Blackwomenintech
Quality Assurance (QA) Senior Specialist - Large Molecule Analytical
Blackwomenintech, Rahway, New Jersey, us, 07065
Job DescriptionPosition Description:Quality Assurance
(QA) Senior Specialist - Large Molecule AnalyticalWe are seeking a quality leader for the role of Senior Specialist, Quality Assurance in the Large Molecule Analytical Sciences Quality group.Large Molecule Analytical Sciences Quality is part of the Global Biologics Quality Organization and is responsible for technical, operational and strategic quality oversight of a growing and fast-moving large molecule pipeline. LMAS Quality is specifically focused on quality oversight for large molecule drug substance commercial support, Analytical Method Transfers, and analytical product lifecycle activities.This position is responsible for the management, execution and leadership of quality activities to further the analytical product lifecycle of large molecule programs and to ensure compliance with cGMPs, applicable worldwide regulations, and our Company's requirements for supported area(s).The Senior Specialist is also responsible for providing assessments to senior management as to the compliance status and risk posture of supported area(s) and guidance on alignment of policies and procedures with current regulatory expectations.Responsibilities include but are not limited to:Remain informed of current GMP requirements and industry trends in the large molecule, analytical areas to applicable worldwide regulations and industry standards. Provide comments on proposed regulations and communicate impacts to client areas using a risk-based, phase-appropriate approach for decision making. Maintain an expert level of knowledge related to specialized area of technical expertise, specifically for analytical areas.Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensure periodic updates, as appropriate.Manage the review and/or approval of analytical GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer.Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within our Company.Support a team of professionals to execute on quality oversight deliverables for large molecule drug substance analytical product lifecycle.Apply technical / quality expertise to help teams remove obstacles, overcome technical challenges, and make impactful clinical disposition decisions.Review and approve analytical documents.Collaborate with peer leaders in LMAS Quality Assurance to drive strategic initiatives and continuous improvement opportunities.Contribute to establishment and sustainability of a safety first, compliance always culture.Primary skills include but are not limited to:Strong scientific/technical expertise in the commercial space, coupled with the ability to collaborate with subject matter experts.Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within a commercial environment.Possess and apply large molecule drug substance technical knowledge (such as analytical method / development / transfer); demonstrated ability to share knowledge.Ability to support cross-functional analytical initiatives.Demonstrated experience with quality risk management.Strong cross-functional teamwork and collaboration skills.Demonstrated ability to communicate (oral and written) effectively with diverse individuals / groups.Position Qualifications:Education Minimum Requirement:Bachelor Degree in Engineering, Biology, Chemistry or related field.Required Experience and Skills:A minimum of 8+ years of relevant experience working within the biologics and/or vaccines / pharmaceutical industry or advanced Degree with 5+ years of relevant experience.Employee Status:
RegularRelocation:
NoVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayJob Posting End Date:
10/8/2024Requisition ID:
R314897
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(QA) Senior Specialist - Large Molecule AnalyticalWe are seeking a quality leader for the role of Senior Specialist, Quality Assurance in the Large Molecule Analytical Sciences Quality group.Large Molecule Analytical Sciences Quality is part of the Global Biologics Quality Organization and is responsible for technical, operational and strategic quality oversight of a growing and fast-moving large molecule pipeline. LMAS Quality is specifically focused on quality oversight for large molecule drug substance commercial support, Analytical Method Transfers, and analytical product lifecycle activities.This position is responsible for the management, execution and leadership of quality activities to further the analytical product lifecycle of large molecule programs and to ensure compliance with cGMPs, applicable worldwide regulations, and our Company's requirements for supported area(s).The Senior Specialist is also responsible for providing assessments to senior management as to the compliance status and risk posture of supported area(s) and guidance on alignment of policies and procedures with current regulatory expectations.Responsibilities include but are not limited to:Remain informed of current GMP requirements and industry trends in the large molecule, analytical areas to applicable worldwide regulations and industry standards. Provide comments on proposed regulations and communicate impacts to client areas using a risk-based, phase-appropriate approach for decision making. Maintain an expert level of knowledge related to specialized area of technical expertise, specifically for analytical areas.Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensure periodic updates, as appropriate.Manage the review and/or approval of analytical GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer.Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within our Company.Support a team of professionals to execute on quality oversight deliverables for large molecule drug substance analytical product lifecycle.Apply technical / quality expertise to help teams remove obstacles, overcome technical challenges, and make impactful clinical disposition decisions.Review and approve analytical documents.Collaborate with peer leaders in LMAS Quality Assurance to drive strategic initiatives and continuous improvement opportunities.Contribute to establishment and sustainability of a safety first, compliance always culture.Primary skills include but are not limited to:Strong scientific/technical expertise in the commercial space, coupled with the ability to collaborate with subject matter experts.Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within a commercial environment.Possess and apply large molecule drug substance technical knowledge (such as analytical method / development / transfer); demonstrated ability to share knowledge.Ability to support cross-functional analytical initiatives.Demonstrated experience with quality risk management.Strong cross-functional teamwork and collaboration skills.Demonstrated ability to communicate (oral and written) effectively with diverse individuals / groups.Position Qualifications:Education Minimum Requirement:Bachelor Degree in Engineering, Biology, Chemistry or related field.Required Experience and Skills:A minimum of 8+ years of relevant experience working within the biologics and/or vaccines / pharmaceutical industry or advanced Degree with 5+ years of relevant experience.Employee Status:
RegularRelocation:
NoVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayJob Posting End Date:
10/8/2024Requisition ID:
R314897
#J-18808-Ljbffr