across time zones. LICENSES/CERTIFICATIONS: Externally administered auditor qualification recommended PHYSICAL DEMANDS: Sitting and/or standing for extended periods during meetings and or audits may be occasionally required. TRAVEL REQUIREMENTS: Position may require up to 25% travel for audits of meetings (regionally and internationally) Occasionally traveling after hours and/or weekends may be required. #GMSGQ #ZR1 #LI-MA1 Takeda Compensation and Benefits Summary: Allowances: Commutation, Housing, Overtime Work etc. Salary Increase: Annually, Bonus Payment: Twice a year Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45 Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave. Flexible Work Styles: Flextime, Telework Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc. Important Notice concerning working conditions: It is possible the job scope may change at the company’s discretion. It is possible the department and workplace may change at the company’s discretion. Locations Tokyo, JapanOsaka, Japan Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.

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Responsibilities

Supervise a team of multidisciplinary auditors, ensuring team development and improvement of the audit process. Own the internal and external audit process for the region, ensuring timely execution of the audit plan.