Audit Compliance Manager — GMP Quality & Regulatory
Alcami Corporation
Alcami Corporation in Durham, NC seeks a Manager of Audit Compliance to lead the audit response team and ensure quality and regulatory compliance. The role includes CAPA management, change control oversight, and supporting audits and inspections. The position requires 10+ years of related experience, GMP expertise, and strong leadership abilities to drive continuous improvement and timely client responses. #J-18808-Ljbffr Alcami Corporation
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Audit Compliance Manager — GMP Quality & Regulatory in Durham, NC vacancy
- MedPharm US is seeking an EHS Manager to lead Environmental Health... ...Safety programs across its GMP pharmaceutical manufacturing... ..., ensuring ongoing regulatory compliance and liaison with regulators.... ...hazard analyses, training, audits, incident investigations, emergency...Regulatory
$173.2k - $272.6k
...SummaryThe QMS Global Quality Compliance Director reports into... ...-making.Establish and manage agenda content to ensure... ..., trend analysis, audits, inspections, leadership... ...Global Coordination, GMP Compliance, Innovation... ...Quality Risk Management, Regulatory Compliance {+ 3 more}...RegulatoryFull timeFor contractorsLocal areaFlexible hours- Manager, Audit Compliance Location: US-NC-Durham ID: 2026-2238 At Alcami, we deliver... ...expertise and proven regulatory track record. Are you interested... ...performance in regard to quality standards, systems, and... .... Relevant Leadership and GMP experience required. Strong...RegulatoryMonday to FridayDay shift
$138.6k - $257.4k
...NCJoin Novartis as our QA Compliance and Systems Head and help shape the quality foundation that enables... ...Systems, Compliance, Audit and Inspection... ...Manufacturing, Engineering, and Regulatory functions. As a key... ...ResponsibilitiesLead the site Quality Management System and ensure...RegulatoryFull timeWorldwide- ...related hardware, ensuring reliability and compliance with regulatory requirements. The role involves... ...architectures, execute maintenance, perform audits, and drive process improvements to optimize efficiency and compliance in a GMP setting. #J-18808-Ljbffr NovartisRegulatory
- Director, Regulatory Affairs & Quality At ACHC we hire only the best. As a non-profit... ...requirements, and Quality Management System (QMS). This person... ...leadership on emerging compliance risks, evolving regulatory... ...Promoter Score, internal audits, escalations, complaints against...RegulatoryWork experience placementWork at officeRemote workRelocation package2 days per week
- ...support laboratory computerized systems, ensure regulatory compliance, and collaborate with cross-functional teams to sustain... ...+ years in pharma/biopharma lab operations, with GMP system experience and strong vendor management skills. #J-18808-Ljbffr Novartis Group CompaniesRegulatory
- Duke University’s Marcus Center for Cellular Cures seeks a GMP Compliance Investigator - Equipment and Facilities to ensure FDA and FACT-... ...manufacturing lab operations in Durham, NC. The role focuses on QA/regulatory activities for cGMP programs, deviations, CAPAs, and SOPs...Regulatory
- Headwater Science in Durham, NC seeks a talented QA Program Manager to lead Regulatory Affairs and Quality Assurance, building and maintaining quality systems and ensuring compliance with regulatory standards. You will oversee GDP, QMS, SOPs, and GCP/GPP processes; collaborate...Regulatory
- A leading biopharmaceutical company is seeking a Manager/Sr. Manager of R&D Quality to ensure compliance with regulatory requirements and oversee GCP activities. This position requires strong communication skills, a background in clinical QA, and expertise in GCP regulations...RegulatoryRemote job
- ...pharmaceutical company is seeking a quality assurance professional to oversee compliance in manufacturing and... ...industry focusing on GMP. Responsibilities... ...mentoring project teams on regulatory standards, leading... ...ensuring compliance through audits and assessments. Strong...Regulatory
- ...Center for Cellular Cures seeks a QA Regulatory and Compliance Associate for our on-site GMP manufacturing lab in Durham, NC.... ...standards, develop SOPs, and manage deviations, CAPAs, and investigations... ..., and educate staff on quality plans while driving continuous process...Regulatory
- ...Executive Director of IT Quality & Compliance to join our team in Durham,... ...enterprise risk and global regulatory requirements (GxP, SOX, GDPR... ...internal controls to ensure audit readiness and regulatory compliance... ...improve the IT Quality Management System (QMS), including...RegulatoryTemporary workCasual workInternshipWork at officeRemote workMonday to FridayFlexible hoursShift workNight shift3 days per week
$67.92k - $102.9k
...immediate opening for a QA Regulatory and Compliance Associate in their GMP lab located at 2400... ...implement CAPAs. Monitor Quality Agreements with sponsors... ...and facilities events. Manage and drive closure of deviations... .... Background in auditing and writing reports. Experience...RegulatoryImmediate start- ...Overview: The Senior Manager, Compliance and Training, will provide... ...application of Global Quality Policies & Standards,... ...GxPs, global HR/Legal/regulatory training, and... ...Support site and function audit preparations with respect... ...relevant experience in a GMP and GXP environment...RegulatoryWork at office3 days per week
- GMP Compliance Investigator - Equipment & Facilities Overview... ..., authoring quality documentation, and partnering... ...skills, and the ability to manage complex investigations... ...FDA and applicable regulatory requirements. Author... ...including responses to audit observations. Monitor...RegulatoryLocal area
- ...Supervisor of Quality Control (QC) We are the first... ...maintaining strict compliance with cGMP regulations... ...contract laboratories, manages data review from these... ...operational excellence and regulatory readiness within the... ...experience in a GMP pharmaceutical laboratory...RegulatoryContract workShift work
IVIVA Medical
Durham, NC21 hours ago - ...Government's Tax Administration division seeks an experienced manager to oversee the Personal Property and Compliance programs. You will supervise staff, oversee property tax appraisals, and coordinate external audit activities. The role requires a Bachelor’s in accounting...
- ...an experienced Associate Director/Director, Quality Assurance to serve as the Site Quality Head... ...establish and lead QA operations ensuring CGMP compliance and robust quality systems across manufacturing, analytics, and regulatory readiness. The role requires 12+ years in QA...Regulatory
- ...the United States is seeking a Senior GMDP Quality Assurance Manager to lead the site QA function, ensuring GDP/GMP compliance for distribution and manufacturing activities... ...QA staff, and partner with supply chain, regulatory affairs, and operations to support client solutions...Regulatory
$109.86k - $191.06k
...Associate Director, Quality AssuranceWork... ...You. The Office of Regulatory Affairs and Quality... ...strategic leadership for GMP quality programs... ...oversee quality management systems across... ...support inspections and audits, and lead... ...role in supporting compliance, operational excellence...RegulatoryWork experience placementWork at officeDuke University
Durham, NC16 hours ago- ...experience to ensure compliance with pharmaceutical,... ...assigned client facilities Quality Management System (QMS), or in... ...and/or internal auditing within the regulated... ...organizational, Customer and regulatory problems and... ...but not limited to, GMP, GDP regulations and...Regulatory
- ...Sr. Director, Quality Control and Analytical Development... ...implementation of GMP industry standard... ...deliverables to meet site and compliance objectives... ...participates in client visits, audits, and regulatory agency inspections... ...of products Manages technology transfers...RegulatoryFlexible hoursShift work
MedPharm
Durham, NC3 days ago $86.71k - $140.13k
...Be You. The Office of Regulatory Affairs & Quality (ORAQ) is looking for a GMP, Quality Assurance Associate... ...of quality and compliance. You will play a key part... ...preparing for external audits and/or site visits. Experience... ..., and time‑management skills. Ability to train...RegulatoryWork experience placementWork at officeShift work- ...an experienced Global Trade Compliance Manager to oversee and ensure adherence... ...with trade laws; translates regulatory language into practical and... ...and identifies potential quality, service, and cost issues related... .... Conduct post-entry audits on entry packets for accuracy...RegulatoryFull timeWork at officeLocal area
- ...the Analytical and Formulation Sciences team. You will perform GMP testing for product release and stability, support analytical method... ...advanced technical writing and presentation skills, with familiarity in cGMP and regulatory expectations. #J-18808-Ljbffr KBI BiopharmaRegulatory
- ...vendor data ecosystem? As a Sr. Vendor Data Quality Analyst at Fidelity Investments, you... ...quality, data governance, primary data management, procurement, or vendor management. Ideal... ...rules and regulations of numerous self-regulatory organizations, including FINRA, among others...RegulatoryFull time
$67.92k - $102.9k
GMP Compliance Investigator - Equipment and Facilities - Marcus... ...opening for a QA Regulatory and Compliance Associate... ...experience from the Quality Assurance perspective... ...and facilities events. Manage and drive closure of deviations... .... A background in auditing and writing reports...RegulatoryTemporary workWork experience placementImmediate startWorldwide- ...team on contracted client programs. You will perform GMP testing, support method transfer, qualification and... ...qPCR are a plus. The role emphasizes producing high-quality data and documentation suitable for regulatory submissions, with adherence to cGMP and GLP requirements...Regulatory
- SBM Management Services, LP in Durham, NC seeks a Critical Environments Director to lead GMP-regulated services and critical environments initiatives, support business... ...with cross-functional leaders to ensure regulatory compliance and efficient service delivery. #J-188...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Audit Compliance Manager — GMP Quality & Regulatory. Be the first to apply!
Related searches
- regulatory manager Durham, NC
- manager regulatory affairs Durham, NC
- head compliance Durham, NC
- compliance manager Durham, NC
- compliance director Durham, NC
- regulatory affairs director Durham, NC
- regulatory & compliance manager Durham, NC
- quality manager Durham, NC
- training and quality manager Durham, NC
- global quality manager Durham, NC