Senior Quality Assurance Manager - Regulatory Compliance
LifeScience Logistics
A leading logistics company in North Carolina is seeking a Quality and Compliance Manager to oversee licensing and quality assurance for regulatory compliance. Candidates should hold a Bachelor of Science degree and have at least 5-7 years of experience in the medical device or pharmaceutical fields, including supervisory experience. The role requires strong communication, organizational, and analytical skills, along with knowledge of federal and state laws. This position may involve up to 20% travel and light to medium physical demands, with a focus on quality and compliance within both office and warehouse environments. #J-18808-Ljbffr
$113k - $156k
...seeks a Principal QA Specialist to oversee compliance review of GMP data. This role includes... ...for laboratory activities, and ensuring regulatory compliance throughout product lifecycle... ...with internal stakeholders to maintain quality culture. The salary ranges from $113,000...Senior- ...Summary The Director (Senior Director), Regulatory Affairs will be... ...in alignment with and in compliance with local and regional requirements... ...compilation and submission of high-quality INDs, CTAs, BLAs/MAAs,... ...and implement data management strategies aligned with company...SeniorLocal areaWorldwide
- ...About the job Senior/Director - Regulatory Affairs Director / Senior Director... ...success and sustain compliance. Confirm that regulatory... ...Build and roll out data management approaches that align with... ...capabilities and a drive for high-quality work. Preferred...SeniorWorldwide
$110k - $140k
...research organization is seeking a Mid-Senior Quality Assurance Manager to support the development of new... ..., authoring SOPs, and ensuring compliance with quality management systems. The... ...organizational skills and have a background in regulatory environments. The position offers a...Senior- ...Durham, North Carolina is seeking a Senior Specialist in Quality Assurance. The role involves overseeing the... ...Qualification Program, ensuring compliance with regulations, and performing vendor... ...skills. The position requires management of audits and the ability to work...Senior
- ...conducting independent audits to ensure compliance with regulations. You will prepare... ...audit reports, consult on regulatory matters, and manage quality issues. Ideal candidates will have... ...experience, including 3 years in Quality Assurance. The role offers competitive pay and...Senior
- JobRx, Inc. is looking for a Senior Director of Quality Assurance in Morrisville, NC. This hybrid role involves developing a quality management system compliant with FDA regulations, leading a QA team, and overseeing clinical quality assurance. Candidates should have 1...Senior
$65.25k - $169.4k
...A global pharmaceutical leader seeks a Quality Assurance professional to oversee API external manufacturing operations. This role involves ensuring compliance with cGMP and regulatory requirements throughout the manufacturing process. The ideal candidate will have a strong...Senior- ...lean further into a role in training, compliance, and quality control. This role will lead the... ...ensure training programs are aligned with regulatory requirements, evolving business... ...compliant and inspection-ready GPS Quality Management System (QMS). Minimum Requirements...SeniorWork at office3 days per week
$222k - $370k
...Ensure the development of appropriate regulatory strategies and execution for assigned asset... ...goal has to be achieved while ensuring compliance with both internal GSK process / policy... ...product life. Advocate persuasively to senior leaders in GSK and in Health Authorities...SeniorLocal area$144.38k - $240.63k
...Waltham Posted Date: May 26 2026 Senior Manager - CMC Regulatory Affairs Biopharm Development... ...activities, both internally (for increased compliance, harmonisation and efficiency) and externally... ...major inspections (e.g. PAI's) or quality incidents (PIRCs). * Has...SeniorLocal areaWorldwide- A consulting service provider is seeking a Technical Test Lead for Automation Testing in Durham, NC. The role requires at least 4 years of IT experience with a focus on automation tools like Selenium and Cucumber. Candidate must possess strong analytical and leadership ...SeniorFull timeRelocation package
$120.5k - $276.5k
...Hobbsnews is seeking a Senior Quality Assurance Engineer to lead project teams and ensure quality in software testing. This role offers a hybrid work model requiring in-office presence 2 days a week. Candidates should have a strong background in software systems and a...SeniorWork at office2 days per week- ...The Quality Assurance Manager ensures consistent quality standards, compliance and continuous improvement as well as provides hands‑on support to ensure the site meets regulatory requirements, customer expectations and organizational goals. Responsibilities Establish...Temporary workWork experience placement
- ...leading biotech company in Durham, North Carolina is seeking a Supervisor of Quality Control to oversee QC testing of raw materials, in-process samples, and drug products. This role ensures compliance with cGMP regulations while supporting innovative regenerative organ...
- ...Req # WD00099070 Career area: Product Management Country/Region: United States of America... ...usability and competitiveness Support regulatory, compliance, and ESG considerations where... ...implementationConfidence engaging with senior engineers, architects, and security expertsProven...SeniorFull timeLocal area
- ...KBI Biopharma, Inc. is seeking a Quality Support Supervisor in Durham, North Carolina.... ...the Quality Support function, ensuring compliance and quality throughout the biopharmaceutical... ...The supervisor will be responsible for managing QA oversight, performing inspections, and...
- ...facing support on specific regulatory topics and Quality Issues.Hosting of external... ...for study problems.Manages the QA-to-QA relationship... ...clients.Provides support to Compliance Lead and Sr. management as... ...Regulatory Compliance and Quality Assurance (RC and QA)...Senior
- A biotechnology company is seeking a Quality Assurance Professional in Durham, NC. This individual will act as a client liaison, ensuring compliance with quality metrics and regulatory standards. Responsibilities include investigating deviations, leading audits, and supporting...
- Associate Director or Director Regulatory Strategy (Clinical &... ...clinical operations, nonclinical, quality and program leadership. This... .... Regulatory Intelligence & Compliance • Monitor evolving... ...strategy. • Strong project management and organizational skills. Key...Remote work
$138.6k - $257.4k
...utica is seeking a Head of QA Ops and Compliance in Durham, NC. This Associate Director... ...strategic and hands-on leadership for Quality Assurance within the Small Molecule Operations division... ...excellence in cGMP compliance and regulatory execution. The ideal candidate will...- A leading pharmaceutical company is looking for a Sr. Quality Specialist to ensure compliance with GMP standards in a fast-paced environment. This role... ...including maintaining quality databases and supporting regulatory inspections. #J-18808-Ljbffr Alcami CorporationSeniorWeekend workDay shift
- ...advertising by using this toggle switch. For more information on your rights as a United States consumer see our privacy notice. Manage Consent Preferences Always Active Opt Out of Sale of Sharing/Targeted Advertising Opt Out of Sale of Sharing/Targeted Advertising...Senior
$79.88k - $119.72k
...Orange Water and Sewer Authority (OWASA) is seeking a skilled Laboratory Supervisor for its Wastewater Management Laboratory. The role involves ensuring compliance with laboratory procedures, overseeing staff, and conducting analytical testing. Candidates should have...- ...Quality Assurance Operations Lead The Quality Assurance... ...Assurance to ensure compliance to regulations and internal... ...during Client and regulatory audits. Collaborate with Laboratory management to support company goals... ...assessments to senior management as required...
- ...Bioventus LLC in Durham is hiring a Regulatory Affairs Manager responsible for developing and executing global regulatory strategies. The ideal... ...for approvals, liaise with regulatory agencies, and monitor compliance with international regulations. Applicants should have a...
- ...Position Summary You will lead regulatory strategy for precision medicine and digital... ...development through lifecycle management. Ensure regulatory compliance for companion diagnostics, software... ...major markets. Experience influencing senior stakeholders and advocating...Work at officeLocal area2 days per week3 days per week
- ...next phase of growth and is seeking a Senior Manager, Regulatory Affairs who can operate successfully... ...Partner with Technical Operations/CMC, Quality, and external partners to ensure... ...Support inspection readiness and quality compliance by maintaining complete, accurate,...Senior3 days per week
- ...Regulatory Affairs Manager page is loaded## Regulatory Affairs Managerlocations: Durham, NCtime type... ...plan, prepare, and obtain approvals and compliance with national and international... ...facilitates in the remedy of inefficiencies in Quality systems and processes.11. Contribute...
$165k - $220k
...the future. The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence... ...Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory... ...highquality submissions, and manage regulatory risk across the product...Temporary workWork visa
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