Quality Enterprises USA
Head of Quality
Quality Enterprises USA, Carlsbad, California, United States, 92002
This position is responsible for leading the Quality team ensuring compliant process, team management, and oversight of the Quality compliance and Quality operations in support of EU, FDA, Clinical Trial, CLIA/CAP, state and ISO compliance requirements. Responsibilities include the management of personnel and compliance for assay validation, clinical study development and testing, IVD manufacturing, and overall Quality Systems (change control, CAPA, equipment, computerized systems, etc.).About the Role
Major accountabilities:Works in a GCP/CLIA/GCLP/IVD GMP regulated environment and is responsible for oversight of all applicable regulations.Implement and maintain quality metrics, systems and documentation associated with clinical trials, including, but not limited to procedures, processes, tests, equipment, materials, regulatory requirements, and staffing proficiency.Develop and conduct GxP, CLIA, IVD Manufacturing, and GCLP training across all lab areas to ensure compliance to regulatory requirements.Manage, create and ensure appropriateness of procedures related to Clinical Trials and IVDs. Provide quality and regulatory assessment for laboratory policies and procedures.Serve as quality liaison with regulatory agencies and sponsors.Maintain appropriate state licenses for a CLIA medical laboratory and CAP and ISO accreditations.Manage staff to ensure timely deliverance of assigned responsibilities including product release, IVD design control and manufacturing, and compliance including that of partner laboratoriesProvide quality assessment for assay/product validationsEstablish and maintain Quality Systems to meet regulatory requirements, including IVD GMP, GCP, CLIA, and CAP.Oversee, host and/or lead regulatory, sponsor, external vendor and/or partner lab inspections/audits, and perform related internal GMP, GCLP and CLIA Regulatory Compliance Audits. Work with internal departments as needed to identify and resolve / complete corrective actions. Assist with other internal audits as needed.Identify, design and implement opportunities for improvement across all areas of responsibility.Develop metrics, reports, charts and/or related documentation as needed for Quality Management ReviewEnsure complete and compliant documentation in support of internal auditing, change control, and incident managementKey performance indicators:Provide successful strategic and managerial leadership for Navigate in all Quality related matters and ensure that all aspects of the operational business comply with applicable compliance and regulatory requirements.Successful oversight of Navigate's Quality Management System; Perform leadership and strategic responsibilities related to company objectives and changing regulatory requirements.Successful Quality partnership internally with all stakeholders, and externally with all Sponsors and Regulatory agencies.Successful oversight of all inspections/audits, management of deviations and incidents, and maintenance of applicable permits and licenses.Minimum of twelve (12) years progressively responsible experience in a related Quality Assurance role in a regulated environment, preferably GCP.Minimum of seven (7) years specifically related experience with clinical trials supporting GCLPMinimum of five (5) years with leadership and direct supervisory experienceSkills:Detail and goal oriented with ability to manage multiple projects at one timePeople leadership across all areas of QualityAbility to contribute to Navigate leadership and partner with other leadersStrong agility, collaboration, and teamworkClear understanding of Clinical Labs in support of drug development clinical trials (GCP / GCLP / CLIA)Strong experience in managing and hosting Sponsor and Regulatory auditsStrong experience managing internal auditing for GCP studies (study monitoring)Decision making skills understanding risk, operational practices, and complianceTeam development and leadershipLanguages :Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkThe Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.Accessibility & Reasonable AccommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com
or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Division
OperationsBusiness Unit
Innovative MedicinesLocation
USASite
CarlsbadCompany / Legal Entity
U441 (FCRS = US441) Navigate BioPharma Services, Inc.Manage Consent Preferences
Always ActiveIf you provided your email for marketing or disease awareness purposes, you may need to provide further information to enable us to fully honor your preferences. Click here
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Major accountabilities:Works in a GCP/CLIA/GCLP/IVD GMP regulated environment and is responsible for oversight of all applicable regulations.Implement and maintain quality metrics, systems and documentation associated with clinical trials, including, but not limited to procedures, processes, tests, equipment, materials, regulatory requirements, and staffing proficiency.Develop and conduct GxP, CLIA, IVD Manufacturing, and GCLP training across all lab areas to ensure compliance to regulatory requirements.Manage, create and ensure appropriateness of procedures related to Clinical Trials and IVDs. Provide quality and regulatory assessment for laboratory policies and procedures.Serve as quality liaison with regulatory agencies and sponsors.Maintain appropriate state licenses for a CLIA medical laboratory and CAP and ISO accreditations.Manage staff to ensure timely deliverance of assigned responsibilities including product release, IVD design control and manufacturing, and compliance including that of partner laboratoriesProvide quality assessment for assay/product validationsEstablish and maintain Quality Systems to meet regulatory requirements, including IVD GMP, GCP, CLIA, and CAP.Oversee, host and/or lead regulatory, sponsor, external vendor and/or partner lab inspections/audits, and perform related internal GMP, GCLP and CLIA Regulatory Compliance Audits. Work with internal departments as needed to identify and resolve / complete corrective actions. Assist with other internal audits as needed.Identify, design and implement opportunities for improvement across all areas of responsibility.Develop metrics, reports, charts and/or related documentation as needed for Quality Management ReviewEnsure complete and compliant documentation in support of internal auditing, change control, and incident managementKey performance indicators:Provide successful strategic and managerial leadership for Navigate in all Quality related matters and ensure that all aspects of the operational business comply with applicable compliance and regulatory requirements.Successful oversight of Navigate's Quality Management System; Perform leadership and strategic responsibilities related to company objectives and changing regulatory requirements.Successful Quality partnership internally with all stakeholders, and externally with all Sponsors and Regulatory agencies.Successful oversight of all inspections/audits, management of deviations and incidents, and maintenance of applicable permits and licenses.Minimum of twelve (12) years progressively responsible experience in a related Quality Assurance role in a regulated environment, preferably GCP.Minimum of seven (7) years specifically related experience with clinical trials supporting GCLPMinimum of five (5) years with leadership and direct supervisory experienceSkills:Detail and goal oriented with ability to manage multiple projects at one timePeople leadership across all areas of QualityAbility to contribute to Navigate leadership and partner with other leadersStrong agility, collaboration, and teamworkClear understanding of Clinical Labs in support of drug development clinical trials (GCP / GCLP / CLIA)Strong experience in managing and hosting Sponsor and Regulatory auditsStrong experience managing internal auditing for GCP studies (study monitoring)Decision making skills understanding risk, operational practices, and complianceTeam development and leadershipLanguages :Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkThe Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.Accessibility & Reasonable AccommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com
or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Division
OperationsBusiness Unit
Innovative MedicinesLocation
USASite
CarlsbadCompany / Legal Entity
U441 (FCRS = US441) Navigate BioPharma Services, Inc.Manage Consent Preferences
Always ActiveIf you provided your email for marketing or disease awareness purposes, you may need to provide further information to enable us to fully honor your preferences. Click here
to learn more.
#J-18808-Ljbffr