• Takeda Pharmaceuticals International GmbH
  • North Attleboro, MA
  • Non-Executive Management
  • Full-Time
  • 130 E Washington St

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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. Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work. Recognized for our culture and way of working, we??re one of only 13 companies to receive Top Global Employer status for 2018. Accountable for the Management of the incident escalation process from initiation through to timely event closure Primary responsibility for driving decision making to facilitate timely product defect reporting (FARs, BPDRs) to the US FDA across Takeda??s global commercial product portfolio. Accountable for the timely reporting of product defects to global regulatory authorities and to address any follow up questions from the authorities ACCOUNTABILITIES Accountable for driving decision making and timely actions within the Incident Escalation process in collaboration with the Operating Unit/Regions and for ensuring timely communications to the Takeda Executive Team (TET). Ensures decisions are adequately documented, filed, and executed. Leads/facilitates corporate wide training on Incident Escalation processes. Responsible for working directly with site and regional leads to ensure significant investigation are progressed into the incident escalation process in a timely manner Manages initiation, execution and tracking of Field Alerts, Biological Product deviation Reports and Field corrective actions. Responsible for the management of regulatory interactions associated with drug shortages arising from Quality events. Accountable for building an integrated incident escalation process in collaboration with key stakeholders. Participate in internal and external inspections as required. Support with timely closure of observations and audit items. Accountable for building capabilities across the Takeda to facilitate effective decision making and product defect management. EDUCATION/ EXPERIENCE Scientific degree (BSc, MSc) 10+ years of increasing management responsibility combined with deep knowledge of biopharmceutical manufacturing Experience across all of the the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environment Knowledge and experience of BioPharmaceutical Research, Development and Manufacturing; Deep knowledge and understanding of international heath authorities?? compliance requirements Senior Leadership experience including responsibility for Quality decisions Fluent in written and spoken English 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. Equal Employment Opportunity Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. EEO is the Law - EEO is the Law ?? Supplement - Pay Transparency Policy - Reasonable Accommodations Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-###-#### and let us know the nature of your request and your contact information. Search for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click ??Add? to create your job alert. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Takeda Pharmaceuticals. Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: 2) file a complaint with the U.S. Federal Trade Commission: and/or 3) file a report with your local police department.

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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