Senior QA Lead, External CMOs - GMP Compliance
Initial Therapeutics, Inc.
Initial Therapeutics, Inc. is hiring for a QA management role focusing on ensuring compliance within contract manufacturing operations. The role involves oversight of Quality Management Systems, partnering with quality leaders, and supporting validation efforts for drug products. Ideal candidates will have over 7 years in the pharmaceutical sector, understanding regulatory compliance, and are expected to frequently collaborate across functional teams. The position includes travel requirements of up to 30% and offers a competitive salary range. #J-18808-Ljbffr Initial Therapeutics, Inc.
$153.6k - $230.4k
Daiichi Sankyo US is seeking a Quality Assurance Lead to oversee Contract Manufacturing compliance in Basking Ridge, New Jersey. The successful candidate will be responsible for ensuring that all contracted organizations comply with FDA regulations and internal quality...SuggestedContract work- ...professional to oversee contract manufacturing organizations, ensuring compliance with FDA regulations and internal standards. Your role will... ...experience and knowledge in drug manufacturing and QA compliance. This position is poised for impact in a collaborative...SuggestedContract work
$226.28k - $377.13k
...(CDMO).The role leads the site's independent... ...supply and compliance while promoting... ...an independent QA function, with authority... ...Sankyo’s GMP Quality Manuals... ...in internal and external manufacturing site... ...with Tech Unit Senior Leaders (L-2 Leaders... ...overseeing CMOs (including understanding...SuggestedContract workLocal area$83.71k - $109.87k
Legend Biotech US, based in Raritan, NJ, is seeking a QA Lab Compliance Specialist III to provide oversight of Quality Control Laboratories. This role involves ensuring compliance with global standards and supporting regulatory inspections and audits. Candidates must hold...Senior- Legend Biotech in Raritan, New Jersey is seeking a QA Lab Compliance specialist III to oversee quality and compliance for Quality Control Laboratories. The role requires strong knowledge of cGMP regulations, experience in QA, and the ability to support regulatory inspections...SuggestedWork experience placement
- Legend Biotech USA is seeking a QA Laboratory Compliance Specialist III based in Raritan, NJ. This role involves providing quality and compliance oversight for testing Advanced therapy products in collaboration with various Quality Control departments. The ideal candidate...Senior
- Legend Biotech, located in Raritan, NJ, is seeking a QA Laboratory Compliance Specialist III to oversee quality control laboratories and ensure all practices comply with global regulatory requirements. The ideal candidate will have at least 2 years of relevant experience...Senior
$120k - $150k
...Overview The QA Product Manager (Sterile... ...safety, and regulatory compliance of sterile... ...manufactured by third-party CMOs. This position... ...internal teams and external manufacturers to ensure... .... Responsibilities Lead and coordinate end-... ...of global GMP and regulatory requirements...Full timeWork at officeLocal area- A leading pharmaceutical company is seeking two Senior Quality Specialists on a contract basis to ensure quality assurance and compliance support for clinical products. Responsibilities include detailed... ...field and at least 5 years of GMP experience. This is a crucial role...SeniorContract work
- ...Basking Ridge, New Jersey. This role involves ensuring quality oversight of internal sites and CDMOs, and leading an independent QA function to maintain compliance with industry regulations. The ideal candidate will have over 10 years of experience in Quality Assurance...
- ...processes at internal sites and Contract Development and Manufacturing Organizations (CDMO). This role includes leading a Quality Assurance team and ensuring compliance with international regulations. The ideal candidate will have over 10 years of experience in Quality...Contract work
- ...Squibb is seeking a Sr. Director, External Manufacturing Quality for Cell Therapy, to lead QA activities across global CMOs and CTLs. You will drive cGMP compliance, risk management, and continuous... ...the ExM network, partnering with senior leaders to ensure product quality...
$238.2k - $288.64k
Sr. Director, External Manufacturing Quality... ...level of cGMP compliance and the safety, efficacy... ...Centers. Lead a team of Quality Senior Directors or others... ...Agreements for Suppliers/CMOs are created and... ...according to GMP and requirements,... ...Manufacturing QA. A thorough understanding...SeniorHourly payFull timeContract workTemporary workPart timeFor contractorsSummer workWork at officeLocal areaRemote workFlexible hoursShift work- A biopharmaceutical company is looking for a QA Validation Specialist III in Raritan, NJ. This role involves providing quality oversight... .... The position offers a dynamic work environment focusing on compliance and continuous improvement initiatives. #J-18808-Ljbffr BioSpaceSenior
$145k - $170k
External Supply Operations, Sr. Manager, US This range... ...External Supply Operations Senior Manager is responsible... ...to drive performance, compliance, and continuous... ...quality product supply. Lead the internal Virtual Site... ...Manufacturing Practices (GMP) and regulatory requirements...SeniorFull timeContract workWorldwide$130k - $160k
...regulatory requirements (QMSR, GMP, ISO, and other global... ...and regulatory compliance. Partner with R&D, supply... .... Build, mentor, and lead a high-performing quality... ...and quality control (QA/QC) team, fostering a culture... ...employees through senior management. Must possess...SeniorHourly payWork experience placementFlexible hours- BioSpace is seeking a QA Laboratory Compliance Specialist III in Raritan, NJ to oversee quality assurance activities for all QC laboratories. The role includes training and collaborating with various QC teams to ensure compliance with global standards and regulatory requirements...Senior
$61.45k - $80.66k
...patients worldwide. QA Investigations Lead I Location: Raritan,... ...product in a sterile GMP environment. The ideal... ...as needed. Support compliance activities for site Quality... ...with internal or external customers.... ...drug‑free workplace. Seniority Level Mid‑Senior Level...Full timeTemporary workWork experience placementWorldwideFlexible hours- ...Assurance, Drug Product, in Basking Ridge, NJ. The role is crucial for quality oversight of internal sites and CDMOs, leading a team to ensure compliance with international regulatory frameworks. Ideal candidates have over 10 years in Quality Assurance and strong...
- ...Sankyo US is looking for a Director, PV QA DSI to lead quality assurance strategies within Clinical... .... The role involves ensuring compliance with regulatory requirements and actively engaging with internal and external stakeholders to maintain high-quality standards...
- ...seeking a Food Safety & Quality Manager based in Parsippany, NJ. This role ensures FSQ standards across external operations by implementing food safety programs and leading audits. The ideal candidate has a degree in Food Science and 8+ years in food safety management,...Senior
$120k - $135k
...Description: Our client is currently seeking a Senior Auditor, Auditing who will be responsible... ...response to all company internal and external customers concerning audit related... ...pharmaceutical industry, quality systems, GMP and GDP, and good understanding of GCP, GVP...Senior$64.01k - $88.02k
...Technician III to conduct claim evaluations and testing activities on sample materials. The ideal candidate will lead lab maintenance, ensure food safety compliance, and participate in problem-solving teams within the lab environment. The prospective employee should have an...Senior$150.8k - $226.2k
...strategic and proactive QA Leadership and support development... ...adequate quality and compliance guidance in close... ...PV inspections/Audits. Lead in a proactive and strategic... ...(KQIs). Interact with senior CSPV leadership teams to... ...functions (R&D Quality, GMP/ IMP QA, Audit, Quality...SeniorLocal areaWorldwide$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory... ...integrity, regulatory compliance, and trust with cross... .... Responsibilities Lead development of Global... ...internal and external stakeholders across global... ...sites, CMC technical, QA, and CMOs. Maintain expertise in...SeniorFull timeWork at officeLocal area- ...Legend Biotech in Raritan, NJ is seeking a QA Investigations Lead I to provide quality oversight for... ...cell therapy production in a GMP environment. The ideal candidate will... ...include managing investigations, ensuring compliance with quality standards, and supporting...
- ...Senior Financial Analyst, Sox Compliance The Senior Financial Analyst, SOX Compliance will be the dedicated contact in the Program... ...) Facilitating Audit SOX annual reviews: Lead process overview/walkthrough with external and internal auditors and prepare the...Senior
- ...Preconstruction Estimator to join our New Jersey team. You will support Lead Estimators in all estimation functions during the preconstruction launch, focusing on accuracy, value engineering and GMP readiness. This role requires strong collaboration with owners,...Senior
$184.24k - $276.36k
...to provide strategic regulatory leadership for U.S. promotional communications. This senior role involves guiding compliant communications in alignment with FDA regulations while leading cross-functional collaboration. The ideal candidate will have over 10 years of...Senior- Bayer in the United States seeks a Senior Director, Licensing Officer to identify, shape... ...strategic collaboration deals. You will lead cross‑functional teams, negotiate term sheets... ...deal experience and the ability to build external partnerships across biotech, pharma and...Senior
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