Posted to MedZilla on 5/20/2019


Takeda Pharmaceuticals

US-CA, Director Site Quality SR0033658-MZ


 
 

Responsible for directing the Quality Operations functions (QA and QC) at the Thousand Oaks Facility to ensure product safety and efficacy. Ensure compliance to applicable local, state, federal and international regulations, good manufacturing practices, good laboratory practices, and internal standards for materials, manufacturing and/or distributed finished products, packaging and labeling. Responsible for the development and implementation of all quality systems.

Essential Functions & Responsibilities

  • Has direct line responsibility over the quality management function. Ensure that the function is adequately staffed, that training programs are in-place and that the performance review/career development program is properly implemented.
  • Ensure that appropriate design control systems and procedures are in-place to ensure product safety/efficacy and compliance with applicable regulations.
  • Ensure that applicable regulations are met in the manufacture and testing of product through the issuance of appropriate specifications and the development and implementation of Quality Systems.
  • Indirect oversight for Takeda Center-led Quality functions located in the Thousand Oaks facility.
  • Working with other functions, defines, implements, and supervises the programs aimed at assessing internal and external customer requirements and satisfaction. Responsible for managing facility level corrective action response to customer dissatisfaction.
  • Ensures that all operations are in compliance with regulatory requirements; in conjunction with the division quality function handles the relationships with the FDA and other regulatory agencies for inspections and their follow-ups. Ensures that manufacturing and QA procedures correspond to the contents of registration files and regulatory submissions.
  • Provides technical leadership and assistance in Quality matters to suppliers manufacturing components and products.
  • Provide technical assistance/leadership to other Takeda plants manufacturing components or intermediates for use in products or finished goods requirements (in cooperation with the divisions having direct line supervision over those plants.
  • Leads the manufacturing Quality organizations in implementing continuous improvement activities.
  • Provides leadership as a site SLT member.
  • Has direct responsibility for Quality Assurance functions including product releases, inspection activities, Exception Management, Change Control, and documentation control.
  • Has direct responsibility for Quality Control functions including Microbiology and Analytical Chemistry Laboratories. Direct oversight for Assay validation activities and quality operations project support.

Education & Experience, Requirements

Bachelor's degree in a scientific discipline; preferred advanced degree in a scientific discipline, business administration, or certification as a quality engineer. Appropriate scientific disciplines include Pharmacy, Chemistry, Biology, Microbiology, and Engineering. Has a requirement of a minimum of 10-12 years of management experience in quality and/or manufacturing of biologics, medical devices and/or pharmaceuticals.

Key Skills and Competencies

  • Knowledge of cGMP manufacturing.
  • Strong interpersonal skills and ability to work effectively and efficiently in a team environment.
  • Strong leadership and technical skills required.
  • Has a thorough understanding of quality assurance and quality management.
  • Has a thorough understanding of quality control including assay method development and assay method transfer.
  • Has knowledge of cGMPs for biologics and small volume parenteral products.
  • Thorough knowledge of ISO 9000 requirements and assessment of quality systems.
  • Needs excellent verbal and written communication skills.
  • Has the ability to work multifunctional, global teams within the organization.
  • Prior experience in managing and developing staff and budget accountability.

Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:

Leadership Behaviors

  • Integrity
  • Honesty
  • Fairness
  • Perseverance
  • Alignment with Patient first, Trust, Reputation and Business

Work in Environment

  • Normal office environment.
  • May be required to travel for business reasons, e.g. training and meetings.

Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments. The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements. Pace may be fast and job completion demands may be high.

Physical Demand

The overall physical exertion of this position is sedentary work with occasional entries into controlled manufacturing, laboratory and warehouses.

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.