Site Head of Quality

2 weeks ago


Topeka, United States CareerBuilder Full time

at MilliporeSigma in Lenexa, Kansas, United States
Job Description You are to, Lead the Quality Assurance, Validation, and Quality Control (Analytical, Microbiology, and Cell Culture laboratories) teams for the Lenexa, KS site. Act as a key member of the Site Leadership Team providing overall guidance and leadership for the site to achieve its goals while engaging and empowering all employees. Ensure compliance with ISO 9001 and cGMP requirements. Maintain Quality Systems such as Deviation, CAPA, Change Control, Complaint Management, Document Control and Training. Hire, train and develop qualified staff to ensure effective execution of Quality tasks, attaining both operational and development goals. Ensure effective execution of customer and internal audits. Drive risk reduction programs and ensure application of risk management and sound root cause analysis. Maintain established site Data Integrity program. Perform reviews of certain validation, change control, and procedural documentation. Analyze and report quality metrics and trending. Support site project roadmap by championing process improvements and digitization in Quality team's work processes.

at MilliporeSigma in Lenexa, Kansas, United States
Job Description You are to, Lead the Quality Assurance, Validation, and Quality Control (Analytical, Microbiology, and Cell Culture laboratories) teams for the Lenexa, KS site. Act as a key member of the Site Leadership Team providing overall guidance and leadership for the site to achieve its goals while engaging and empowering all employees. Ensure compliance with ISO 9001 and cGMP requirements. Maintain Quality Systems such as Deviation, CAPA, Change Control, Complaint Management, Document Control and Training. Hire, train and develop qualified staff to ensure effective execution of Quality tasks, attaining both operational and development goals. Ensure effective execution of customer and internal audits. Drive risk reduction programs and ensure application of risk management and sound root cause analysis. Maintain established site Data Integrity program. Perform reviews of certain validation, change control, and procedural documentation. Analyze and report quality metrics and trending. Support site project roadmap by championing process improvements and digitization in Quality team's work processes.

Who You Are:

Minimum Qualifications:

Bachelor's degree in a Life Science discipline 5+ years of Quality experience in a cGMP environment 2+ years of experience in a supervisory/management role

Preferred Qualifications:

5+ years of experience with ISO 9001 and GMP requirements in the Life Science industry To view full details and how to apply, please login

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