Quality Site Leader - GMP, FDA & Compliance
Fagron Nederland BV
Fagron US in Canton, MA, seeks a Quality Site Head to own the quality systems and regulatory compliance for a 175-person facility. You will oversee QA/QC, investigations, CAPAs, and change controls to ensure final product safety and efficacy for FDA and state boards. You will lead audits, trainings, and regulatory interactions, while guiding budgeting and team development to maintain top-tier GMP standards and ongoing improvements. #J-18808-Ljbffr Fagron Nederland BV
- Fagron US is seeking a Quality Site Head for its 503B Outsourcing facility in Canton,... ...monitoring, and change controls to ensure FDA and state regulatory compliance. The role leads QA/QC investigations... ...for a ~175-person site. Strong GMP knowledge and leadership are...QualityWebsite
- Fagron US is seeking a Quality Site Head for its Canton, MA 503B outsourcing facility. You will lead QA/QC, ensure FDA/State compliance, and drive continuous improvement of quality systems... ...background in sterile manufacturing, GMP, and quality leadership is essential....QualityWebsite
$159.8k - $239.8k
...DescriptionThe Associate Director of GMP Operational Quality Assurance is an advanced technical resource... ...application of quality and regulatory compliance. The individual adapts to new and... ...operations at external manufacturing sites in alignment with the Vertex corporate...QualityWebsiteFull timeContract workWork experience placementSummer work$117.6k - $176.4k
...sourcing activities across multi-site, multi-country projects... ...Cost Lead time / time-to-market Quality and reliability Supply... ...Asia). Act as a procurement leader within the project team Influence... ...completing this form Job Posting Compliance Form.Looking to make an...QualityWebsiteFull timeTemporary workImmediate startFlexible hours$142.4k - $213.6k
...SummaryThe Procurement League Leader serves as the strategic... ...negotiations involving cost, contracts, quality, capacity, lead times,... ...technology, capacity, obsolescence, compliance, geopolitical, and business... ...to lead complex, multi-site and multi-country initiatives...QualityWebsiteFull timeContract workTemporary workImmediate startFlexible hours- ...research, manufacturing, and compliance in a rapidly evolving... ...Life Science Sector Leader is responsible for... ...standards, best practices, and quality benchmarks for life... ...labs, pilot plants, and GMP manufacturing spaces... ...ensuring compliance with GMP, FDA, EMA, and global...Quality
- ...infusion pharmacies, and sterile compounding sites. You will provide expert guidance to pharmacy leadership and ensure compliance with USP, state and federal requirements,... ...practices, data analysis, dashboards, and proactive quality improvements, while supporting #J-18808-...QualityWebsite
$109.25k - $149.5k
...SUMMARYThe Lead Auditor, Quality Compliance will form part of the... ...compliance with recognized ISO, GMP, GDP, GCP, and GLP,... ...team and liaising with site Quality representatives... ..., and business leaders as required or applicable... ...agencies (such as U.S. FDA, MHRA, TGA, Health Canada...QualityWebsiteFull timeTemporary workWork experience placement- ...activities across all hospital and compounding sites. You will oversee sampling, data management, and investigations to ensure compliance with USP 797 and regulatory standards.... ...with pharmacy leadership, and driving quality improvement across the enterprise. Strong...QualityWebsite
$50k
...SME, with Delivery Leader role, is responsible... ...develop and ensure quality execution of... ...of automation and compliance solutions across the... ...offboarding at client sites, as well as management... ...experience in GMP regulated environment... ...Expert knowledge of FDA regulations, ISPE guidelines...QualityWebsiteTemporary workFor contractorsWork experience placementWork at officeWeekend work$171.5k - $207.5k
...The Senior Manager, Quality Assurance... ...leadership and oversight of GMP Quality Assurance Operations... ...manufacturing site, ensuring compliant... ...closely with QA Compliance and Supplier... ...operational readiness for FDA (CBER), global... ...leadership.Influential leader capable of operating...QualityWebsiteLocal area$175k - $200k
...Opportunity Employer in compliance with Affirmative... ...a growing market leader across in vitro diagnostic... ...to maximize quality, customer satisfaction... ...Practices (GMP) industry such as biologics... ...travel to customer sites and remote offices... ...possibility. With FDA-registered, ISO-...QualityWebsiteHourly payWork at officeRemote workFlexible hours- About the job Quality Site Head for the 503B Outsourcing facility in Canton... ...are compliant for Federal (FDA) and State (Board of Pharmacy... ...and other Regulatory and compliance activities. Key Responsibilities... ...Extensive knowledge of FDA GMP and ISO 14644 Extensive experience...QualityWebsiteContract workFlexible hours
$237.7k - $356.5k
...Senior Director, CMC Product Leader (T1D) will lead the Chemistry,... ...BiopharmSci CGT, Manufacturing, Quality, Regulatory, Clinical,... ...technology transfer to manufacturing sites and support scale-up, production... ...-depth knowledge of GMP requirements, quality systems,...QualityWebsiteFull timeSummer workRemote workFlexible hours2 days per week- ...of contact for lab personnel, ensuring compliance and efficiency in all support activities... ...precision cleaning, inventory management, and quality control. Handle gas cylinder orders,... ...working independently at customer sites, which may include areas with chemical-based...QualityWebsiteShift work
$109.25k - $149.5k
...Lead Auditor for Quality Compliance at Integra LifeSciences will direct internal audits of the Quality... ...audits, evaluating compliance with GMP and ISO standards, and serving as a subject... ...with findings, recommendations, and site classifications Identify compliance gaps...QualityWebsite$237k
...activities Partner with regulatory and quality functions to develop CMC regulatory strategies... ...technology transfer to manufacturing sites and support production readiness and manufacturing... ...or major programs ~ Deep knowledge of GMP requirements, quality systems, and global...QualityWebsite- ...Description Gene Therapy CMO GMP Auditor – US & EU Regulatory Experience... ...evaluate manufacturing and Quality operations against applicable... ...evidence, identify meaningful compliance risks, and clearly document... ...operations. ~ Assess site operations against applicable...QualityWebsiteContract work
- Randstad USA seeks a Quality Control (QC) Technician for an on-site role in Norwood, MA. The position supports cGMP QC testing for raw materials, drug substances, and finished products, executing and troubleshooting analytical methods and maintaining SOPs and documentation...QualityWebsite
$94.6k - $141.8k
...Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible... ...to resolve complex quality and compliance issues. The role provides Quality... ...:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In...QualityWebsiteFull timeContract workSummer workRemote workFlexible hours2 days per week- ...in Canton, MA, seeks a QA Specialist I, Document Control to own the GMP document control program for the vaccine Drug Substance site. You will govern controlled documents, ensure GDP/ALCOA+ compliance, and serve as the EDMS SME to support inspection readiness and regulatory...Website
- ...Testing (AET) —a NETA-certified leader in electrical testing—where precision, compliance, and innovation drive everything... ...passionate about technical mastery and quality excellence, this is your... ...Perform and verify in-lab and on-site calibrations for electrical, mechanical...QualityWebsiteWork at office
$129k - $156k
...Validation ensures cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies... ..., Validation supports engineering, quality, manufacturing sciences and... ...Controls Systems preferably used in a GMP environment.Read and interpret drawings...QualityWebsiteLocal area- ...technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and... ...and experience to ensure compliance with pharmaceutical, biotechnology... ...a timely manner. Guarantee top quality of services provided to client by...QualityWebsiteContract workRotating shift
- ...Vertex is seeking a CMC Quality Compliance Director to lead inspection readiness and compliance across GMP sites, including external CMOs and internal manufacturing. You will drive risk-based governance and strategic improvements to quality systems. The role requires...QualityWebsite
$183.8k - $330.3k
...manufacturing capabilities. This leader will identify and prioritize... ..., MSAT, Automation, Quality, and site leadership to identify high‑... ...Validation (CSV), and regulatory compliance requirements. Potential to... ...robotics solutions in GMP, cleanroom, aseptic, laboratory...QualityWebsitePermanent employmentWork at office$156.6k - $234.8k
...Summary:The Associate Director, GMP Operational Quality is responsible for... ...application of quality assurance and compliance. The incumbent is... ...necessary during regulatory site inspections.Support review... ...with the ability to influence leaders, customers, or vendors to adopt...QualityWebsiteFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$184.6k - $277k
...DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for... ...of internal and external sites including evaluating, improving... ...governance across all GMP areas. This position focuses... ...relationships; a strategic change leader who delivers results through...QualityWebsiteFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$100.05k - $156.49k
...qualifications for a NBIS and NTIS inspection team leader. The primary responsibilities of this... ...on multi-discipline projects.Performs quality control reviews of discipline - specific... ...submits an unsolicited resume to this site does so with the understanding that the applicant...QualityWebsiteFull timeLocal area$116k - $174k
...will report to the Director of Quality and operate across departments... ..., outsourced model where compliance and inspection readiness are key... ...Quality Assurance, will provide GMP QA oversight for Tango’s CMC development... ...of global GMP regulations (FDA, EMA, ICH) applicable to...QualityContract work
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