Posted to MedZilla on 5/20/2019


Takeda Pharmaceuticals

US-MA, Director Quality Control Operations SR0034800-MZ


 
 

Primary Role

The Director QC Operations is responsible for testing oversight of Analytical (HPLC, UPLC, CE), Biochemistry, Cell Biology, Raw Materials, and Microbiology functions at the Quality Laboratories at the Lexington site. The labs are accountable for the on-time delivery of data in support of in-process, release and stability activities.

In this role, the individual will drive accountability to deliver to targets for commercial and clinical testing of defined site-based and external programs, collaborate on continuous improvement (CI) activities, engage with peers across the Lexington site to influence daily operations, and progress lean labs initiatives. The individual is directly responsible to maintain labs in an inspection-ready and GMP-compliant state. In addition, the introduction of new technology to improve sustainability and compliance is expected.

The role requires direct management of individuals, including goal setting, performance feedback, skills development, and mentoring.

Job Summary/Operations Involvement:

Responsible for the successful operation of activities of major significance to the organization. May become involved in daily operational activities to drive improvement and accountability. Ensures that overall budgets, schedules, and performance standards are realistically set and attained.

Responsibilities:

  • Oversight of daily laboratory operations, including tiered board attendance and governance activities: 20%
  • Direct management of individuals, including goal setting, performance feedback, skills development, and mentoring. Training and development: 20%
  • Strategic initiatives, capacity planning and budget activities: 20%
  • Collaboration with peers in Quality organization to support major lab programs (OOS/Investigations, Instrument Qualification, Data Integrity): 20%
  • Laboratory support, for quality systems records such as change controls and Operational Excellence activities including Lean Lab activities: 20%

Education & Experience Requirements:

Essential:

  • Minimum of a bachelor s degree in a scientific discipline and +10-15 years of related experience in Quality Control laboratory.
  • Demonstrated ability to solve problems, develop plans and advance to completion on time and in full.
  • Prior people management experience with a focus on developing staff.
  • Diverse technical understanding and ability to apply skills/knowledge to new technology
  • Knowledge of cGMPs and current regulatory expectations.
  • Demonstrated ability to drive a strong continues improvement and safety culture.

Other Requirements

Routine travel is not expected, but periodic opportunities for training and development may require limited travel.

The following physical abilities are required in order to fulfill the job duties:

  • Ability to work around chemicals as an observer only. The role is not expected to perform lab operations.
  • Ability to wear basic personal protective equipment such as gloves, gowning, and eye protection while in laboratory areas.
  • Ability to walk and stand for periods of time.

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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