BioSpace
Associate Director Quality Assurance
BioSpace, Thousand Oaks, California, United States, 91362
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Associate Director Quality Assurance
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BioSpace . 3 weeks ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description
About the role: As the Head of Quality Assurance, you will lead quality oversight to ensure that all products meet applicable regulatory and Takeda quality standards across global markets. You will oversee critical quality systems including batch record review, product release, change control, deviation management, and annual product reviews, while driving compliance with cGMP and regulatory requirements. You will contribute to global and site-level strategic initiatives, support regulatory inspections, and provide direction during quality-impacting incidents. Additionally, this position is accountable for resource and budget management, talent development, and succession planning to support long-term organizational success. You will report to the Site Quality Head. How You Will Contribute
Ensure adequate Quality oversight that meets product requirements across applicable geographies. Maintain adherence to facility quality systems such as batch record review, product release, change control, deviation management, and product annual reviews. Manage resources to meet production and product release cycle times for supply chain demands. Participate on Global Core teams and site strategic projects. Identify and assess quality risks and ensure conformance to Takeda quality policies and government regulations. Support Quality Assurance Programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance. Lead product disposition, including deviation review and disposition of product. Support activities ensuring compliance with quality objectives and regulatory requirements. Manage resources to meet supply chain demands. Support new product introductions. Apply technical skills and knowledge of industry best practices and trends. Set and manage the annual budget. Implement lean concepts to improve cycle times. Work with manufacturing management to ensure cGMP compliance and quality systems. Provide direction during manufacturing incidents affecting quality or compliance. Manage investigations, CAPAs, batch record reviews, product release, change control, requalification, and annual reviews. Collaborate with manufacturing teams to improve quality, solve problems, and increase efficiency. Approve changes to processes, equipment, procedures, and systems. Ensure compliance with regulatory and product license requirements. Support external and regulatory inspections. Work with investigators on quality system and product investigations. Hire, develop, and retain talent; manage performance and plan for future needs. Minimum Requirements/Qualifications
Bachelor's degree in a related field. Minimum 10 years of experience in manufacturing or quality operations in biotech, biologics, or pharmaceutical manufacturing. Minimum 5 years of leadership, supervisory, or management experience. More About Us
At Takeda, we aim to transform patient care through innovative pharmaceuticals and patient support programs. We foster an inclusive, collaborative workplace committed to delivering Better Health and a Brighter Future. Compensation and Benefits
We offer a transparent pay structure, competitive salary range ($153,600 - $241,340), and benefits including health insurance, 401(k), disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being programs. Location
USA - CA - Thousand Oaks - Rancho Conejo Additional Details
Seniority level: Director Employment type: Full-time Job function: Quality Assurance Industries: Biotechnology, Pharmaceuticals This job is active and accepting applications.
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Associate Director Quality Assurance
role at
BioSpace . 3 weeks ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description
About the role: As the Head of Quality Assurance, you will lead quality oversight to ensure that all products meet applicable regulatory and Takeda quality standards across global markets. You will oversee critical quality systems including batch record review, product release, change control, deviation management, and annual product reviews, while driving compliance with cGMP and regulatory requirements. You will contribute to global and site-level strategic initiatives, support regulatory inspections, and provide direction during quality-impacting incidents. Additionally, this position is accountable for resource and budget management, talent development, and succession planning to support long-term organizational success. You will report to the Site Quality Head. How You Will Contribute
Ensure adequate Quality oversight that meets product requirements across applicable geographies. Maintain adherence to facility quality systems such as batch record review, product release, change control, deviation management, and product annual reviews. Manage resources to meet production and product release cycle times for supply chain demands. Participate on Global Core teams and site strategic projects. Identify and assess quality risks and ensure conformance to Takeda quality policies and government regulations. Support Quality Assurance Programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance. Lead product disposition, including deviation review and disposition of product. Support activities ensuring compliance with quality objectives and regulatory requirements. Manage resources to meet supply chain demands. Support new product introductions. Apply technical skills and knowledge of industry best practices and trends. Set and manage the annual budget. Implement lean concepts to improve cycle times. Work with manufacturing management to ensure cGMP compliance and quality systems. Provide direction during manufacturing incidents affecting quality or compliance. Manage investigations, CAPAs, batch record reviews, product release, change control, requalification, and annual reviews. Collaborate with manufacturing teams to improve quality, solve problems, and increase efficiency. Approve changes to processes, equipment, procedures, and systems. Ensure compliance with regulatory and product license requirements. Support external and regulatory inspections. Work with investigators on quality system and product investigations. Hire, develop, and retain talent; manage performance and plan for future needs. Minimum Requirements/Qualifications
Bachelor's degree in a related field. Minimum 10 years of experience in manufacturing or quality operations in biotech, biologics, or pharmaceutical manufacturing. Minimum 5 years of leadership, supervisory, or management experience. More About Us
At Takeda, we aim to transform patient care through innovative pharmaceuticals and patient support programs. We foster an inclusive, collaborative workplace committed to delivering Better Health and a Brighter Future. Compensation and Benefits
We offer a transparent pay structure, competitive salary range ($153,600 - $241,340), and benefits including health insurance, 401(k), disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being programs. Location
USA - CA - Thousand Oaks - Rancho Conejo Additional Details
Seniority level: Director Employment type: Full-time Job function: Quality Assurance Industries: Biotechnology, Pharmaceuticals This job is active and accepting applications.
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