Posted to MedZilla on 2/16/2020

Takeda Pharmaceuticals

US-GA, Supervisor, Change Control SR0046605-MZ


Job Function and Description

  • Ownership of all aspects of the IG Change Control process
  • Responsible for managing change controls (CCs) across the lifecycle of the change from development, through implementation, to closure
  • Owner / point of contact for global initiatives / projects
  • IG point of contact for interfacility change controls
  • Identify and implement improvements targeted at increasing compliance, reducing lead time, and continually improving the change control process.
  • Serve as Trackwise change control subject matter expert within the manufacturing department and train other Trackwise users with respect to their roles and responsibilities within the change control process.
  • Own IG DCA process
  • Manage IG Department Specialists
  • As per business need, incumbent may be required to support CAPA investigations
  • Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls, etc.)
  • Train staff in general manufacturing activities
  • Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks
  • Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects.

Education and Experience Requirements

  • Bachelor of Science degree required (prefer Chemical Engineer, Biological/Biotech Engineer or Biotechnology)
  • Minimum five years relevant professional (GMP industry) experience required
  • Demonstrated ability to perform in a high performing workforce

Key Skills, Abilities, and Competencies

  • Strong knowledge of change control processes and project management required.
  • Strong problem-solving and analytical skills are required.
  • Possess knowledge of core manufacturing principles and support systems.
  • Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
  • Self-driven individual that requires minimal supervision.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
  • Prefer experience in Track-wise system.
  • Prefer knowledge of Lean Six-Sigma methodology.

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

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