Posted to MedZilla on 7/17/2019


Takeda Pharmaceuticals

US-IL, QA Disposition Manager SR0037140-MZ


 
 

Accountabilities

  • Responsible for Quality disposition of products, and for conformance to regulations and global policies and processes. Manages regulatory inspections.
  • Implements the quality systems procedures and manages compliance within the QA Disposition department.
  • Manages site interactions with regulators concerning product disposition.
  • May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
  • Interacts frequently with internal subordinates, functional peer and senior group managers.
  • Owns and approves Deviation/CAPA investigations related to FLEXBUMIN operations.
  • Responsible for coaching, training, and development of the QA Disposition team.
  • Develops budget for department and ensures adherence to the budget.
  • Establishes goals for the QA disposition department in alignment with the global and site strategy, and takes action as needed to ensure timely delivery of goals.

Technical/Functional (Line) Expertise

  • Knowledge of the local and international regulatory environment and regulations for manufacture of biological products.
  • Strong analytical and problem solving skills.
  • Excellent verbal and written communication skills in English.
  • Adaptive communication and presentation skills to effectively reach different levels, including senior management.
  • Skilled in Microsoft Office applications (Excel, Powerpoint, WORD)

Leadership

  • Strong leadership skills and demonstrated success in managing a team.
  • Excellent interpersonal/communication/influencing/negotiation skills.

Decision-making and Autonomy

  • Must be able to deal with ambiguity, and take decisions under stressful conditions.

Interaction

  • Interacts with Site Head and all site functions (EHS, HR, finance, IT, production, engineering, supply chain, procurement etc.)
  • Interacts with global Quality functions and Regulatory Affairs, as well as local and global regulators.

Innovation

  • Should be familiar with Quality Risk Management principles.
  • Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.

Complexity

  • Must be able to work in controlled/classified environments requiring special gowning. Required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • Deals with plasma finished products; transfer of intermediates and products between sites/countries

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS in Science or Engineering.
  • Minimum of 5 years of experience in Quality, Aseptic Manufacturing (preferably with strong focus on fill/finish operations) or related field in the pharmaceutical industry
  • 1-2 years of management experience.
  • Demonstrate the Takeda Leadership Behaviors; be positive, accountable, and be an excellent manager of self and others.

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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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.