Quality Operations Leader, GMP Compliance & Audits
Alcami Corporation
Alcami Corporation in Morrisville, NC is seeking a Senior Manager, Quality Operations. This role is vital for driving results and ensuring compliance with regulatory standards while leading the quality team. The ideal candidate will have over 10 years of experience, including at least 7 years in a supervisory role. Key responsibilities include managing quality reviews, overseeing audits, and ensuring the effectiveness of corrective actions. Strong leadership and pharmaceutical regulatory knowledge are critical for success in this position. #J-18808-Ljbffr Alcami Corporation
Vacancy posted 10 hours ago
Similar jobs that could be interesting for youBased on the Quality Operations Leader, GMP Compliance & Audits in Morrisville, NC vacancy
- Guerbet is seeking a QA Operations Sr. Manager in Raleigh, North Carolina to ensure quality leadership and oversight across site operations. This role involves managing QA processes in compliance with hygiene, safety, and regulatory standards, while promoting a strong quality...Quality
- Indivior is seeking a Sr. Specialist, Compliance QA to author Annual Product Reviews and... ...inspection readiness, participate in audits, and author Quality Agreements. Responsibilities include coordinating... ...-initiated changes, and QA review of GMP documents, with data compilation for...Quality
- Merck is seeking an Operations Manager for our Durham, NC site... ...performance, and ensure regulatory compliance across shifts and audits. The role requires 6+... ..., with experience in GMP environments and continuous... ...and a focus on safety and quality. #J-18808-Ljbffr MSD MalaysiaQualityShift work
- Indivior PLC seeks a Sr. Specialist, Compliance QA for the Raleigh site to strengthen quality systems. You will author Annual Product Reviews, manage change control... ..., participate in customer and regulatory audits, and ensure inspection readiness with ERP and GDocs...Quality
- Alcami-5 in Morrisville is seeking an Associate Director, Laboratory Quality Operations. This role involves leading the site Quality team to ensure compliance with FDA regulations and achieving quality standards in laboratory operations. Ideal candidates will have significant...Quality
$110k - $130k
Lighthouse Lab Services is seeking an experienced Director of Lab Operations for a neonatal clinical laboratory in Dallas, TX. This leadership position focuses on operational excellence, compliance, and quality testing in neonatal care. The ideal candidate will have a...Quality- ...Morrisville is seeking an Associate Director for Laboratory Quality Operations. This role involves ensuring compliance with FDA regulations, overseeing QMS, and providing... ...with responsibilities including regulatory audits and direct interactions with clients, requiring...Quality
$120k - $140k
External Quality Operation Manager (GMP) Full-time Sobi Location: United States... ...external network, driving compliance, collaboration, and continuous... .... Ensure quality audits of the CMO are performed according... ...with precision. As a leader, you take pride in coaching...QualityFull timeContract workTemporary workWorldwide- ...BioPharmaceutical, Inc. is seeking an Analytical Lab Operations Specialist II to support lab operations within the Quality Control and Analytical Development... ...materials, equipment, and budgets, ensuring compliance with GMP standards, and maintaining effective communication...Quality
- Guerbet is looking for a Supplier Quality Specialist in Raleigh, NC to ensure compliance with GMP standards and manage supplier quality oversight. This role involves... ...closely with cross-functional teams, conducting audits, and maintaining quality documentation. The ideal...Quality
- 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...Quality
- Ipro Networks Pte. Ltd. is seeking a GMP Quality Assurance Contractor for their Research Triangle Park location. This role includes managing... ...Management Systems and supporting a culture of quality compliance with applicable regulations. The ideal candidate has a Bachelor...QualityFor contractors
- 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...QualityFull timeMonday to Friday
- Sobi is seeking an External Quality Operations Manager (EQOM) in the United States to oversee external manufacturing partners and ensure GMP/GDP compliance across batches. You will act as the primary contact for CMOs, drive improvement, and maintain QTA alignment with global...Quality
$67.92k - $102.9k
...opening for a QA Regulatory and Compliance Associate in their GMP lab located at 2400 Pratt... ..., and maintain Standard Operating Procedures (SOPs) and... ...implement CAPAs. Monitor Quality Agreements with sponsors to... ...gathering. Background in auditing and writing reports. Experience...QualityImmediate start- Duke Clinical Research Institute is seeking a GMP, Quality Assurance Associate II to ensure compliance and quality in GMP programs. You will support the Marcus Center for Cellular Cures and play an important role in clinical research and patient-focused manufacturing....Quality
$50k
...scaling a best‑in‑class finance operations function supporting complex,... ...across Finance, Operations, Compliance, Legal, and Technology to... ...while enabling efficient, high‑quality program execution. Responsibilities... ...environment, ensuring audit readiness and improved financial...QualityFull timeTemporary workWork at officeImmediate start- ...Summary The Senior Manager, Quality Operations is accountable for... ...activities (CAPAs), and quality audits and inspections. This leader develops short and long‑... ...Responsibilities Ensures compliance with regulatory... ...experience is required. Prior GMP experience is required; prior...QualityMonday to FridayDay shift
Alcami Corporation
Morrisville, NC3 days ago - ...pharmaceutical company is seeking a quality assurance professional to oversee compliance in manufacturing and product... ...pharmaceutical industry focusing on GMP. Responsibilities include mentoring... ..., and ensuring compliance through audits and assessments. Strong interpersonal...Quality
- ...Solutions Services, LLC is looking for a QA Contractor specializing in GMP Quality Assurance for their RTP, NC office. The role involves managing the Quality Management System and ensuring compliance with GMP regulations. The ideal candidate has a Bachelor's degree and...QualityFor contractorsWork at office
- Guerbet is seeking a Quality Training Specialist in Raleigh,... ...training programs ensuring compliance with regulatory standards and quality across operations. This role requires a... ...ensuring training records are audit-ready and compliance with GMP principles. Must have strong...QualityWork at office
- ...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... ...deviation reports, support inspections, and educate staff on quality plans while driving continuous process improvements...Quality
- United Therapeutics Corporation is seeking a Manager, Global GMP Compliance to lead QMS, regulatory intelligence, and KPI reporting across multiple sites. The role ensures ongoing cGMP compliance with FDA and global agencies and supports inspections and recall activities...QualityRemote work
- ...Manufacturing Specialist in Durham, NC to ensure compliance with quality standards in drug substance... ...and support compliance with regulatory audits. The ideal candidate has a BS/BA in a scientific... ...at least 8 years of experience in a QA GMP environment. Strong interpersonal...Quality
- 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...QualityRemote job
- Liquidia seeks a Director/Senior Director of Quality Control to lead the QC function at our new North Carolina... ...testing, with accountability for day-to-day operations and compliance. The ideal candidate brings extensive GMP QC leadership, strong analytical chemistry...Quality
- ...seeking a Practice Administrator to provide strategic and operational leadership for multiple ambulatory clinics. The role includes oversight of clinic budgets, ensuring compliance, and driving patient care quality. The ideal candidate has at least five years of...Quality
- Kellanova in Cary, NC seeks an experienced Operations Supervisor to lead the night shift (5pm-5am) production team and oversee daily operations, ensuring production goals, quality control, and safety compliance. You will direct and support a team of operators, drive continuous...QualityNight shift
- ...North Carolina seeks a Programming and Operations Director to oversee station... ...station’s sound and image while ensuring quality programming and FCC compliance. Ideal candidates have 3-5 years in... ...and proficiency with AudioVAULT and Adobe Audition. #J-18808-Ljbffr RadioJobsQuality
- ...Orthopaedics in Apex. This role offers strategic and operational leadership for ambulatory clinics, focusing on high-quality patient care and financial sustainability. The... ..., financial management, and ensuring compliance with health regulations. A Bachelor's degree in...Quality
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Operations Leader, GMP Compliance & Audits. Be the first to apply!
Related searches
- operations leader Morrisville, NC
- operations lead Morrisville, NC
- quality Morrisville, NC
- quality lead Morrisville, NC
- quality distribution Morrisville, NC
- air quality Morrisville, NC
- quality equipment Morrisville, NC
- water quality scientist Morrisville, NC
- water quality Morrisville, NC
- rn quality Morrisville, NC