Posted to MedZilla on 11/22/2019

Takeda Pharmaceuticals

US-GA, Supervisor, Quality Assurance SR0040630-MZ


Supervise and perform release of intermediate and final container product. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and ensure all regulatory requirements for final container release are met according to the BLA.

Create and maintain final container release process and tracking metrics, develop process flow for meeting release timelines, and develop reports for effective release reporting.

Write APR (annual product review) reports for IGI and Albumin products.

This responsible person will use of Electronic Batch Management (EBM) and will also provide guidance to other team members.

Interacts frequently with functional superiors, peers, and provide coaching, training and development of subordinates.

The incumbent will be responsible to handle multiple projects, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.

Ensure batch reviews and deviations reviews are performed in a timely manner to ensure on time release of batches.

Bachelors degree in Engineering, Science or related field or equivalent. Minimum of 4 years of QA experience in the life sciences and experience with a medical device / pharmaceutical or other similarly regulated industry preferred.

  • Must be detailed oriented and have ability to multitask
  • Must be able to maintain metrics and drive team and external partners to meet metrics requirements
  • Strong interpersonal/communication/influencing/negotiation skills
  • Strong analytical and problem solving skills.
  • Strong understand of CFR requirements for biologics and understanding of release requirements to EU preferred.
  • Must have the ability to encourage teamwork and drive decisions.
  • Must be able to handle multiple projects concurrently.
  • Requires scientific and technical knowledge in the areas of manufacturing, laboratory testing, documentation and regulations
  • Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required
  • Strongly prefer experience with final container release of biologics to multiple countries, and Annual Product Review completion.
  • Knowledge of Electronic Quality Systems( TrackWise), Process control systems(Delta V, BAS) ,Electronic Batch Record Management

Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

Must demonstrate critical thinking skills and understanding of the manufacturing/Product Disposition processes and make Quality Decisions based on knowledge of regulations and regulatory trends.

  • Manage product release process and release metrics
  • Plans and schedules the work of QA Associates to ensure release timelines are met.
  • Supervise a staff of QA Associates to ensure all regulatory requirements related to final container release is met.
  • Provide Training and coaching for the department
  • Work closely with Production Supervision, Other QA Operations Groups, Quality Systems, Quality Labs and Engineering to ensure all release requirements are being met in a timely manner.
  • Review electronic batch records, LIMS reports, identify nonconformance s and participate in investigation and Corrective and Prevention Action(CAPA) activities
  • Write, review, revise, and approve written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Oversee review and audit of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
  • Review Change Controls for impact to release process.
  • Participate in QA multi-site projects in the role of contributor, coordinator or lead.
  • Other duties, tasks or projects as assigned.

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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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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