Posted to MedZilla on 11/11/2019


Takeda Pharmaceuticals

US-MA, Quality Assurance Operations Manager SR0041846-MZ


 
 

Responsibilities include but are not limited to:

  • Management of direct reports that provide quality oversight for production operations activities.
  • Develops and maintains a routine QA On-the-Production Floor presence.
  • Works with colleagues and management to enhance Data Integrity and GDP standards across the Quality organization.
  • Has close partnership with other groups responsible for Documentation, Validation, Manufacturing, Technical Services, Investigations, Project Management, Reliability, Facilities & Maintenance, Scheduling, Raw Materials, and Disposition.
  • Monitors policies, processes, procedures and controls ensuring that the Quality Management System performance meets high level standards.
  • Ensures facility is maintained in compliance for Inspection Readiness.
  • Participates in audits and inspections.
  • Performs Batch Record Review and ensures all controlled production records are maintained, reviewed, addressed for compliance, and closed on time for product batch disposition.
  • Reports Associated Metrics and attends CI Tier boards as appropriate.

Education and Experience Requirements:

  • Minimally requires bachelor's degree, preferably in science, engineering or other related technical field.
  • 6+ years of related experience with 4+ years as a supervisor.

Essential:

Thorough knowledge of applicable procedures, specifications, regulations and standards.

  • Strong analytical and problem-solving skills.
  • Ability to manage/supervise a team of employees.
  • Good communication and leadership skills.
  • Good interpersonal/communication/influencing/negotiation skills.
  • Good project management skills.
  • Self-starting and task proficient.
  • Excellent communication between personnel, groups, and departments.

Desired:

  • Design departmental systems/ programs.
  • Implement new technologies, processes, and improvements.

Complexity and Problem Solving:

  • Employee at this level is involved in a variety of tasks of moderate to high level scope and complexity.
  • The individual will be responsible for providing guidance on prioritization and resource allocation within QA Operations and communicating priorities to staff for execution.
  • Responsible for monitoring progress towards timelines, goals and objectives.
  • Responsible for defining and implementing site-specific QA approaches based on existing guidance and quality standards, sound principles, international industry/regulatory standards, and robust scientific basis.
  • Responsible for proactively implementing preventive actions to fill compliance gaps and troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.

Internal and External Contacts

In addition to routine interaction within QA line management, key collaborations for position involve peers (Manager and Sr Manager levels or appropriate representative) from the following departments:

  • Quality Control
  • External (Global) QA groups
  • Quality Control Stability
  • Manufacturing
  • Facilities & Engineering
  • Materials Management

External: regulatory agency personnel

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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.