AmplifyBio
Manager, QA Compliance Supplier Quality
AmplifyBio, New Albany, Ohio, United States, 43054
Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join
AmplifyBio !AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.The
Amplify
Bio
ecosystem is comprised of three distinct business units:
ADOC
(South San Francisco, CA)– Amplify's Discovery, Optimization, and Characterization laboratories:
ASET
(West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened
AMEC
(New Albany, OH) – Amplify's Manufacturing Enablement Center.About AMEC New Albany, OH:
Amplify
Bio’s
Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a “hoteling model,” traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.Amplify
Bio
is seeking to hire a
Manager
,
QA Compliance – Supplier Quality
to join our growing team!!!The
Manager, QA Compliance – Supplier Quality
is responsible for the management and the execution of the Suppler Quality Management (SQM) and Audit Programs for the New Albany GMP facility. This role will ensure supplier qualifications, external and internal audits are performed in a timely manner to meet quality and business objectives. The ideal candidate will be a hands-on leader with experience building and maintaining supplier quality and raw material programs in GMP regulated environments.What You’ll Do Here:Develop and/or enhance existing procedures for: the selection and management of GMP suppliers, qualification of raw materials (with QC Bioanalytics), and the execution of the audit program (internal, external and client audits).Maintain GMP vendor files, Approved Supplier List (ASL) and conduct periodic assessment to ensure all vendor certification documents, licenses, and statements are current.Draft quality technical agreements as required.Co-manage the Material Review Board with QA Ops leadership.Manage the supplier and internal audit schedule, generate audit plans and conduct routine quality audits of GMP suppliers / service providers and internal QMS.Maintain all audit reports, audit responses, and pertinent corrective actions up to date.Conduct follow-ups for internal and supplier audits corrective actions to ensure closure.Support QA Operations team to investigate product quality complaints, quality events, incidents and CAPAs associated with materials or supplier services.Develop and report KPIs for SQM and the audit program, assist Supply Chain with KPIs related to material qualification and release.Work with QA Training Admin to expand and perform site training for the supplier and audit programs to ensure process alignment.We Would Love to Hear from You If:A bachelor’s degree or higher in a relevant scientific discipline – Bioinformatics, Biology, Biochemistry, Chemistry or equivalent education and experience.A minimum 6 years of experience in Quality within a GxP biotechnology or pharmaceutical environment.Must have documented experience with Supplier Quality Management and Internal/External Auditing. SQM and/or CQA certifications are a plus.Ability to apply GMP regulation and guidelines related to supplier management, such as, 21 CFR Part 210 and 211.Ability to work with minimal supervision.Experience managing a team of direct reports.Strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.Ability to apply a risk-based approach related to this role.At
AmplifyBio , we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.AmplifyBio
is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.Why You Will Love Working Here:We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.Health, Dental, and Vision insurance that starts on your first day at
Amplify
Bio !Competitive Compensation PackageWe take work-life balance seriously and we back it up with a FLEXIBLE PTO policy.Generous paid parental leaveWellness and Self-Care Programs401(k) matchTuition ReimbursementEAP/work-life support systemA fun work environment where everyone’s voice matters.We are just getting started! More benefits on the way!An Opportunity to Change the World!!!When you join our team , you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for
AmplifyBio
is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.
PIb9c8168b08b0-35216-35209140
AmplifyBio !AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.The
Amplify
Bio
ecosystem is comprised of three distinct business units:
ADOC
(South San Francisco, CA)– Amplify's Discovery, Optimization, and Characterization laboratories:
ASET
(West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened
AMEC
(New Albany, OH) – Amplify's Manufacturing Enablement Center.About AMEC New Albany, OH:
Amplify
Bio’s
Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a “hoteling model,” traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.Amplify
Bio
is seeking to hire a
Manager
,
QA Compliance – Supplier Quality
to join our growing team!!!The
Manager, QA Compliance – Supplier Quality
is responsible for the management and the execution of the Suppler Quality Management (SQM) and Audit Programs for the New Albany GMP facility. This role will ensure supplier qualifications, external and internal audits are performed in a timely manner to meet quality and business objectives. The ideal candidate will be a hands-on leader with experience building and maintaining supplier quality and raw material programs in GMP regulated environments.What You’ll Do Here:Develop and/or enhance existing procedures for: the selection and management of GMP suppliers, qualification of raw materials (with QC Bioanalytics), and the execution of the audit program (internal, external and client audits).Maintain GMP vendor files, Approved Supplier List (ASL) and conduct periodic assessment to ensure all vendor certification documents, licenses, and statements are current.Draft quality technical agreements as required.Co-manage the Material Review Board with QA Ops leadership.Manage the supplier and internal audit schedule, generate audit plans and conduct routine quality audits of GMP suppliers / service providers and internal QMS.Maintain all audit reports, audit responses, and pertinent corrective actions up to date.Conduct follow-ups for internal and supplier audits corrective actions to ensure closure.Support QA Operations team to investigate product quality complaints, quality events, incidents and CAPAs associated with materials or supplier services.Develop and report KPIs for SQM and the audit program, assist Supply Chain with KPIs related to material qualification and release.Work with QA Training Admin to expand and perform site training for the supplier and audit programs to ensure process alignment.We Would Love to Hear from You If:A bachelor’s degree or higher in a relevant scientific discipline – Bioinformatics, Biology, Biochemistry, Chemistry or equivalent education and experience.A minimum 6 years of experience in Quality within a GxP biotechnology or pharmaceutical environment.Must have documented experience with Supplier Quality Management and Internal/External Auditing. SQM and/or CQA certifications are a plus.Ability to apply GMP regulation and guidelines related to supplier management, such as, 21 CFR Part 210 and 211.Ability to work with minimal supervision.Experience managing a team of direct reports.Strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.Ability to apply a risk-based approach related to this role.At
AmplifyBio , we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.AmplifyBio
is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.Why You Will Love Working Here:We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.Health, Dental, and Vision insurance that starts on your first day at
Amplify
Bio !Competitive Compensation PackageWe take work-life balance seriously and we back it up with a FLEXIBLE PTO policy.Generous paid parental leaveWellness and Self-Care Programs401(k) matchTuition ReimbursementEAP/work-life support systemA fun work environment where everyone’s voice matters.We are just getting started! More benefits on the way!An Opportunity to Change the World!!!When you join our team , you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for
AmplifyBio
is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.
PIb9c8168b08b0-35216-35209140