Senior QA Specialist - cGMP Compliance & Ops
Oxford Biomedica
Oxford Biomedica in Durham, North Carolina is seeking a Quality Assurance Senior Specialist to oversee operations in an FDA-approved clinical cGMP manufacturing facility. This role is critical in ensuring compliance and advancing our mission of delivering life-changing therapies. The ideal candidate will have a strong background in quality assurance, with over 7 years of experience in the pharmaceutical industry, including 3 years in Quality management. Key responsibilities include documenting compliance, managing quality events, and preparing for inspections. #J-18808-Ljbffr Oxford Biomedica
- KBI Biopharma in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. This role includes reviewing... ...in a QA/QC environment. Strong understanding of FDA and cGMP regulations is required. #J-18808-Ljbffr KBI BiopharmaSenior
$138.6k - $257.4k
Job Description Summary The Head, QA Ops and Compliance (Associate Director Level) provides strategic and hands on leadership for Quality Assurance... ...Small Molecule Operations division, ensuring excellence in cGMP compliance, regulatory execution, and quality oversight...SuggestedRemote work- Sonara Inc. is seeking a Senior QA Manufacturing Specialist in Durham, NC to ensure compliance with quality standards in drug substance manufacturing. You will review executed records and support compliance with regulatory audits. The ideal candidate has a BS/BA in a scientific...Suggested
$113k - $156k
KBI Biopharma Inc. in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. You will provide QA... ...of experience or a Master’s with 6+ years in a QA or cGMP environment. Salary ranges from $113,000 to $156,000, reflecting...Suggested- Avalara in Durham, North Carolina is seeking a highly motivated Sr. Manager, Business Operations to lead a team of analysts and support revenue initiatives. This role requires strong analytical expertise, people leadership skills, and the ability to translate data into ...Senior
$78.16k - $156.32k
Duke is seeking a Senior Business Manager to oversee administrative and financial operations within a complex academic clinical department... ...requires strong leadership in managing significant budgets, compliance with institutional policies, and providing operational support...SeniorRemote workFlexible hours- Precision BioSciences, Inc in Durham, NC is seeking a Quality Specialist III to provide dedicated quality assurance support for Chemistry... ...releases, performing deviation assessments, and ensuring compliance with regulatory standards. The ideal candidate will have a Bachelor...Senior
- BioSpace is seeking a Quality Assurance professional in Durham, NC to ensure compliance with regulations and approve quality documentation. The ideal candidate will have at least two years of QA experience, preferably in the pharmaceutical industry, and excellent...
- KBI Biopharma, Inc. is seeking an individual contributor for a Quality Assurance role focused on compliance with regulatory guidelines. This position involves interfacing with clients regarding batch status, managing quality issues, and ensuring systems are effective and...
- Novo Nordisk A/S in Durham, North Carolina seeks a Quality Assurance professional to ensure compliance with regulations and internal standards. The role involves documentation review, root cause analysis, and participation in audits. Candidates should have at least two...
- ...is looking for a qualified individual to oversee the compliance review of biopharmaceutical development GMP data.... ...regulated environment, along with substantial experience in QA data review, knowledge of USP, EU, and JP cGMP guidelines, and excellent analytical skills. #J-188...Senior
- Duke University’s Marcus Center for Cellular Cures seeks a QA Regulatory and Compliance Associate for our on-site GMP manufacturing lab in Durham, NC. You will ensure compliance with FDA and FACT standards, develop SOPs, and manage deviations, CAPAs, and investigations...
- KBI Biopharma in Durham, NC is seeking a senior QA reviewer to ensure CGMP compliance for biopharmaceutical development data, including release, in-process, and stability tests. You will evaluate method qualifications/validations, investigations, and deviations with a...Senior
$113k - $156k
## KBI: US - Principal QA SpecialistApplylocations: USA - NC -... ...individual is responsible for the compliance review of Biopharmaceutical... ...deviations. The Principal QA Specialist provides exemplary service to... ...required procedures, cGLP, and cGMP requirements.* Responsible for...Immediate start- OXB in Durham, NC is seeking a Quality Assurance Specialist for Raw Materials to provide quality oversight across the end-to-end production process in line with cGMP. You will drive material enrolment, risk assessments, and supplier change controls to ensure compliant,...Senior
- ...special project leader responsible for ensuring compliance with internal quality documents, regulatory requirements, and cGMP. The role will serve as Quality-to-Quality... ...sometimes SME for the Quality team reporting cross-QA metrics and status for KBI and clients. The role...Immediate startFlexible hours
- CBRE is seeking a Senior Facilities Manager in Morrisville, North Carolina, to oversee building operations and maintenance. You will manage teams, ensure compliance with regulations, and lead major capital projects. The ideal candidate has a Bachelor's Degree and 5-8 years...Senior
- ...appropriate quality standards and provide mentorship to project teams or functions to ensure overall compliance with AstraZeneca and Regulatory requirements are met. Provide QA input into internal manufacturing activities for Drug Substance and Drug Product, including...Senior
- Precision BioSciences, Inc. is seeking a Quality Specialist III responsible for providing quality assurance support for Chemistry, Manufacturing... ...review, deviation assessments, and supporting regulatory compliance. The ideal candidate will have a Bachelor’s degree in a life...SeniorWork at office
- A leading biotechnology company in North Carolina is looking for a Sr QA Specialist to enhance their Quality Management System. The ideal candidate will ensure compliance with regulations, support audits, and engage in continuous process improvement. Candidates should...SeniorFull time
- A leading biotech company in Morrisville, North Carolina, is looking for a Quality Assurance Specialist to oversee manufacturing quality and compliance for commercial and investigational products. The role requires 3 years of experience in the biotech or pharmaceutical...Full timeMonday to Friday
- ...Summary This position is responsible for the compliance review of Biopharmaceutical Development GMP... ...or MS with 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in‑process...
- Duke University in Durham, North Carolina is seeking a GMP, Quality Assurance Associate II to help ensure compliance and quality in their GMP programs. In this role, you will work with various partners, supporting quality systems and continuous improvement efforts. The...
- ...Senior Director, Technical Operations Location: Durham, NC, US Company: oxfordbiom... ...engineering systems, maintaining regulatory compliance, and driving effective technical troubleshooting... ...operating within clinical and commercial cGMP manufacturing environments, ideally...SeniorContract work
- ...pharmaceutical company in North Carolina seeks a QC Chemist III to ensure compliance in the testing and documentation of raw materials. This role... ...and have experience in a GMP environment. This is a full-time position offering senior level responsibilities. #J-18808-Ljbffr...SeniorFull time
- ...Research Associate (CRA) to advance clinical research and patient outcomes. This role involves leading site monitoring visits, ensuring compliance, and managing study progress. You will collaborate with cross-functional teams and build relationships with investigative sites....Senior
$59.83k - $99.96k
...dedicated Operations Manager in Durham, NC. This role focuses on independent oversight and training of study teams, ensuring participant compliance and data integrity. Candidates will manage recruitment initiatives and work closely with clinical teams to enhance participant...Senior- ...Research Associate (CRA) to advance clinical research. In this role, you will lead site monitoring visits and ensure study execution compliance and data integrity. Ideal candidates have a Bachelor's degree in life sciences and at least 1.5 years of monitoring experience....Senior
$68.97k - $127.01k
Senior Business Systems Analyst, Student Information Services Work Arrangement: Hybrid (On... .... You will serve as the Operations (Ops) Lead and a key strategic partner in supporting... ...improvements to enhance efficiency, compliance, and service delivery. Ensure system configurations...SeniorRemote work- Wolfspeed in Durham, North Carolina is seeking a Senior Tax Analyst to support Federal and State compliance and tax accounting under ASC 740. The ideal candidate has a minimum of 3 years in Public Accounting with Corporate income tax exposure and CPA certification. This...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior QA Specialist - cGMP Compliance & Ops. Be the first to apply!
- quality assurance associate Durham, NC
- qa specialist Durham, NC
- qa associate Durham, NC
- quality assurance specialist Durham, NC
- senior magento developer Durham, NC
- sr technical product manager Durham, NC
- senior manager pmo Durham, NC
- senior accountant part time Durham, NC
- senior systems specialist Durham, NC
- senior electrical designer Durham, NC

