Director, Quality Systems and Compliance
This position is responsible for maintaining and improve compliance to applicable regulatory requirements by maintaining an effective quality management system.
The ideal candidate will be primary responsibility for the continuous improvement of Rani quality systems for record management, change control, training, auditing, supplier management, inspection readiness, quality metrics tracking and reporting.
This individual works closely with all different functions/departments at Rani to ensure adherence to Rani policies as well as to applicable regulatory requirements.
Major Duties and ResponsibilitiesMaintain and improve the quality system and provide compliance oversight per FDA 21 CFR part 4, 820, 210, 211, and ISO 13485 requirementsLead and manage the sites ISO 13485 certification programWrite, revise QA Policies, Standard Operating Procedures, as applicableManagement of Training Program in compliance with cGMP for drugs and combination product standardsOversee and maintain the deviation, CAPA, change control, training, product complain, investigation and non-conformance and risk management programs to ensure compliance with internal SOP and regulatory authority requirementsCreate and establish the annual internal audit programTrend and report quality metrics for Management Reviews.
Ensures that performance and quality of products conform to established standards and regulatory agency requirementsReview regulatory requirements documents and provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued complianceImplement quality system changes to support evolving regulations and international standardsParticipate in regulatory authority inspectionsLead/coordinate investigations, and the development and implementation of corrective and preventative action (CAPA)Work extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basisManage and trend product complaintsManage supplier qualification program and establish supplier qualification processes, audit plans, quality agreements, quality performance metrics and perform GMP audits to suppliers and service providersSupport the organization in maintaining a work environment focused on quality that fosters learning, respect, open communication, collaboration, integration, and teamworkEnsure an understanding of the external regulatory requirements, in order to adapt product quality strategy accordinglyEducation and/or Job Experience10
years of relevant experience in the pharmaceutical or biotechnology industry, and a Bachelor's degree in science or related fieldsStrong knowledge of cGMP requirements including 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO)Experience with Quality System Regulation 21 CFR 820 and ISO 13485:
2016 Quality Management SystemPrevious experience with combination products is requiredMust be familiar with:
cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal/external cGMPs, GLPStrong knowledge of medical devices, combination products and general pharmaceutical manufacturingStrong project management and process improvement skillsDemonstrate keen understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiativesExperience with Risk Management principles according to ISO 14971 and ICH Q9Prior people management experienceExcellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organizationMust demonstrate ability to work independently, make effective decisionsSkills and SpecificationsAttention to detail and organizational skillsGood interpersonal and communication skillsAbility to work as a part of a teamAbility to multi-task and manage a diverse mix of issues, responsibilities and challengesFlexible and adaptable to changing environment and prioritiesSalary Range:
$200,000 - $252,069Rani Therapeutics LLC is an equal opportunity employer.
This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Our organization's commitment to Diversity, Equity, and Inclusion is key to making us a better team - one that makes better decisions, drives innovation, and delivers better business results.
At Rani Therapeutics, we're committed to a workplace culture where everyone feels comfortable to bring their authentic selves.
We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions.
We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
San Jose, CA /Quality QA Team /Full Time/ On-site.
Estimated Salary: $20 to $28 per hour based on qualifications.
The ideal candidate will be primary responsibility for the continuous improvement of Rani quality systems for record management, change control, training, auditing, supplier management, inspection readiness, quality metrics tracking and reporting.
This individual works closely with all different functions/departments at Rani to ensure adherence to Rani policies as well as to applicable regulatory requirements.
Major Duties and ResponsibilitiesMaintain and improve the quality system and provide compliance oversight per FDA 21 CFR part 4, 820, 210, 211, and ISO 13485 requirementsLead and manage the sites ISO 13485 certification programWrite, revise QA Policies, Standard Operating Procedures, as applicableManagement of Training Program in compliance with cGMP for drugs and combination product standardsOversee and maintain the deviation, CAPA, change control, training, product complain, investigation and non-conformance and risk management programs to ensure compliance with internal SOP and regulatory authority requirementsCreate and establish the annual internal audit programTrend and report quality metrics for Management Reviews.
Ensures that performance and quality of products conform to established standards and regulatory agency requirementsReview regulatory requirements documents and provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued complianceImplement quality system changes to support evolving regulations and international standardsParticipate in regulatory authority inspectionsLead/coordinate investigations, and the development and implementation of corrective and preventative action (CAPA)Work extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basisManage and trend product complaintsManage supplier qualification program and establish supplier qualification processes, audit plans, quality agreements, quality performance metrics and perform GMP audits to suppliers and service providersSupport the organization in maintaining a work environment focused on quality that fosters learning, respect, open communication, collaboration, integration, and teamworkEnsure an understanding of the external regulatory requirements, in order to adapt product quality strategy accordinglyEducation and/or Job Experience10
years of relevant experience in the pharmaceutical or biotechnology industry, and a Bachelor's degree in science or related fieldsStrong knowledge of cGMP requirements including 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO)Experience with Quality System Regulation 21 CFR 820 and ISO 13485:
2016 Quality Management SystemPrevious experience with combination products is requiredMust be familiar with:
cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal/external cGMPs, GLPStrong knowledge of medical devices, combination products and general pharmaceutical manufacturingStrong project management and process improvement skillsDemonstrate keen understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiativesExperience with Risk Management principles according to ISO 14971 and ICH Q9Prior people management experienceExcellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organizationMust demonstrate ability to work independently, make effective decisionsSkills and SpecificationsAttention to detail and organizational skillsGood interpersonal and communication skillsAbility to work as a part of a teamAbility to multi-task and manage a diverse mix of issues, responsibilities and challengesFlexible and adaptable to changing environment and prioritiesSalary Range:
$200,000 - $252,069Rani Therapeutics LLC is an equal opportunity employer.
This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Our organization's commitment to Diversity, Equity, and Inclusion is key to making us a better team - one that makes better decisions, drives innovation, and delivers better business results.
At Rani Therapeutics, we're committed to a workplace culture where everyone feels comfortable to bring their authentic selves.
We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions.
We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
San Jose, CA /Quality QA Team /Full Time/ On-site.
Estimated Salary: $20 to $28 per hour based on qualifications.
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