Client-Facing QA Lead — Regulatory & CAPA Excellence
KBI Biopharma Inc.
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 product release processes. The ideal candidate will possess a BS/BA degree in Science or Engineering and have a minimum of five years of experience in the pharmaceutical industry. KBI offers a fast-paced environment and opportunities for career advancement. #J-18808-Ljbffr KBI Biopharma Inc.
- ...North Carolina is seeking an experienced QA professional responsible for the review and approval of Deviations and CAPAs to ensure compliance with GMP standards.... ..., along with actively participating in client audits and regulatory inspections. The ideal candidate will have...Regulatory
- ...Biopharma Inc. in Durham, NC is seeking a Senior QA Specialist to oversee the review and approval of deviations and CAPAs supporting GMP manufacturing operations. The... ...junior QA staff, ensuring compliance with regulatory requirements. KBI offers a collaborative work...Regulatory
- ...and approving deviations and CAPAs to ensure GMP compliance, mentoring... ...of 14 years' experience in a QA cGMP regulated environment,... ...understanding of quality systems and regulatory guidelines. This position... ...contribute significantly to client audits and external reviews. #J...Regulatory
$110k - $140k
...A leading research organization is seeking a Mid-Senior Quality Assurance Manager to support the development of new drugs through expert... ...and organizational skills and have a background in regulatory environments. The position offers a competitive salary ranging...Regulatory- ...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 compliant....Regulatory
$110k - $140k
...corrective and preventive actions (CAPAs) Authoring / reviewing... ...applications including Word, Excel, and PowerPoint and the ability... ....g., GLPs, Part 11, CLIA) and regulatory guidance (e.g., Bioanalytical... .... Contribute and take part in client evaluations, visits and bid defenses...RegulatoryFull timeContract work- ...of cybersecurity services for government and regulated clients, ensuring compliance with security standards and requirements... ...will have experience in Security Operations, strong regulatory knowledge, and excellent communication skills. #J-18808-Ljbffr Women Veterans InteractiveRegulatoryFull time
- ...approval of Deviations and CAPAs in support of GMP... ...closure. Mentors junior QA staff in deviation/CAPA... ...deviations and assists in leading daily triage meetings.... ...CAPAs. Notifies the Client of deviations. Supports... ...Support client audits and regulatory inspections as required...Regulatory
- ...Specialist Deviations and Client SupportSkip to main... ...approval of Deviations and CAPAs in support of GMP... ...closure. Mentors junior QA staff in deviation/CAPA... ...deviations and assists in leading daily triage meetings.*... ...client audits and regulatory inspections as required...RegulatoryImmediate start
- ...Management, Clinical Team leads and with other... ...with MRL QA and acting as the... ...maintaining current regulatory inspection knowledge... ...findings, responses and CAPAs, worldwide. Acts... ...skills. Excellent planning and organizational... ...travel to clients/ site locations with...RegulatoryFull timeContract workWork at officeWorldwide
$113k - $156k
KBI Biopharma, Inc. in Durham, North Carolina seeks a Principal QA Specialist to oversee compliance review of GMP data. This role includes... ..., providing QA support for laboratory activities, and ensuring regulatory compliance throughout product lifecycle activities. The ideal...Regulatory- ...Public Finance Attorney to handle financing transactions and provide legal advice to public sector clients. The role involves significant client interaction, regulatory compliance, and the opportunity to work with experienced attorneys in a collaborative environment. The...Regulatory
$130k - $140k
...point of accountability for these clients, ensuring that Pearson meets contractual, regulatory, and assurance obligations while... ...evidence quality, and customer‑facing security operations. Skills &... ...or highly regulated customers. Excellent stakeholder management and written...RegulatoryFull time$65.25k - $169.4k
...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 background in Quality Assurance, at...Regulatory- ...driving compliance to regulatory Good Manufacturing... ...drive delivery of client solutions with... ...mindset What You'll Do Lead and manage day-to-... ..., complaints CAPAs and Change Controls... ...coach, and develop the QA site operations team... ...meet both aspects. Excellent communication...RegulatoryTemporary work
- ...we serve life sciences clients in six global markets:... ...required by that QMS. Lead the events & root cause... ...Office applications (Word, Excel, PowerPoint, Outlook)... ..., customer and regulatory problems and formulate... ...Monitors and manages clients CAPA’s non‑conformances and...Regulatory
- ...and approval of Deviations and CAPAs in support of GMP... ...and closure. Support external client review and resolution of comments... ...CAPAs as needed. Mentors junior QA staff in deviation/CAPA review... ...meetings. Support client audits and regulatory inspections as required. Provides...Regulatory
- Senior QA Specialist Deviations and CAPAs page is loaded## Senior QA Specialist Deviations and CAPAslocations... ...EtQ and closure. Support external client review and resolution of comments for... ...meetings. Support client audits and regulatory inspections as required.* Provides...RegulatoryImmediate start
$120.97k
...Job Title Industrial Client Service Leader - Industrial Water/Wastewater... ...by: Responsibilities Leading business development, client... ...systems, wastewater reuse, and regulatory compliance. Bachelor's degree in engineering preferred. Excellent interpersonal and communication...RegulatoryTemporary workVisa sponsorship$75.4k - $188.6k
...Action Prevention (CAPA) and Effectiveness... ...or during similar QA activities as assigned... ...audit lifecycle. Lead/collaborate/support... ...initiated audits and mock regulatory inspections, and... ...skills. Excellent problem solving, risk... ...coworkers, managers and clients. Benefits and Compensation...Regulatory- ...Materials Testing Team Lead to join our Durham office... ...and the U.S. We offer excellent career growth, a... ...quality, and excellent client service. Our ideal candidate... ...experience. Interact with regulatory agencies, construction... ...strict adherence to QA/QC. Developed critical...RegulatoryContract workFor contractorsLocal areaFlexible hours
- Initial Therapeutics, Inc. is seeking a Lead QA Floor Lead Tech in Durham, North Carolina, responsible for ensuring quality oversight... ...ideal candidate has a strong background in aseptic manufacturing, excellent communication skills, and is detail-oriented. This position...
- ...through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.Are you interested... ..., corrective action activities (CAPAs), and quality audits and... ...Knowledge of auditing preferred. Excellent skills in leadership, coaching and...RegulatoryMonday to FridayDay shift
- ...and passion for helping our clients be successful. They are self‑... ...developing their technical and regulatory knowledge base to enable the... ...growing, employee‑centric, forward‑facing company. Our teams work... ...and workflows. Commitment to excellence and ALL4’s core values;...RegulatoryWork at office
$150k - $165k
...25 We are seeking a Director to lead a high-performing, patient-centric client services program. This role is responsible... ..., scalability, and operational excellence Facilitate collaboration between... ..., ensuring compliance with SLAs, regulatory requirements, and contractual...RegulatoryFull timePart timeWork at officeImmediate startWork from home- ...families. We're looking for a Client Service Advocate to join our... ...Wealth Advisor and Operations Lead. What You'll Do Client Relationship... ...client documentation meets regulatory and practice standards.... ...software applications (Word, Excel, Power Point, Outlook) required...RegulatoryPermanent employmentWork at officeLocal areaFlexible hours
- ...established quality standards and regulatory requirements, playing a key... .... Responsibilities Lead and oversee site Quality Systems... ...execution of deviation management, CAPA, change control, quality metrics... ...coordinator for corporate, client, and regulatory inspections, including...Regulatory
- ...Carolina. In this role, you will provide exceptional service to clients, managing relationships and offering tailored financial... ...help clients achieve their goals while ensuring compliance with regulatory requirements. The ideal candidate will have at least 1 year of...Regulatory
$75.4k - $188.6k
Sr. QA Auditor - 41779 page is loaded## Sr... ...Action Prevention (CAPA) and Effectiveness... ...activities and projects for clients within budget and... ...audits and mock regulatory inspections, and... ...audit lifecycle • Lead/collaborate/support... ...interpersonal skills.. • Excellent problem solving,...RegulatoryFull timePart timeImmediate startWorldwide- ...currently recruiting for a Senior QA Specialist, Compliance and... ...), including audit reporting, CAPA assessment, and follow‑up. Maintain... ...to include FDA, EU, JP regulatory requirements as well as ICH/ISO... ...with a mission to enable its clients to deliver life changing therapies...RegulatoryRemote work
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