Posted to MedZilla on 8/19/2019

Takeda Pharmaceuticals

US-MA, Senior Quality Assurance Specialist SR0037011-MZ


Primary Duties

The scope of this role includes primary QA Contact on quality systems from initiation to closure (deviations, investigations, CAPAs and change controls) that occur at the Lexington site. This individual will partner closely with QA Operations Floor Support peers, Lexington PIER (product Improvement Event Resolution) group and other support functions across the Lexington plant. This position will be a core team member on the QA Technical team and will have direct oversight of moderate to complex quality systems.

This individual is responsible for providing senior level support for issues of moderate complexity. Routine management and coordination of GMP compliance systems and policies for cGMP compliant facilities for bulk drug substance manufacture. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. Demonstrates a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Assures cGMP's and company procedures are followed and, if needed, procedures/policies are revised. Accountable for meeting functional area goals and objectives as they relate to departmental and Takeda goals. Responsible for adhering to GMP regulations, cGMPs, and company policies.


60% - Quality System Support (Deviations, CAPAs, Change Controls)

15% - Document review (procedures/protocols/reports)

15% - Direct manufacturing and/or Quality Control floor walks

10% - Compliance education initiatives and continuous improvement

  • Quality oversight of quality system records (deviations, change controls and CAPAs)
  • Partners with peers within Quality, Manufacturing and PIER to develop solutions for moderate to complex problems
  • Work on moderate to complex issues through data analysis and application of Takeda and regulatory requirements
  • Work with direct line management to identify areas of process improvements
  • Contribute to the development of new concepts, techniques, and standards
  • Ability to work independently without significant management oversight for routine operations
  • Provides insightful and strategic input into more complex issues
  • Ensures practices in manufacturing and support areas are consistent with quality and regulatory standards
  • May support regulatory agency site inspections
  • Champion an environment of teamwork and collaboration while maintaining a positive attitude

Education and Experience Requirements


  • 5+ years of experience within Pharma/Biotech
  • Able to perform functions in accordance with cGMPs. Knowledge of regulatory requirements and guidelines for US and Europe.
  • Ability to manage multiple competing priorities with minimal direct (routine) input from direct line management
  • Ability to proactively identify challenges and opportunities for improvement both in areas of compliance and processes


Key Skills, Abilities, and Competencies

  • This individual will be a Quality Assurance representative for the Lexington Manufacturing Plant and is empowered to make compliant decisions with the support of peers and management.
  • It is incumbent upon this individual to bring any concerns to direct line management and the Head of MA Bio Operations Quality.
  • Candidate must be able to perform the majority of work tasks with minimal to moderate supervision.

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.

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

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