Jobs at ProPharma

Supports deviation investigations for biotech, medical device, and pharmaceutical clients. Responsibilities include attending site meetings, collaborating with subject matter experts, conducting root cause investigations, creating CAPAs and effectiveness checks, coordinating deviation review boards, communicating progress, and routing records for approval. Requires quality control laboratory experience, strong technical writing and communication skills, effective time management, and at least five years of relevant experience.

Provides quality assurance support for quality control laboratories by completing training, reviewing and approving laboratory methods, and communicating barriers to ensure timely approvals. The role requires expertise in method review, approval, transfer, and validation, with LabVantage experience preferred. This is a 12-month contract role supporting pharmaceutical, biotech, or medical device programs.

Lead business development efforts to sell CRO and FSP solutions: build client relationships, generate leads, write proposals, negotiate contracts, coordinate with internal teams, attend conferences, and track opportunities in CRM to grow revenue.

Design, build, and maintain the enterprise Power BI reporting ecosystem—creating semantic models, dashboards, and certified datasets. Lead BI governance, optimize DAX and report performance, implement deployment/version control, collaborate with data engineers and stakeholders, monitor adoption, train users, and mentor junior BI developers.

Serve as the site Responsible Person for the Controlled Drugs Licence, ensuring compliance with Home Office requirements. Oversee procurement, storage, supply, transport, record-keeping, destruction, audits, investigations, licence maintenance, supplier qualification, and regulatory inspection readiness. Provide pharmacy expertise for sourcing and medicines procurement and maintain governance, SOPs, and stakeholder relationships.

Support global Quality & Compliance by assembling data packets, documenting requirements, creating design specifications, configuring LabVantage LIMS, and verifying configurations against approved specs in a GxP-regulated environment. Collaborate with developers, configuration specialists, and stakeholders to resolve defects and maintain validation and quality documentation.

Contract QA support for QC representatives responsible for timely completion of QA training, reviewing and approving laboratory methods, and ensuring communication when barriers arise. Role requires experience with method review/approval, method transfer/validation, and LabVantage. Strong communication and time-management skills expected to ensure prompt method reviews and approvals in a QC laboratory environment.

Provide deviation investigation support for QC laboratory events: attend site meetings, perform root cause analysis, create CAPAs and effectiveness checks, route records for review/approval, and own deviation records through closure. Complete required training and communicate progress to stakeholders, leveraging LIMS and quality systems.

The GXP Auditor will provide auditing expertise to ensure compliance with regulatory standards in biotech, medical device, and pharmaceutical sectors.

Lead and perform pharmacovigilance benefit-risk activities including authoring and quality-review of aggregate safety reports (PSURs/PBRERs, PADERs, DSURs), RMPs, and signal management reports; conduct literature screening and data extraction; generate and QC line listings; mentor staff; support audits/inspections; liaise with clients and ensure timely, regulatory-compliant deliverables.

Serve as strategic QA/RA advisor to build GMP readiness: assess platform roadmap, recommend launch path, define design controls and validation (DQ/IQ/OQ/PQ), refine 21 CFR Part 11 approach, implement a lean QMS across instruments/consumables/software, advise on eQMS, and shape organizational quality/regulatory strategy. May perform hands-on documentation, SOP drafting, QMS implementation, and customer-facing quality leadership.

Coordinate and maintain study data in CTMS and GoClinical, manage site communications and document submissions, support decentralized visit logistics, track inventory and shipments, assist with study documents, training, audits, metrics, meeting minutes, and study closeout activities as directed by the GCPM.

Lead statistical activities for clinical trials including design, SAP development, and analysis. Provide statistical expertise to cross-functional teams, ensure quality of statistical deliverables (reports, tables, listings, graphs), develop and maintain SAS programs, ensure regulatory compliance, support protocol/CRF development, mentor junior statisticians, and contribute to SOP/process improvements.

Serve as a Subject Matter Expert in quality assurance and regulatory/GxP for biotech, device, and pharma clients. Manage and consult on CQA projects, ensure project profitability, lead audits, develop QMS and CAPA solutions, support sales and marketing as SME, deliver training, and maintain billable utilization while promoting continual improvement and regulatory compliance.

The VP of Advertising & Promotional Review leads compliance and regulatory advisory services, manages promotional review processes, and collaborates with C-suite executives in pharmaceutical and biotech sectors.

Conduct audits in life sciences, focusing on quality, compliance, and regulatory requirements. Plan, execute, and report findings with client engagement and follow-up actions.

The GCP Compliance & QA Consultant will manage quality assurance projects, ensure compliance with regulations, provide training, and support marketing efforts while promoting customer satisfaction.

Lead and coordinate project execution for facility commissioning, qualification, and turnover to achieve occupancy and operational readiness. Maintain integrated schedules, project controls, risk and issue logs, and stakeholder communications. Facilitate governance meetings, escalate issues, and produce leadership updates. Use cell and gene therapy processing knowledge to identify risks and support CQV and EMPQ activities.

Manage individual safety case reports (clinical trial and post-marketing), assess seriousness and expectedness, perform MedDRA coding, write medical narratives, follow up for missing information, submit expedited reports per regulations, perform peer reviews, and support training and client notifications.

Senior QA & Compliance consultant providing SME support for Blood & Plasma investigational and commercial products across the EU. Duties include QP-related activities (batch certification), GxP auditing, QMS development, GDP/Responsible Person duties, risk assessments, client training, project delivery and profitability, and promoting CQA services while keeping regulatory knowledge current.