Katalyst CRO
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Senior Quality Manager
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Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the
Senior Quality Manager
role at
Katalyst CRO Manage daily quality oversight of 3PL providers and ensure compliance with regulatory expectations. Maintain and support the Quality Management System (QMS) for distribution operations. Prepare and maintain Quality Agreements. Handle deviations, CAPAs, change controls, and related documentation. Conduct risk assessments and recommend mitigation strategies. Maintain KPIs and support Management Review processes. Support regulatory inspections, including planning, hosting, and follow-up CAPAs. Collaborate cross-functionally with internal stakeholders and external partners. Review and approve SOPs and other Quality documentation. Support product complaint handling and ensure suppliers are appropriately approved. Oversee licensing activities and mock recall preparedness.
Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.
Responsibilities
Manage daily quality oversight of 3PL providers and ensure compliance with regulatory expectations. Maintain and support the Quality Management System (QMS) for distribution operations. Prepare and maintain Quality Agreements. Handle deviations, CAPAs, change controls, and related documentation. Conduct risk assessments and recommend mitigation strategies. Maintain KPIs and support Management Review processes. Support regulatory inspections, including planning, hosting, and follow-up CAPAs. Collaborate cross-functionally with internal stakeholders and external partners. Review and approve SOPs and other Quality documentation. Support product complaint handling and ensure suppliers are appropriately approved. Oversee licensing activities and mock recall preparedness.
Requirements:
Bachelor's degree in a scientific or allied health field. 5+ years of experience in Quality roles within pharmaceutical or life sciences. In-depth understanding of GDP and GMP compliance standards. Strong communication, organizational, and problem-solving skills. Proficiency in Microsoft Office (Word, Excel, PowerPoint). Auditing experience and qualifications are a plus. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesBiotechnology Research and Business Consulting and Services Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Quality Assurance Manager” roles.Manager, Quality Assurance (QA), Global QMSSr. Manager, Risk-Based Quality ManagementSr. Director Global Quality Assurance (GLP/GCP) Boston, MA $132,900.00-$199,400.00 6 days ago Senior Manager/Associate Director, Quality Boston, MA $132,900.00-$199,400.00 5 days ago Westwood, MA $80,000.00-$85,000.00 3 weeks ago Marlborough, MA $120,000.00-$199,000.00 1 week ago Senior Director, GCP/GVP Quality Assurance Boston, MA $260,000.00-$275,000.00 2 weeks ago Senior Director, GCP/GVP Quality Assurance Cambridge, MA $260,000.00-$275,000.00 2 weeks ago Deputy Director for Design Quality Assurance Boston, MA $115,900.00-$173,800.00 2 weeks ago Quality Assurance Senior Manager, Technical Life Cycle Management (Cell and Genetic Therapies)Sr. Manager, Risk-Based Quality ManagementQuality Manager - New Product Development Woburn, MA $120,000.00-$140,000.00 1 day ago Mansfield, MA $115,900.00-$173,800.00 18 hours ago Quality Assurance Specialist/Manager – Bioanalytical Laboratory Canton, MA $70,000.00-$90,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Senior Quality Manager
role at
Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the
Senior Quality Manager
role at
Katalyst CRO Manage daily quality oversight of 3PL providers and ensure compliance with regulatory expectations. Maintain and support the Quality Management System (QMS) for distribution operations. Prepare and maintain Quality Agreements. Handle deviations, CAPAs, change controls, and related documentation. Conduct risk assessments and recommend mitigation strategies. Maintain KPIs and support Management Review processes. Support regulatory inspections, including planning, hosting, and follow-up CAPAs. Collaborate cross-functionally with internal stakeholders and external partners. Review and approve SOPs and other Quality documentation. Support product complaint handling and ensure suppliers are appropriately approved. Oversee licensing activities and mock recall preparedness.
Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.
Responsibilities
Manage daily quality oversight of 3PL providers and ensure compliance with regulatory expectations. Maintain and support the Quality Management System (QMS) for distribution operations. Prepare and maintain Quality Agreements. Handle deviations, CAPAs, change controls, and related documentation. Conduct risk assessments and recommend mitigation strategies. Maintain KPIs and support Management Review processes. Support regulatory inspections, including planning, hosting, and follow-up CAPAs. Collaborate cross-functionally with internal stakeholders and external partners. Review and approve SOPs and other Quality documentation. Support product complaint handling and ensure suppliers are appropriately approved. Oversee licensing activities and mock recall preparedness.
Requirements:
Bachelor's degree in a scientific or allied health field. 5+ years of experience in Quality roles within pharmaceutical or life sciences. In-depth understanding of GDP and GMP compliance standards. Strong communication, organizational, and problem-solving skills. Proficiency in Microsoft Office (Word, Excel, PowerPoint). Auditing experience and qualifications are a plus. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesBiotechnology Research and Business Consulting and Services Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Quality Assurance Manager” roles.Manager, Quality Assurance (QA), Global QMSSr. Manager, Risk-Based Quality ManagementSr. Director Global Quality Assurance (GLP/GCP) Boston, MA $132,900.00-$199,400.00 6 days ago Senior Manager/Associate Director, Quality Boston, MA $132,900.00-$199,400.00 5 days ago Westwood, MA $80,000.00-$85,000.00 3 weeks ago Marlborough, MA $120,000.00-$199,000.00 1 week ago Senior Director, GCP/GVP Quality Assurance Boston, MA $260,000.00-$275,000.00 2 weeks ago Senior Director, GCP/GVP Quality Assurance Cambridge, MA $260,000.00-$275,000.00 2 weeks ago Deputy Director for Design Quality Assurance Boston, MA $115,900.00-$173,800.00 2 weeks ago Quality Assurance Senior Manager, Technical Life Cycle Management (Cell and Genetic Therapies)Sr. Manager, Risk-Based Quality ManagementQuality Manager - New Product Development Woburn, MA $120,000.00-$140,000.00 1 day ago Mansfield, MA $115,900.00-$173,800.00 18 hours ago Quality Assurance Specialist/Manager – Bioanalytical Laboratory Canton, MA $70,000.00-$90,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr