Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-MA, Device Quality Assurance Lead Supplier Management, Implantable Kits & Diagnostics SR0034614-MZ


 
 

Primary Role

Oversees comprehensive and GMP compliant Device Quality Assurance, supplier management, risk management, and quality assurance of Implantable Kits & Diagnostic products.

Interfaces with and provides guidance to cross functional stakeholders on matters pertaining to Device Quality Assurance, the Device Center of Excellence and to other Quality organizations on matters pertaining to Device Quality Assurance for DCP Implantable Kits & Diagnostics products for US and LATAM markets.

Establishes and drives global GMP Device and Combination product quality assurance, governance and development for external manufacturing for DCP Implantable Kits & Diagnostic products. Delivers operational Quality Assurance and ensuring compliant and robust manufacturing, packaging, testing, release distribution, review and control of Takeda s DCP products.

Supports all appropriate activities in preparation for DCP quality management review, metrics reporting, and governance for Implantable Kits & Diagnostics and/or other combination products.

Assesses product quality performance to demonstrate levels of control, capability and compliance. Drives device improvement and quality assurance and compliance to ensure robust development, manufacturing, testing, and product review. Provides technical input to incidents investigations, complaints, non-conformances, CAPAs and change controls and owns related devices/combination products specifications.

Responsibilities

  • 35%: Ensures robust Supplier Quality Management program, auditing of suppliers, quality agreements, documentation and governance and management of the quality interface with responsibility for the ultimate release of Implantable Kits & Diagnostics and/or combination products.
  • 30%: Assures adequate Device QA support across the end to end lifecycle and integrated supply chain for all Implantable Kits & Diagnostics and/or combination products to ensure timely release of products and compliant with all cGMP, SOPs, clinical, device, and regulatory requirements. Accountable for device CAPA, deviation and complaint investigations and incident escalation execution for Device and Combination product derived incidents. MDR and Vigilance oversight.
  • 20%: Implantable Kits & Diagnostics along with other combination products enable a smooth transition from clinical to commercialization, launch, and through lifecycle management. Supports Risk Management and oversees all Post Market activities for the kits. Management Review, CAPA Review Board and Global Product Review oversight for all Implantable Kits & Diagnostics Kits/Combination Products.
  • 10%: Influences QMS strategy to enhance and execute sustainable Device QA support for internal and external manufacturing, packaging, testing and release of the kits containing devices (combination products), IDDDs and IVDs. Launch activities and Regulatory filings
  • 5%: Participates in ongoing Quality initiatives and Operational Excellence.

Education & Experience Requirements

  • Essential: Bachelor s Degree in BS in Engineering or equivalent technical discipline required, and at least 7-10 years of experience working with medical devices or combination products in a regulated healthcare industry, with a minimum of 5 years Quality Assurance and/or Quality Engineering; Expert knowledge of international regulations for Device and Combination Products with full understanding of US and International requirements for Design Control, Supplier Management and Risk Management guidelines, Post Market, CAPA primarily emphasis on 21 CFR Part 4, 820, 803, MDD/IVD, ISO 13485, MDSAP, MDR/IVDR and ISO 14971; Experience with Class I & II & III sterile and non-sterile medical devices; Experience through interacting and collaborating with cross-functional global teams; Experience with project/program management and operational excellence preferred; Experience working with external manufacturing partners; experience in quantitative analytics; Experience assessing root cause analysis and effective investigation practices; strong operations background to ensure value added and effective quality operations; experience driving out inefficiencies and improving turnaround times; understanding of GDPs and global supply and distribution networks.
  • Desired: Advanced Degree; Experience working in a post-market quality support function preferred

Other Requirements

Domestic and international travel up to 25% for business meetings with local staff, corporate peers/collaborators, Device Supplier Audits, Contract Manufacturing Operators and to stay current with professional development opportunities.

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 - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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