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
- A leading consulting firm located in San Diego is looking for a Quality Assurance Senior Specialist... ...has over 10 years of experience in a GMP environment and possesses excellent... ...collaboration with various departments to maintain audit readiness and quality compliance. #J-18808...Suggested
- ...manage nonconformances, CAPA records, and audits. The role drives quality improvements through... ...assessments. Responsibilities include leading quality meetings, reviewing manufacturing... ...mentoring staff, and coordinating regional QA activities. A BA/BS in a related field with...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- Abzena Inc. is seeking a Quality Assurance Operations Supervisor to lead QA oversight across biologics manufacturing processes including cell culture, fermentation, harvest, purification, and bulk drug substance. You will supervise QA staff on the floor, manage escalations...Suggested
$270k - $290k
...community setting. Our lead product candidate, AlloNK... ...The Executive Director, GMP Quality Assurance leads... ...builds and leads the GMP QA operations organization,... ...inspections and internal audits of internal... ...systems within a growing biotech or biopharmaceutical company...SuggestedFlexible hours- ...searching for a Director of Quality Assurance & Quality Systems to lead and support quality assurance activities for its clinical and... ...with strong leadership capabilities and a deep understanding of GMP and FDA requirements. This position promises an exciting opportunity...
- ...is Deramiocel (CAP‑1002) , our lead cell therapy in late‑stage development... ...the supply chain. Manage Audit Programs: Establish and oversee... ...readiness and compliance with GMP and other regulatory standards.... ...Develop SOPs: Write or revise QA/QC/Supply Chain Standard Operating...
$189k - $246k
...our vision of becoming a leading biopharmaceutical... ...critical Quality Assurance (QA) GMP functions providing... ...Vendor qualification and auditing, Contractor qualificationCollaborate... ...and approve Travere GxP related documents as... ...working experience in Biotech or Pharmaceutical...Contract workTemporary workFor contractorsWork experience placementRemote workShift work- ...operating plans for Clinical QA, and establishing... ...Responsible for building and leading a team of highly trained... ...and clinical audits. Coordinates interdepartmental... ...regulations pertaining to GxP's and current industry trends... ..., as well as GLP and/or GMP systems throughout the...Contract work
- ...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
$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.... ...QC experience in a cell therapy/biotech/pharmaceutical setting is required...Flexible hours- ...Quality Assurance Operations Supervisor to lead on-the-floor QA oversight across biologics production,... ...and change controls to ensure GDP and GxP compliance. You'll partner with... ...to drive continuous improvement, ensure audit readiness, and support client inspections...
$150k - $172k
...physicians can utilize in a community setting. Our lead product candidate, AlloNK, is a non-... ...in cell therapy. As Senior Manager, Clinical QA, you'll lead risk-based GCP oversight across our clinical programs — driving audits, investigations, and inspection readiness that...Contract workFlexible hours- Alliance TrueCare is seeking an LCM Supervisor to oversee daily department workflow, conduct audits, and implement quality improvement plans while ensuring timely access to care and strong customer service. The role includes staff evaluations, onboarding coordination,...Full timeWork at office
$100k - $120k
...Supervisor is responsible for leading Quality oversight... ...Responsibilities Lead hands-on QA collaboration and... ...Good Regulated Practice (GxP) requirements.... ...in client and internal audits as required. Support other... ...manufacturing within a GMP-regulated environment....Local areaShift work- ...a Senior Supplier Quality Specialist to develop and sustain a comprehensive supplier quality program, lead supplier audits, and drive continuous improvement across GMP processes. You will manage SCARs, supplier qualifications, and quality metrics while collaborating with...Work at office
- Artiva Biotherapeutics Inc. in San Diego, CA, seeks an Executive Director of GMP Quality Assurance to lead internal GMP quality operations and ensure compliance with FDA/EMA. You will own QA systems, batch disposition, deviations, CAPA, change control, inspection readiness...
- Artiva Biotherapeutics seeks an Executive Director, GMP Quality Assurance to lead internal GMP quality operations, ensuring cell therapy products meet... .... The successful candidate will build and lead the GMP QA organization, drive risk-based decisions, support BLA readiness...
$45k - $50k
...is seeking a User Experience Quality Assurance Analyst/Coordinator. In this role, you will manage testing processes, collaborate with QA teams, and ensure the highest quality in user-facing applications. You should have a Bachelor's degree in cognitive science or a...- ...compliance, and customer satisfaction while enhancing operational efficiency across the enterprise. You will lead cross-functional quality initiatives, manage audit readiness and regulatory submissions, and develop a high-performing team #J-18808-Ljbffr Mesa Laboratories...
- Maravai LifeSciences is seeking a QA Operations Specialist II to join the Quality Assurance team. This role focuses on maintaining and... ..., and change controls, with alignment to ISO 9001:2015. You will lead cross-functional quality initiatives, review product...
$90k - $110k
...and Regulatory to ensure all documents are accurate, current, and audit-ready. *** This is an in person position in San Diego, CA... ...in Microsoft Office; QMS experience a plus • FDA inspection or GMP audit support experience (NSF, UL, etc.) • Familiarity with CAPA...Work at office- ...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...Full timeContract workWork experience placementWork at officeLocal areaFlexible hours3 days per week
- ...is a global professional services company with leading capabilities in digital, cloud and security. Combining... ...with regulated quality scenarios including GMP and GxP-aligned processes, electronic records expectations, audit readiness, batch genealogy, product release, complaint...Full timeWork experience placementLive inWork at officeLocal areaFlexible hours
$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...Full timeWork at office$240k - $270k
...for all internal and external GxP operations inclusive of clinical... .... This position develops, leads, and coaches the teams responsible... .... Manage a global audit program to ensure vendor/supplier... ...experience in the pharmaceutical or biotech Industry at FDA regulated...Temporary workWork at office- ...meet quality, safety, regulatory, and user requirements. You will lead design controls and coordinate verification/validation across... ...and external regulations. You will guide CAPAs, risk management, audits, and supplier quality, collaborating with product teams to push...
- ...evidence and defect tracking Collaborate with QA and compliance teams to address validation findings... ...and metadata validation Familiarity with Life Sciences compliance standards and GxP environments Exposure to enterprise archival systems and regulatory audit support
$150k - $195k
...our vision of becoming a leading biopharmaceutical... ...for leading and providing GxP Analytical quality/compliance... ...and external Quality audit function, as neededProvide... ...activities as needed.Support QA and Travere Senior... ...required. Direct experience in GMP Quality Assurance,...Full timeContract workTemporary workInterim roleRemote work- ...leadership for the Clinical QA function, ensuring the... ..., as applicable.Lead the planning and execution... ...comprehensive, risk-based GCP audit program (investigator... ...ensure alignment across GxP areas.Foster a culture of... ...in a small, fast-paced biotech environment Excellent communication...Full timeTemporary workLocal areaMonday to Friday
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