US-CA, Supervisor, Quality SR0035031-MZ
Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.
Every vial has a name is a core value at our Thousand Oaks CA campus, a multiproduct facility with over 20 years of operational expertise. We have an excellent opportunity for a high performing Supervisor, Quality Assurance. The selected candidate must provide thought leadership and demonstrated ability to coach and influence across the broader organization. In addition, the selected candidate must have a proven track record of ensuring safety, quality, delivery and cost are achieved in support of the business strategy.
The selected candidate will be responsible for managing the day-to-day operations for the QA Rancho facility Inspection. QA Rancho facility Inspection operation includes overseeing the quality on the floor team for Formulation and Filling and Packaging as well as maintaining the Label Stores room and QA warehouse location. QA Rancho facility operations include, but not limited to, support on CAPAs, Change Control, projects, record review, on the floor activities and maintaining the media fill program. Requires strong knowledge & experience in Formulation, Filling and Packaging operations. Identify and assess quality, product, and/or systems risk in processes according to established guidelines and Takada standard operating procedures. Proficient in facility Quality Systems particularly Change Control and Exception Management/CAPA. Responsible for developing and supervising a staff of QA personnel and ensure compliance to appropriate regulations, Corporate/Division, and applicable facility procedures. Knowledgeable of cGMP requirements for manufacturing processes in order to support day-to-day activities including troubleshooting, problem solving, decision making, and resolution execution. Proactively participates in processes and serves as a driver for general process/system improvements.
Essential Duties and Responsibilities:
Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following philosophy: Integrity, Fairness, Honesty and Perseverance.
Education and/or Experience:
Bachelor's degree in Science or Engineering. Minimum of 5-8 years of experience in quality operations or related field within a biotechnology, biologics, medical device or pharmaceutical manufacturing facility. CQM or CQE certification preferred.
Physical Demands :
May be required to work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
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 - 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
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