Biotech QA Lead - GxP & GMP Audits
Torrey Pines Solutions
A biotechnology firm located in San Diego is seeking an experienced Quality Manager to oversee GxP activities and ensure quality compliance. This role involves managing the quality system, conducting audits, and collaborating with internal/external teams. Candidates must have a B.S. or M.S. in sciences and experience in the Biotech/Pharma industry, particularly in quality auditing. Strong analytical and communication skills are essential for this position. #J-18808-Ljbffr Torrey Pines Solutions
- ...in San Diego seeks a Quality professional to provide GMP quality oversight and technical support for CMOs, focusing... ...review quality records, support batch disposition, lead deviation investigations, participate in audits, and collaborate with internal and external partners...Suggested
$68k - $102k
...Quality Assurance professional to ensure compliance with regulatory frameworks and enhance product quality. The candidate will support audits and manage quality projects, interacting with various stakeholders. Required qualifications include a Bachelor's degree in...Suggested- CorVel Corporation is seeking a Claims Quality Assurance expert to conduct audits and ensure compliance with claim handling standards. The role involves training, monitoring performance, and leading quality assurance initiatives. This position is fully remote and requires...SuggestedRemote job
$161k - $180k
...with Good Manufacturing Practice (GMP) standards, regulatory... ...Provide Quality Assurance (QA) oversight of contract manufacturers... ...vendors, including qualification, audits, and tracking of audit observations... ...211, FDA) Proven ability to lead process improvement initiatives...SuggestedContract workTemporary workWork at officeLocal areaRemote workHome officeMonday to ThursdayFlexible hoursNight shift- ...is seeking a Director of Quality Assurance & Quality Systems to lead quality assurance activities for its biotechnology operations. The... ...requires extensive experience in quality assurance within the biotech sector, with a focus on cell and gene therapies. Successful candidates...Suggested
- ...responsibility of this position is to oversee GxP activities and maintain the... ...critical documents and perform the audit internally or externally. Main Job... ...sciences Prior experience as a QA Auditor Auditing experience of GMP quality standards Ability to analyze...Work experience placement
$112k - $150k
...management. The manager will ensure compliance with applicable GxP requirements (GLP, GCP, GMP), FDA and global regulatory expectations, and industry... ...nonconformances CAPA Change control Risk management Audit management Complaint handling (if applicable) Distribute...Temporary work- Sobi is seeking a QA Manager, GCP in the United States to lead quality oversight for GCP/GCLP activities, audits, and risk assessments under a global framework. You will support data collection for audit programs and ensure QA involvement across clinical studies. The role...
- ...2025. As a fast-growing biotech, we offer an entrepreneurial... ...through qualification audits and routine oversight to... ...mastery of global GMP regulations, ICH guidelines... ...Record: Proven capability to lead cross‑functional quality... ...to bridge technical QC/QA data with global...Contract workLocal area
$110k - $135k
...utilize in a community setting. Our lead product candidate, AlloNK, is a... ...teams including Manufacturing, QA, and Regulatory Affairs for... .... Planning and scheduling for GMP in‑process and release testing.... ...experience in a cell therapy/biotech/pharmaceutical setting is required...Flexible hours$30 - $33 per hour
...quality assurance experience in a regulated environment, being detail-oriented and collaborative. The chosen candidate will oversee QA release processes, conduct inspections, and support quality systems. The position is fully on-site, offering an hourly rate between $...Hourly pay$112k - $153k
Swedish Orphan Biovitrum AB (publ) in San Diego is seeking a QA Manager for GCP responsibilities. Key duties include ensuring quality oversight for GCP/GCLP activities and managing audit processes. The ideal candidate has a degree in Life Sciences, 5+ years of experience...$180k - $230k
...molecules and biologics. Arrowhead is leading the field in bringing the promise... ...inspections, work closely with QA to ensure Patient Safety input to GCP, GVP, GMP inspections, support issue reporting... .... Conduct regular internal audits of pharmacovigilance processes, systems...$112k - $153k
Job Description The QA Manager, GCP is responsible for: Ensuring quality oversight and... ...related activities within Sobi, including audits, inspection, and risk assessment of the BLA... ...with procurement, business owners for GxP and quality requirements, and documented qualification...Temporary workLocal areaFlexible hours- ...& Quality Program Leadership Lead and maintain SQF, FSMA, HACCP,... ...routine internal validations and audits. Maintain certifications including... ...bodies, and customer QA teams to ensure audit readiness... ...preferred). Strong knowledge of GMP, HACCP, FSMA, SQF, USDA/FDA regulatory...Full timeWork at officeLocal areaWeekend work
$175k - $215k
...innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage... ...ideal candidate brings hands-on QA and Quality Systems experience, deep knowledge of GMP and FDA requirements, and a proven... ...and execution of internal audits, including regulatory inspections...Work at office- ...generate and maintain final NDT reports, traceability records, audit trails and certification logs. Maintain complete, accurate and organized... ...with Veridiam’s markets: aerospace/space, nuclear, medical.) Lead investigations of NDT non‑conformances, root‑cause analysis,...Permanent employment
- ...in San Diego to oversee the quality assurance function, ensuring both incoming and outgoing product quality. In this role, you will lead a small team, maintain technical quality control systems, and actively participate in continuous improvement initiatives. Qualified...
$214k - $292k
...Director Quality Assurance will lead Gene Therapy QA oversight for product... ...will ensure phase-appropriate GMP compliance across manufacturing... ...organizations (CDMOs), and other GxP vendors used for clinical... ...Agreements, risk assessments, audits, and vendor qualification activities...Contract workWork at officeLocal areaFlexible hours3 days per week- ...batch record review and supplier management, ensuring compliance with quality systems. Candidates should have at least 2-3 years of QA experience preferably in the pharmaceutical industry and be familiar with regulations and document management systems. The position entails...
$120k - $150k
Abzena Inc. is seeking a QC Stability Manager in San Diego, California to lead and support GMP large-molecule stability testing across all phases of client programs within QC. This role requires strong experience in QC laboratory operations and stability program management...- ...evidence and defect tracking Collaborate with QA and compliance teams to address validation findings... ...with Life Sciences compliance standards and GxP environments Exposure to enterprise archival systems and regulatory audit support #J-18808-Ljbffr Creative Solutions...
$83k - $114k
...PRINCIPAL DUTIES/RESPONSIBILITIES: Enforcing an effective QA program that meets all the requirements of the Delphinus... ...utilization of precision measuring devices. Conduct internal audits/surveillances to ensure adherence to company procedures/policies....Temporary workWork at office- ...execute cyclical, wall-to-wall, and spot inventories to maintain audit readiness and data integrity. Conduct quality control... .... Effective written and verbal communication skills. Ability to lead by influence and collaborate with site leadership and warehouse...
- ...Manage quality activities, including planning and monitoring technical performance, to ensure quality and financial objectives are met Lead and maintain the quality management system in compliance with AS9100 and applicable federal/state regulations Prepare and present...Permanent employment
$140k - $160k
...department/team performance, and market factors. At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held...Work at officeRemote workRelocation package$130k - $170k
...customer quality standards. This role involves developing and implementing quality control systems, monitoring production processes, and leading continuous improvement initiatives to enhance product quality and operational efficiency. Key Responsibilities Lead and manage a...Full timeAll shifts- ...Worth is now looking for a Head of Quality Assurance to build, lead, and elevate our QA function across the organization. This role is both strategic and hands-on. You will define quality standards, build scalable testing processes, and lead a team of QA engineers — while...Contract workRemote workFlexible hours
$134k - $186k
...identify trends, systemic issues, and improvement opportunities, and lead cross-functional teams in developing and implementing effective... ...are fully compliant, and effectively managing external audits, inspections, and follow-up actions. • Leads and manages complex...Full timeWork at officeLocal areaRemote workWork visaRelocation package3 days per week$120k - $140k
A prominent accounting firm is looking for an Assurance Manager in San Diego, CA. This role will involve supervising audit teams, advising clients on accounting issues, and ensuring compliance with professional standards. The ideal candidate will have a strong background...
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