Biotechnology Jobs

420 jobs for “Pharmaceutical Quality Assessor”

Results

GSK logo

GSK · 10000+ people · Public

Associate Director, Diagnostic Planning Lead - Oncology

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  • Stevenage
  • Hybrid · 2–3 days in office
  • US$151,500 – US$252,500 pa
  • Director

Leads cross-functional project teams within Oncology Translational Medicine to progress diagnostic and biomarker development activities, coordinating with clinical, regulatory, quality, finance and external lab partners. Builds integrated timelines, tracks budgets, milestones and contracts, mitigates risks, and supports regulatory submissions and technical evaluations of diagnostic technologies.

Microsoft Project · Microsoft Word · Microsoft Excel +7

Last week
GSK logo

GSK · 10000+ people · Public

Director, Real-World Evidence & Health Outcomes, mRNA Vaccines

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  • Philadelphia, United States
  • US$203,775 – US$339,625 pa
  • Director

Provides scientific and strategic leadership for real-world evidence supporting an mRNA vaccine portfolio, with a primary focus on influenza. Shapes evidence generation across late-stage development, launch and post-marketing, leading US post-marketing vaccine effectiveness studies and external academic and data-partner collaborations. Requires deep expertise in influenza epidemiology, real-world data and causal methods, plus influence across a global matrix.

Medicare · EHR

2 weeks ago

Parexel

Principal Clinical Database Programmer - eCOA

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  • Sheffield
  • Remote
  • Lead

Configures, tests and maintains electronic Clinical Outcome Assessment studies in platforms such as Medidata Designer eCOA, translating protocols and licensed instrument requirements into questionnaires, schedules and branching logic. Acts as technical contact for sponsors and vendors, coordinates eCOA-to-EDC integration and deployment, and mentors less-experienced study designers across multiple global trials.

Medidata Designer eCOA · Medidata Rave

6 days ago

AstraZeneca · 10000+ people · Public

Senior International Regulatory Affairs Director

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  • Cambridge
  • Hybrid · 3 days in office
  • Director · manages people

Owns International regulatory strategy for complex cell therapy programs, embedding regional requirements into evidence generation, submissions and labeling. Leads BLA/MAA planning, Health Authority engagements and labeling negotiations, integrating clinical, CMC, safety and commercial input. Also leads a matrix regulatory team, coaching colleagues and shaping policy and process improvements.

BLA · MAA · IND +2

6 days ago

Moderna · 1001–5000 people · Late stage

Scientist, Genetic Assays

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  • Oxford
  • On-site
  • Senior

Sole-contributor scientist role developing and executing biochemical and molecular biology assays for PK/PD analysis, spanning genomic DNA/RNA isolation, qPCR, ddPCR, RNA sequencing, MSD, ELISA and immunoblotting. Works within Moderna's Clinical Bioanalytical team at Harwell, Oxfordshire, ensuring GcLP-compliant assay qualification and validation, troubleshooting with external CRO partners, and building internal and external mRNA-based bioanalytical capability.

MSD · LIMS · eLNB +1

Last month

Autolus · 101–500 people · Series C

Senior Engineer, CSV Validation

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  • Stevenage
  • Hybrid
  • Senior

Hands-on senior role owning the computerised-system lifecycle for GxP systems, from impact and supplier assessments through validation, release, operation and retirement. Authors and executes CSV documentation, performs data integrity and 21 CFR Part 11 assessments, manages change controls and CAPAs, and supports regulatory inspections as a CSV subject matter expert.

SaaS · Cloud

3 months ago

Moderna · 1001–5000 people · Late stage

Automation Engineer – Packaging & Process Automation

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  • Oxford
  • On-site
  • Mid-level

Hands-on automation engineering role supporting drug product packaging and drug substance manufacturing at a new mRNA facility. Involves commissioning and optimising Emerson DeltaV and Allen-Bradley/Rockwell PLC systems, automated labelling and secondary packaging equipment, plus GxP validation, root cause analysis and lifecycle documentation. Works independently as a technical specialist across manufacturing, engineering, quality and digital teams.

Emerson DeltaV · Allen-Bradley · Rockwell Automation +7

Clearance required 2 weeks ago

AstraZeneca · 10000+ people · Public

Frontier AI Research Principal

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  • Cambridge
  • Lead · manages people

Lead multidisciplinary teams defining and delivering AstraZeneca's frontier AI roadmap, turning ambiguous scientific and business questions into scalable AI/ML and agentic systems deployed on cloud and HPC. The role spans problem framing, MLOps, governance and external partnerships, with a strong emphasis on reuse, adoption and measurable scientific impact.

Python · PyTorch · JAX +7

Yesterday

Ipsen

Senior Manager, Data Transparency & Regulatory Disclosure

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  • London
  • Hybrid
  • Senior

Leads global clinical data transparency and disclosure across registries and regulatory platforms such as CTIS, EMA Policy 0070 and Health Canada PRCI, acting as subject matter expert for assigned therapeutic areas. Manages vendor partnerships, FOI access requests, redaction and lay summary work, plus SOP governance, compliance reporting and audit readiness within Global Regulatory Affairs Excellence.

CTIS · ClinicalTrials.gov · EU Clinical Trial Register +3

Last week

Gilead Sciences

Assoc Director, R&D Information Systems

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  • Cambridge
  • Director · manages people

Leads end-to-end Clinical Systems migration initiatives such as CTMS, eTMF and study startup, from strategy and due diligence through implementation, cutover and legacy decommissioning. Oversees data migration programs, CRO integrations and GxP validation, managing vendors, stakeholders and a team of professionals while shaping the Clinical Systems roadmap.

CTMS · eTMF

3 weeks ago

Parexel

Executive Director, Biostatistics Scientific Advisory

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  • London
  • Remote
  • Director

Provides statistical consulting and strategic advice on optimal study designs and analyses across drug, device, and diagnostic clinical development, including preparation for regulatory authority interactions. Serves as a leader in innovative study designs for client accounts and supports new business through proposals, bids, and client presentations, representing clients at key regulatory meetings.

FDA · EMEA · MHRA +2

2 weeks ago

Gilead Sciences

Associate Director, Regulatory AI Capability Lead

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  • Cambridge
  • Director

Leads business process mapping, design and optimisation across CMC Regulatory Affairs, from development and registration through post-approval lifecycle management. Partners with IT, data owners and cross-functional teams to translate regulatory needs into digital, automation and AI use cases, then drives implementation, adoption and KPI measurement. Distinct for combining regulatory operations expertise with AI-enabled capability building in a global matrixed pharma environment.

Veeva Vault · Planisware · Signavio +2

Last month

Ipsen

Clinical Research Pharmacy Services Lead

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  • London
  • Hybrid
  • Lead · manages people

Serves as the clinical trial pharmacy subject matter expert across global oncology programmes, advising on investigational product handling, preparation, storage and accountability, and on hazardous drug and CSTD requirements. Develops pharmacy manuals and training for site pharmacists and study teams, supports audits and CAPAs, and oversees FSP pharmacists and external vendors. Hybrid role spanning London, Paris or Cambridge MA.

Closed System Transfer Devices

Last month

Danaher

Medical Director, Companion Diagnostics and Advanced Assays

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  • Newcastle upon Tyne
  • Hybrid
  • Director

Provides medical and clinical leadership for the development of novel diagnostic and companion diagnostic assays and platforms supporting precision medicine. Acts as subject matter expert for R&D projects, clinical studies and regulatory submissions, and supports pharma partnerships and pathology education. Hybrid role based in Newcastle Upon Tyne with 30-40% international travel.

IVD · CDx · Digital Pathology

Last month

Thermo Fisher Scientific

QC Section Head

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  • Swindon
  • Lead · manages people

Leads a team of scientific officers performing GMP QC Chemistry analysis of incoming goods, in-process, intermediate, stability and finished product samples. Acts as first escalation point for technical, compliance and personnel issues, manages batch release, stability studies, documentation and audits, and deputises for the QC Manager. Requires extensive instrumental and traditional analytical experience plus 2+ years of team leadership.

3 months ago

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