Senior Manager, Small Molecule CMC Compliance & Inspection Readiness
Creative Solutions Services, LLC
Biotechnologist Associate Job Description The Manufacturing Associate is responsible for supporting the production of therapeutic proteins (API) in a cGMP-regulated environment. This role involves operating equipment, executing manufacturing processes, performing basic laboratory tasks, and maintaining compliance with GMP and safety standards while working in a cleanroom environment. Responsibilities: Ope... 03/17/2026 26-00409 Portsmouth, NH Human Resources Business Partner Job Description The HR Business Partner will have responsibility to drive short term HR objective for INB and SPM assets in Portsmouth. Acts as key HR lead on asset leadership teams for both assets. Key deliverables include effective talent acquisition, employee relations, talent development and organizational management. Facilitates implementation and execution of Human Resource policies, ini... 03/17/2026 26-00408 Portsmouth, NH QC Specialist II Job Description The Quality Control Technical Transfer Analyst 3 supports the QC department by performing analytical testing, assisting with technical transfer activities, and maintaining quality documentation in a GMP-regulated pharmaceutical or biotechnology environment. The role involves executing laboratory testing, reviewing data, supporting validations and investigations, and ensuring co... 03/17/2026 26-00407 Portsmouth, NH Roles & Responsibilities: Serve as R&D Lead Serve as R&D Lead on New product development and product engineering initiatives focused on changes to existing products and design changes. Guides the successful completion of major programs and may function in project leadership role. Independently determines and develops approach to solutions. Represents the organization as the prime t... 03/13/2026 26-00406 Franklin Lakes, NJ Digital Marketing Executive Job Description We are looking for a creative and results-driven Digital Marketing Executive to join our team and help grow our online presence. Qualification: Bachelor's degree in marketing, Business, or related field. Key Skills: SEO & Digital Marketing Campaigns. Google Ads & Meta Ads Management. Social Media Content & Scheduling. ... 03/13/2026 26-00405 Vijayawada, Andhra Pradesh Digital Marketing Executive Job Description We are looking for a creative and results-driven Digital Marketing Executive to join our team and help grow our online presence. Qualification: Bachelor's degree in marketing, Business, or related field. Key Skills: SEO & Digital Marketing Campaigns. Google Ads & Meta Ads Management. Social Media Content & Scheduling. ... 03/13/2026 26-00404 Guntur, Andhra Pradesh Digital Marketing Executive Job Description We are looking for a creative and results-driven Digital Marketing Executive to join our team and help grow our online presence. Qualification: Bachelor's degree in marketing, Business, or related field. Key Skills: SEO & Digital Marketing Campaigns. Google Ads & Meta Ads Management. Social Media Content & Scheduling. ... 03/13/2026 26-00403 Narasaraopet, Andhra Pradesh Test/NPI engineer with a strong mechanical engineering background Job Description The ideal candidate will be responsible for designing, developing, implementing, and supporting test solutions for manufacturing and operational processes. This includes automated test systems, diagnostics, calibration, and verification tools to ensure the quality and reliability of products during production. Responsibilities: Design and develop production test s... 03/12/2026 26-00402 Irvine, CA Validation Engineer, Senior Job Description We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled tempera... 03/12/2026 26-00401 Marietta, PA Validation Engineer, Senior Job Description We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled tempera... 03/12/2026 26-00400 Upper Providence, PA Validation Engineer, Mid-Level Job Description We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled tempera... 03/12/2026 26-00399 Marietta, PA Validation Engineer, Mid-Level Job Description We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled tempera... 03/12/2026 26-00398 Upper Providence, PA Validation Specialist, Senior Job Description We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled tempera... 03/12/2026 26-00397 Marietta, PA Validation Specialist, Senior Job Description We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled tempera... 03/12/2026 26-00396 Upper Providence, PA Validation Specialist, Mid-Level Job Description We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled tempera... 03/12/2026 26-00395 Marietta, PA Validation Specialist, Mid-Level Job Description We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled tempera... 03/12/2026 26-00394 Upper Providence, PA Sr Validation Specialist Job Description Our client is seeking an experienced Senior Validation Consultant to support critical quality and compliance initiatives within their manufacturing operations. This consultant will play a key role in validation and quality oversight across sterile and packaging processes, with a particular focus on visual inspection, parenteral syringes, and packaging operations.... 03/11/2026 26-00393 New York, NY Logistics Associate III Job Description Responsible for handling daily shipping, receiving, warehousing, and distribution activities. Ensures accurate order processing, smooth freight movement, and timely delivery. Supports management in logistics planning, purchasing, forecasting, and customer service coordination. Roles & Responsibilities: Manage daily shipping, receiving, and distribution operations.... 03/11/2026 26-00392 Portsmouth, NH Tech 1, Mechanical Engineering Job Description We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisors, project leaders, and other professionals in the unit. Responsibilities: Gathers, maintains, format... 03/11/2026 26-00391 Brea, CA Tech 2, Mechanical Engineering Job Description We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisors, project leaders, and other professionals in the unit. Responsibilities: Gathers, maintain... 03/11/2026 26-00390 Brea, CA #J-18808-Ljbffr Creative Solutions Services, LLC
- ...Responsibilities: Real-time Inspection Readiness. Develop, manage and contribute to ongoing... ...support inspection readiness. Small Molecule GMP Evidence to support GMP/GDP... ...activities as needed to support the SM CMC Compliance Team. uthor/Revise Standard...SeniorWork experience placement
$127k - $190.4k
...POSITION SUMMARY: The Senior Manager, GMP Inspection Readiness plays a key role in... ...multiple modalities, including Small Molecule, Cell & Gene Therapies,... ...expert in GMP quality, compliance, and quality systems,... ...broader support to the CMC Compliance Team ,...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week- ...clinical-stage biotechnology company is seeking a Senior Director of Quality Assurance GCP to develop a robust... ...role involves overseeing GCP audit programmes, managing quality events, and ensuring inspection readiness. Candidates should have a degree in life sciences,...Senior
$245k - $276k
...experienced team ready to take action because... ...Opportunity The Senior Director, External... ..., and small molecules. As Amylyx advances... ...product launches, manage increasing manufacturing... ...supply planning, and inspection preparedness... ...with Finance, Legal, CMC, Quality, and Supply...SeniorFull timeLocal areaRemote work$252k - $269k
Clinical Quality Assurance Senior Leader provides strategic leadership and... ...GCP/GVP quality programs to ensure compliance across global clinical trials. This... ...ensures the organization is ready for inspections, implements and manages risk-based quality systems, collaborates...SeniorLocal areaWorldwide$138.1k - $186.4k
...initiating a search for a Senior Electrical Engineer/... ...guidance to PMs and managers that address current and... ..., and future-ready opportunities. Provides... ...comprehensive investigations and inspections of proposed and... ..., codes, regulations, compliance practices, and record-...SeniorFor subcontractorWork at officeLocal areaFlexible hours$235k - $330k
...leading pipeline of oral small molecule degraders to provide... ...an impact: The Senior Director, Clinical... ...for overseeing and managing all aspects of... ...standards Ensure compliance with regulatory requirements... ...Accountable for inspection readiness and provides appropriate...SeniorLocal area- ...strategic and experienced Senior Director of... .... You will manage a small team of Regulatory... ...Clinical, Nonclinical, CMC, Biostatistics, Clinical... ...plans. Ensure compliance with applicable... ...requirements; maintain audit‑ready regulatory documentation and inspection readiness....SeniorWork at officeLocal area3 days per week
$156k - $316.5k
...Position Description The Senior Director, Regulatory CMC is responsible for... ...strong emphasis on lifecycle management, change management, and sustained regulatory compliance. This role provides... ...maintaining product supply and inspection readiness. The Senior Director...SeniorFull timeWork at officeFlexible hours3 days per week$150k - $160k
Responsibilities Lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance Create and process document change control (DCC) documentation... ...and experience supporting regulatory inspections 8+ years of industry experience 2+...SeniorShift work- ...reconditioning lines within the Inspection & Reconditioning Center (IC),... ...full working shift. Fully manage facilities to meet or exceed... ...performance reviews with Senior Reconditioning leadership, reporting... ...and processes. Ensure compliance with all health, safety and...SeniorRelocationShift work
$250k - $306k
...lives of patients we serve. Position Summary: The Senior Director, CMC Project Management i s responsible for leading and coordinating the strategic... ..., technology transfer, and GMP manufacturing ~ Small molecule and solid oral dosage form experience preferred. ~...SeniorFull timeImmediate startFlexible hoursShift work$170k - $180k
...radical care. SUMMARY The Senior Manager, QA Computer System... ...forQAoversight ofthe validation and compliance ofGxP-regulated... ...internal/external audits and inspections. QUALIFICATIONS * Bachelors... ...inspections with strong inspection-readiness skills. * Strong...SeniorFull timeWork at officeFlexible hoursShift work3 days per week$177k - $278.08k
...The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and... ...Supporting diverse modalities—including small molecules, biologics, and external... ...bundling of changes), ensuring compliance with global requirements. Apply...Minimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide$137.8k - $206.8k
Job Description General Summary: The Senior Manager, Clinical Study Quality Lead provides... ...to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable... ..., compliance trend analysis, and inspection readiness. The role partners closely with...SeniorFull timeSummer workRemote workFlexible hours2 days per week$155k - $175k
...immediate opportunity for a Senior Director,... ...Automation, and greenfield Small Commercial Claims platform... ...teams, lead project managers and ensure delivery excellence... ...transparency and compliance by evolving governance... ...excellence and future readiness. Qualifications,...SeniorTemporary workImmediate startFlexible hours- ...Experience in business development within the small molecule field of CDMO/Pharmaceutical/Biotech companies, familiarity with the CMC process, and general knowledge of API.... ...Budget control, revenue, and expense strategy management. Expand the profile and reach of the...Senior
$190.8k - $300.3k
...professionalism. Position Overview The Senior Principal Scientist, Regulatory... ...experience with both small and large molecule development programs Experience... ...Improvements Regulatory Affairs Compliance Regulatory Affairs Management Regulatory Communications Regulatory...SeniorFor contractorsWork at officeLocal areaRemote workWorldwideMonday to Friday3 days per week$150k - $190k
...exceptional construction project management solutions for clients, with a... ...Ensure adherence to safety, compliance, and quality standards... ...Applicant A successful Senior Project Manager- Life Science... ...industry. If you are ready to take the next step in your...SeniorFor contractorsLocal area$131.04k - $196.55k
...Senior Manager, GCP & GVP, QA At Agios, we are fueled by connections to transform rare... ...responsible for ensuring quality assurance and compliance of Agios Pharmacovigilance (PV)... ...compliance with GVP and GCP and inspection readiness. What you will do: Responsible...SeniorTemporary workRemote workWork from homeFlexible hours3 days per week$130.8k - $209.4k
...Regulatory Health Authority inspection planning, logistics, and supporting... ...inspections, ensuring compliance with Health Authority... ...sustained state of inspection readiness Here's What You'll Do... ...process. Coordinate and manage inspection readiness and preparation...SeniorPermanent employmentWork at officeLocal areaWork from home$144.38k - $240.63k
...Waltham Posted Date: May 26 2026 Senior Manager - CMC Regulatory Affairs Biopharm Development... ..., both internally (for increased compliance, harmonisation and efficiency) and externally... ...regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (...SeniorLocal areaWorldwide- ...Senior Software Engineering Manager, Product Security Boston, MA October 8, 2025 Deadline date: Job Description Build, lead... ...modeling. Oversee and drive WHOOP's engineering readiness for HIPAA compliance, coordinating technical implementation, evidence collection...Senior
$144.4k - $195.4k
...Overview: The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global... ...Regulatory classification considerations (e.g., small-molecule vs biologic paradigms) Manages regulatory compliance activities including periodic...SeniorFull timeTemporary workLocal areaFlexible hours$155k - $180k
Overview Senior Manager of U.S. Payroll - leads accurate, compliant payroll for a multi‑state... ...ensuring timely processing and supporting compliance and employee trust. Responsibilities... ...reconciliation, tax validation, and W‑2 readiness. Validate vendor payroll outputs prior...SeniorTemporary work$79k - $105k
...candidates for the position of Senior Project Manager in its Boston office. The... ...manage and mentor a small team of Project Managers and... ...documenting, and tracking compliance with green building rating... ...Performing construction site inspections to ensure that projects are...SeniorFull timeWork experience placementWork at officeLocal areaRemote workWork from homeNight shiftAfternoon shift2 days per week$175k - $185k
...FoundryCo, Inc. is seeking a Senior Accounting Manager/Director to lead our North America controllership... ...through reporting, controls, and compliance. The ideal candidate is technically... ...audits end-to-end, ensuring audit readiness and minimal disruption Maintain high...Senior$160k - $180k
...automated foundry for designing and building new organisms. Senior Engineer III, Small Molecules - High Throughput Screening & Technology Location:... ...solutions (RACs). Operational ownership & risk management Lead day‑to‑day operations of relevant workcells and walk...SeniorWork at office$115k - $145k
...& Key Functions: Provide management-level leadership, business process... ...compliant, effective, inspection-ready, and aligned with business needs... ...· Translate business and compliance needs into process and... ...preventive improvements. · For Senior Manager level: provide broader...SeniorFor contractors- ...and safety procedures duties as required. Manages and tracks supplies using computer-based... ...and lidocaine pre-mixed solutions. Inspects medical equipment such as defibrillators... ...Cleans and stocks spare ambulances to ensure readiness when needed. Maintains supplies (...SeniorShift work
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