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.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior QA Lead, External CMOs - GMP Compliance in Basking Ridge, NJ vacancy
$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$149.16k - $223.74k
...in EuropeAreas Managed: QA operations oversighting Manufacturing External Supply Organization (ESO)OverviewThe QA Director GMP ESO Biotechnologies is responsible... ...objective is to ensure compliance of these activities with... ...of Change Control from CMOs with implementation in...SuggestedTemporary workWork at officeLocal areaNight shiftWeekend work3 days per week$120k - $150k
...QA Product Manager (Sterile Products)The... ...safety, and regulatory compliance of sterile... ...manufactured by third-party CMOs. This position... ...internal teams and external manufacturers to ensure... ...validation.Lead the Quality Assurance... ...understanding of global GMP and regulatory...SuggestedFull timeWork at officeLocal areaShionogi Inc.
Florham Park, NJ3 days ago- ...Florham Park, NJ is seeking an experienced communications leader to develop and execute external communications strategies that align with business goals and market priorities. You will lead a broad media relations program across AI, technology, business, financial, and...Senior
- ...Somerset, NJ facility. You will drive EHS programs, ensure regulatory compliance, and support production, labs, warehouse, and maintenance with... ...investigations, training, and cross-functional collaboration to maintain a safe GMP environment. #J-18808-Ljbffr BioSpaceSeniorShift workNight shift
- ...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
- ...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...
- Legend Biotech seeks a QA Investigations Lead I to oversee quality investigations in Raritan, NJ. This role involves ensuring robust investigations in a GMP environment, supporting regulatory compliance, and collaborating with various teams. The ideal candidate holds a...
- ...an Environmental Health and Safety (EHS) Sr. Specialist for the third shift at our New Jersey GMP cell therapy facility. You will drive EHS culture, ensure regulatory compliance, and support site programs across Environmental, Health, and Safety functions; collaborate...SeniorShift 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$68.05k - $109.87k
...Legend Biotech is seeking QA Investigations Lead I as part of the Quality team... ...product in a sterile GMP environment. The ideal candidate... ...audits as needed. Support compliance activities for site Quality... ...that arise with internal or external customers. Other Types of...Permanent employmentFull timeTemporary workFor contractorsWork experience placementLocal areaWorldwideFlexible hours- ...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
- Pyramid Consulting, Inc. is seeking a talented QA Test Analyst for a 6-month contract to hire in Morristown, NJ (Hybrid). The role focuses on testing methodologies, test planning, and data validation within the healthcare domain. You will develop test plans, strategy,...SeniorContract work
$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- ...With a focus on scalability, compliance, and innovation, Zeta empowers... ...2024 Sparrow , the leading card experience for non-prime... ...the governance calls with the senior client counterparts. Platform... ...interpersonal skills especially with external stakeholders Rigorous...Senior
$153.6k - $230.4k
...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...Local areaWorldwide- ...support for U.S. promotional materials across the Daiichi Sankyo portfolio. You will review materials for FDA compliance, provide risk-based guidance, and lead cross-functional review discussions to ensure timely, compliant communications. The role requires 7+ years in...Senior
- ...Pharmaceutical, Inc. in the United States, seeks a Regulatory Affairs Senior Associate to manage regulatory submissions (ANDAs and post-... ...packages under GDUFA III, coordinate with internal teams and external partners, and contribute to development from early formulation...Senior
- ...Accounting Manager to oversee core accounting functions, ensure GAAP compliance, and support the monthly close and financial reporting. This role collaborates with Shared Services, FP&A, and external auditors to maintain accurate books and robust internal controls. You...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
- Dun & Bradstreet is seeking a Senior External Communications Manager to lead strategic media relations and external communications efforts, translating complex data into compelling narratives for diverse audiences. This highly visible role partners with senior leaders...Senior
- ...payroll mailbox, and employment verification. You will resolve pay discrepancies and deliver exceptional service to internal and external customers. This hybrid role requires 4 days in-office at our Whippany, NJ location and 1 day remote, with ongoing collaboration with...SeniorWork at officeRemote work
- A recruitment firm is seeking a Senior Internal Auditor in Basking Ridge, NJ, to lead operational and compliance audits, evaluate internal controls, and enhance operational efficiency. Ideal candidates will have a degree in Accounting or Finance and 4-7 years of relevant...SeniorFull time
$242.7k - $404.5k
Daiichi Sankyo US is looking for a Senior Director, Clinical Safety Science to lead global safety strategy across the product lifecycle. This key role oversees a team of Safety Scientists and collaborates with various stakeholders for proactive safety surveillance and...Senior- Dun & Bradstreet is seeking a Senior External Communications Manager to lead strategic media relations and external communications initiatives. This role focuses on translating complex data into compelling narratives for diverse audiences. Candidates should have a strong...Senior
- A leading pharmaceutical company in Morristown, NJ, is seeking an External Supply Operations Sr. Manager to oversee supplier relationships and ensure reliable product supply. The ideal candidate will possess strong communication skills, a background in supply chain management...SeniorFull time
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior QA Lead, External CMOs - GMP Compliance. Be the first to apply!
Related searches
- senior leadership Basking Ridge, NJ
- senior manager automotive Basking Ridge, NJ
- senior magento developer Basking Ridge, NJ
- senior application administrator Basking Ridge, NJ
- senior java full-stack developer Basking Ridge, NJ
- senior accountant work from home Basking Ridge, NJ
- senior manager accenture Basking Ridge, NJ
- senior director digital marketing Basking Ridge, NJ
- senior performance engineer Basking Ridge, NJ
- senior tech Basking Ridge, NJ