1mo
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Corporate Food Safety Manager
Baltimore, Maryland, United States
$75k-$85k/yr OnsiteFull Time
Experience in food or beverage manufacturing with strong knowledge of HACCP, GMP/CGMP, ISO 9001, FDA regulations, quality audits, CAPA, Six Sigma and Lean; training and project management experience.
HACCP, GMP, CGMP, ISO 9001, FDA, Six Sigma, Lean, GD&T, GxP
1w
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Principal Scientist
Cherry Hill, New Jersey, United States
$118k-$135k/yr OnsiteFull Time
10+ YOEBS in Chemistry (advanced degree preferred), 10+ years pharmaceutical/analytical lab experience, method development/validation leadership, expertise in HPLC/UPLC/GC/dissolution/UV/FTIR and cGMP/ALCOA+/FDA/ICH/USP/EP, strong technical writing and communication.
HPLC, UPLC, GC, Dissolution, UV, FTIR, cGMP, ALCOA+, FDA, ICH, USP, EP
1mo
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Director Promotional Regulatory Affairs
Wilmington, Delaware, United States
HybridFull Time
5+ YOEBachelor's in science required; 5+ years total pharma/biotech/FDA experience with 3+ years in promotional regulatory affairs or OPDP/APLB; strong knowledge of FDA promotional regulations, drug development, and labeling; experience engaging FDA.
AZAP
1mo
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Associate Director, REMS Operations (68770)
Parsippany or West Chester or United States
$159k-$194k/yr HybridFull Time
7+ YOEBachelor's degree, 7+ years program/project management in regulated industry (preferably pharma), 2+ years working with FDA, vendor management, FDA/REMS regulatory expertise, MS365 skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, MS Project, MS365, database
3mo
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Assistant Quality Unit Manager
Gibbstown, New Jersey, United States
$70k-$90k/yr OnsiteFull Time
5+ YOEMinimum 5 years’ related experience; knowledge of FDA CFR 210/211, cGMP Pharma; FDA CFR 820 / ISO 13485 cGMP Medical Device;Bachelor’s in technical/science.
ERP/MRP, QMS
3w
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Director Promotional Regulatory Affairs
Gaithersburg or Wilmington
HybridFull Time
5+ YOEBachelor's in science,3+ years promotional regulatory experience,5+ years total pharma/biotech experience,knowledge of FDA OPDP/APLB and labeling,ability to lead MLR and engage with FDA.
AZAP
2w
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Risk Management Associate I
Malvern, Pennsylvania, United States
$75k-$85k/yr OnsiteFull Time
4+ YOEBachelor's in life sciences, 4+ years in FDA-regulated industry with quality/regulatory compliance experience; knowledge of ISO 13485/14971 and FDA QSR; strong communication, leadership, project and database skills.
1mo
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Associate Director, REMS Operations
Parsippany or West Chester
$159k-$194k/yr HybridFull Time
7+ YOE2+ MgmtBachelor's degree, 7+ years program/project experience in regulated industry (pharma preferred), 2+ years interacting with FDA, vendor and budget management, FDA regulatory knowledge, MS Office and project tools proficiency, leadership experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Microsoft 365
4d
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Director, Operations
Cherry Hill, New Jersey, United States
OnsiteFull Time
8+ YOEBS in engineering or life sciences required (MS/MBA preferred); 8+ years FDA-regulated pharmaceutical manufacturing experience, sterile injectable experience preferred; strong cGMP, FDA inspection, aseptic process, leadership, budgeting, and continuous improvement skills.
Lean, Six Sigma
2mo
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Clinical Research Site Director
Baltimore, Maryland, United States
OnsiteFull Time
8+ YOE5+ Mgmt8+ years in clinical research; 5+ years managing multiple trials; experience managing teams; knowledge of FDA regulations and GCP.
EDC, IVRS
2mo
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Food Safety and Quality Assurance Manager (Milford, DE, US, 19963)
Milford, Delaware, United States
OnsiteFull Time
5+ YOE5+ MgmtLead FSQA department, develop and enforce safety/quality processes, ensure regulatory compliance, partner with FDA/USDA, travel as needed.
2w
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BWI - Baltimore, MD - Utility Worker Porter
Baltimore, Maryland, United States
$16/hr OnsiteFull Time
Perform sweeping, cleaning, trash removal, and maintain sanitation per USDA/FDA/HACCP; work with cleaning agents; flexible for nights, weekends, and holidays.
2mo
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Director of Quality (Exton, PA, US, 19341)
Exton, Pennsylvania, United States
HybridFull Time
10+ YOE10+ years in FDA-regulated quality with multi-site leadership; governance of change control/document management; matrix leadership; external customer interface.
Excel, PowerPoint, QMS, Lean, Six Sigma, CAPA
2mo
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Site Engineering Lead
King of Prussia, Pennsylvania, United States
OnsiteFull Time
10+ YOE2+ MgmtBachelor’s degree in engineering; 10+ years in regulated manufacturing; 2+ years managing technical staff; experience delivering capital projects; FDA/EMA inspections.
Automation, Controls, Plant Control Systems
4d
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BATCHING TECHNICIAN (3572)
Millville, New Jersey, United States
$22/hr OnsiteFull Time
1+ YOEFollow batch recipes and SOPs, operate mixing and batching equipment, perform quality checks, maintain production records, and comply with GMP/HACCP/FDA standards.
4d
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Research Safety Reporting Specialist (DOM Infectious Disease)
Baltimore, Maryland, United States
$54k-$94k/yr OnsiteFull Time
3+ YOEBachelor's degree and 3+ years related clinical trials experience; knowledge of safety reporting, FDA guidelines, SOP development, regulatory compliance, and stakeholder communication.
Microsoft SharePoint, WordPress
2mo
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Senior Associate, Regulatory Affairs
Philadelphia or San Francisco
OnsiteFull Time
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
2mo
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AD/ Director, Clinical Regulatory Affairs Gene Therapy
Malvern, Pennsylvania, United States
OnsiteFull Time
8+ YOEBachelor’s or Master’s in life sciences; 8+ years regulatory affairs in biotech/pharma with gene therapy; FDA interactions; INDs/CTAs/BLAs; cross-functional collaboration.
1w
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Senior Quality Lead
Malvern or Spring House
HybridFull Time
6+ YOEBachelor's in a scientific/engineering field, 6+ years in regulated manufacturing, working knowledge of cGMP and FDA/EU guidance, inspection readiness, strong communication and analytical skills.
2w
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Supervisor Production
Bridgeville, Delaware, United States
OnsiteFull Time
4+ YOE1+ MgmtLead production teams, manage scheduling and performance, ensure compliance with FDA/USDA and safety rules, apply LEAN, use production reports, and be proficient with Microsoft Office.
Microsoft Office