Current jobs related to Quality Assurance Compliance Lead - San Diego, California - Capricor Inc
-
Quality Assurance Inspector
2 weeks ago
San Diego, California, United States LEAD Staffing Full timeJob SummaryLEAD Staffing is seeking an experienced Quality Assurance Inspector to join our team in San Diego, CA. As a Quality Assurance Inspector, you will be responsible for conducting in-process and final testing and inspections to ensure compliance with technical requirements for reliability and quality conformance.Key ResponsibilitiesConduct in-process...
-
Quality Assurance Inspector
2 weeks ago
San Diego, California, United States LEAD Staffing Full timeJob SummaryLEAD Staffing is seeking an experienced Quality Assurance Inspector to join our team. As a Quality Assurance Inspector, you will be responsible for conducting in-process and final testing and inspections to ensure compliance with technical requirements for reliability and quality conformance.Key ResponsibilitiesConduct in-process and final testing...
-
Director of Quality Assurance and Compliance
4 weeks ago
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and ComplianceProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a Director of Quality Assurance and Compliance, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing...
-
Director of Quality Assurance and Compliance
1 month ago
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and ComplianceProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing strategic plans...
-
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and Compliance - CRO**About the Role**We are seeking a seasoned professional to lead our Quality Assurance and Compliance team as Director of Quality Assurance and Compliance - CRO. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to...
-
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and Compliance - CROProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing strategic...
-
Director of Quality Assurance and Compliance
2 weeks ago
San Diego, California, United States Sekisui Diagnostics, LLC Full timeAbout the Role:As a Director of Quality Assurance and Compliance at Sekisui Diagnostics, LLC, you will play a critical role in ensuring the quality and integrity of our products. You will oversee the development, implementation, and maintenance of quality assurance systems and activities, including the generation and review of documents used in good...
-
San Diego, California, United States Proven Recruiting Full timeTransformative Leadership OpportunityProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team as Director of Quality Assurance and Compliance. This is a unique chance to drive impactful projects, expand your GLP knowledge, and collaborate with a skilled team.Key Responsibilities:Implement an Electronic Document...
-
Quality Assurance Compliance Specialist
1 month ago
San Diego, California, United States Innovive Full timeJob Title: Quality Assurance Compliance SpecialistInnovive is a rapidly growing B2B manufacturing company serving the biomedical research industry. We value hard work and credit our team for our success. We are seeking a Quality Assurance Compliance Specialist to contribute to our success through collaboration with suppliers and customers, as well as the...
-
San Diego, California, United States Simply Biotech Full timeJob SummarySimply Biotech is seeking an experienced Associate Director of Quality Assurance and Compliance to join our team. This role will be responsible for ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of our operations.Key ResponsibilitiesDevelop and implement strategic plans for quality assurance,...
-
San Diego, California, United States Simply Biotech Full timeJob Title: Associate Director of QA and ComplianceSimply Biotech is seeking an experienced Associate Director of Quality Assurance and Compliance to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of our operations.Key...
-
San Diego, California, United States Proven Recruiting Full timeDynamic Quality Assurance and Compliance RoleAre you a seasoned professional looking for a new challenge? Proven Recruiting is seeking a highly skilled Associate Director of Quality Assurance and Compliance to join our team. This exciting opportunity offers the chance to expand your knowledge, collaborate with a skilled team, and drive impactful projects.Key...
-
Quality Assurance and Compliance Manager
3 weeks ago
San Francisco, California, United States Allbirds Full timeJob Title: Quality Assurance and Compliance ManagerWe are seeking a highly skilled Quality Assurance and Compliance Manager to join our team at Allbirds. As a key member of our Operations team, you will be responsible for leading and elevating our Quality Assurance program to ensure the highest standards of quality and compliance across our products.Key...
-
Quality Assurance and Compliance Manager
6 days ago
San Francisco, California, United States Allbirds Full timeQuality Assurance and Compliance ManagerWe are seeking a proactive, collaborative, and detail-oriented Quality Assurance (QA) and Compliance Manager to lead and elevate the QA program at Allbirds.This key role will oversee the end-to-end quality assurance process-from initial design through product development, manufacturing, and post-purchase analysis.The...
-
Quality Assurance and Compliance Manager
2 weeks ago
San Francisco, California, United States Allbirds Full timeJob Title: Quality Assurance and Compliance ManagerWe are seeking a highly skilled Quality Assurance and Compliance Manager to join our team at Allbirds. As a key member of our Operations team, you will be responsible for overseeing the end-to-end quality assurance process, from initial design through product development, manufacturing, and post-purchase...
-
Quality Assurance Strategist
1 week ago
San Diego, California, United States CorDx Full timeJob DescriptionCorDx is a leading biotech organization dedicated to delivering innovative diagnostic solutions. We are seeking a highly skilled Quality Assurance Strategist to join our team.The successful candidate will be responsible for developing and implementing quality assurance strategies to ensure compliance with FDA, ISO 13485, and other relevant...
-
Quality Assurance and Compliance Manager
1 month ago
San Francisco, California, United States Allbirds Full timeQuality Assurance and Compliance ManagerWe are seeking a highly skilled Quality Assurance and Compliance Manager to join our team at Allbirds. As a key member of our Operations team, you will be responsible for overseeing the end-to-end quality assurance process, from initial design through product development, manufacturing, and post-purchase analysis.Key...
-
Quality Assurance Specialist
2 weeks ago
San Diego, California, United States Johnson Service Group Full timeJob Title: Quality Assurance AnalystJohnson Service Group is seeking a highly skilled Quality Assurance Analyst to join our team. As a Quality Assurance Analyst, you will play a critical role in ensuring the quality and compliance of our medical devices.Key Responsibilities:Assist with quality system supplier audits and ensure compliance with regulatory...
-
Quality Assurance Manager
1 month ago
San Diego, California, United States BD (Becton, Dickinson and Company) Full timeJob DescriptionBD is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality assurance department, you will be responsible for leading complaint investigations and failure analyses to ensure the highest level of quality and safety in our medical devices.Key Responsibilities:Develop and implement complaint...
-
San Mateo, California, United States GILEAD Sciences Full timeJob DescriptionWe are seeking a highly experienced Director, Quality Assurance Compliance/Audit Lead to join our team at Gilead Sciences. This role will report to the Executive Director, Supplier Quality Management and Audits, within the Global Quality Systems & Compliance department.Key Responsibilities:Lead a team of auditors based in North...
Quality Assurance Compliance Lead
2 months ago
Position Title: Quality Compliance Supervisor
We are looking for a detail-oriented and proactive individual who excels in organization and has a passion for enhancing operational processes. The ideal candidate will play a pivotal role in facilitating the launch and production of commercial products, ensuring that quality standards are met and maintained. Key responsibilities encompass the review of batch records, investigation of deviations, issuance and tracking of labels, as well as the management of company-wide GLP / GCP / GMP documentation, training, and facility support systems.
Expertise in standard document control processes and experience within an FDA-regulated setting are essential. This role will report directly to the Associate Director of Quality Assurance.
Key Responsibilities:
- Oversee and assist global teams across two locations with Global Change Control Management and Global Deviation/CAPA Management.
- Ensure readiness for Regulatory Inspections across both sites by developing a comprehensive training program.
- Administer Global document control processes, including the establishment of corporate policies and workflows.
- Oversee the traceability of final drug products across two sites.
- Manage final product specifications for both locations.
- Possess a working knowledge of 21 CFR 210 and 211, 600, ICH, ISO9001, EU Guidelines, and other pertinent FDA regulations.
- Review completed deviations, corrective and preventative actions (CAPA), change controls, training, and internal audits. Prepare associated reports and provide constructive feedback to relevant stakeholders.
- Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including word processing, tracking, issuing, distributing, and archiving, utilizing either manual or electronic document management systems.
- Collaborate on the development and enhancement of quality management systems as assigned.
- Draft and/or review policies, standards, procedures, and work instructions to document quality processes and practices.
- Support regulatory and submission activities as required.
- Prepare relevant materials for Management Review and Material Review Board meetings.
- Perform additional duties as assigned.
Qualifications:
- Bachelor's Degree with a minimum of 5 years of experience in a cGMP environment, including supervisory experience.
- Experience in a commercial cell therapy organization is highly preferred.
- Experience in Aseptic Processing is advantageous.
- Exceptional attention to detail and strong record-keeping abilities.
- Proficient in MS Word, Excel, Visio, Access, Adobe Suite, and database systems.
- Excellent verbal and written communication skills.
- Familiarity with Quality Systems and records management in a cGMP context.
- Strong problem-solving capabilities and the ability to manage multiple tasks effectively.
- Results-driven with a commitment to compliance and customer service.
- Demonstrated initiative, independence, and follow-through.
- Able to thrive in a fast-paced, cross-functional team environment.
- Adaptable to rapidly changing priorities.
Work Environment / Physical Requirements:
- Ability to sit and stand for extended periods.
- Capability to lift and carry materials weighing up to 40 pounds, navigate the office space, communicate effectively, and complete necessary paperwork.
- Willingness to work extended or off-hours as needed to accommodate manufacturing schedules and equipment alarms.
