Search the 25 jobs at ProPharma

Lead and coordinate QC projects, manage sample logistics, create and review documentation, ensure goods meet standards, support key initiatives, ensure compliance with guidelines.

Lead statistical activities for clinical trials and data analyses, provide expertise to cross functional teams, ensure quality and accuracy of statistical deliverables, develop and maintain SAS programs, stay updated with regulatory guidelines, mentor junior statisticians.

The Freelance/Contract Senior Process Engineer role at ProPharma involves supporting continuous improvement efforts within a GMP setting, providing leadership on CAPA's and deviations, managing processes, and working across the QA team to ensure quality operational tasks are completed successfully. The role requires further education in life sciences, experience in a GMP setting within the biological area, fluency in English, and the ability to work on a hybrid basis in Leiden, Netherlands.

Support continuous improvement efforts within a GMP setting, lead team members on CAPA's and deviations, manage processes and timelines, support QA team, and coach colleagues in GMP.

Assure complaint records meet global requirements, review and investigate non-medical complaint content, ensure compliance with regulatory requirements, interface with various stakeholders, provide quality customer service

The Quality Specialist position supports the delivery of Medical Information, Pharmacovigilance, and/or Clinical services, to assure ongoing compliance with quality and industry regulatory requirements. Essential functions include generating reports, analyzing deviations, developing corrective actions, and supporting audits.

Senior Manager role at ProPharma focusing on leading regulatory European CTA submission projects, managing client budgets, overseeing regulatory processes, and building client relationships. Requires advanced project management knowledge, strong attention to detail, and experience with clinical trial applications in Europe.

Seeking a Freelance/Contract Fachtechnisch verantwortliche Person (FvP) Consultant to work with clients in Switzerland on a key project. Responsibilities include ensuring license application success, compliance to regulations, running batch release activities, and stakeholder management. Must have a University degree in Science/Engineering, be a Responsible Person (FVP) in Switzerland, fluent in German and English, and have direct exposure to working with Biological projects as an FVP.

Principal Engineer responsible for managing and executing capital projects, overseeing construction and renovation activities, and ensuring compliance with safety regulations. Works closely with various departments and vendors to deliver high-quality infrastructure solutions. Manages project scopes, budgets, schedules, and stakeholder approvals. Provides contractor oversight, communicates project progress, and ensures projects are completed on time and within budget.

The Principal Biostatistician at ProPharma is responsible for leading statistical activities for clinical trials, providing statistical expertise to cross functional teams, ensuring quality and accuracy of statistical deliverables, and mentoring junior statisticians.

The Compliance and Quality Assurance Consultant (CQA) position is responsible for supporting the management of Clinical CQA related projects, providing Clinical quality consulting, Clinical quality technical writing, and contracted services to clients to address quality and regulatory/GCP issues as necessary. This position will be assigned quality assurance and regulatory/GxP compliance projects within the company.

Support the Annual Budget Process, perform complex analyses, act as a trusted business partner, drive communications to stakeholders, support M&A transactions, partner with functional teams, and prepare monthly KPIs.

Develop and optimize downstream processes for biological products, ensure compliance with regulatory requirements, provide technical and scientific support, collaborate cross-functionally, write technical documents, and support DSP activities.

ProPharma Group Sweden is hiring a Senior Regulatory Consultant to work on projects from various Pharmaceutical companies. Responsibilities include working on Regulatory Affairs, new registrations/variations, providing local regulatory advice, launch preparations, and collaborating with clients and colleagues. Qualifications include 5+ years of experience in Regulatory Affairs focused on Nordic regulations and an MSc in Pharmacy.

The Cash Application and Collection Team Lead role at ProPharma involves daily cash application, resolving discrepancies, auditing billing and customer set-up, and establishing relationships with customers. The ideal candidate should have strong analytical skills, customer service orientation, and experience with Workday ERP.

Responsible for planning and conducting GVP/GCP audits, acting as a Subject Matter Expert for clinical projects, managing clinical auditing program, and ensuring company compliance to GVP regulations. Also responsible for promoting continual improvement in customer satisfaction and supporting compliance issues within the pharmaceutical industry.

Seeking an independent CSV Engineer with DI experience for a freelance project lasting 12 months. Responsibilities include leading CSV activities, providing guidance on data integrity compliance, authoring validation deliverables, and acting as the subject matter expert in CSV. Must have a B.S./B.A. in Engineering, Science, Information Technology or related field, experience in CSV within the life-science industries, and fluency in English. Position is for a Hybrid approach in Ireland starting on July 1, 2024, for one year.

Seeking a CGT/ATMP Senior Consultant - Qualified Person with 10 years of experience in Biotech and ATMPs. Responsibilities include providing independent consultation on quality assurance and regulatory compliance projects in the Cell & Gene Therapy space. Must have knowledge of manufacturing techniques for cell and gene therapy products in a GMP regulated environment.

The GVP Auditor at ProPharma will lead clinical consulting and auditing projects, ensuring compliance with federal regulatory requirements and ICH guidance. Responsibilities include implementing a risk-based GVP audit program, providing oversight of the GVP consulting program, promoting customer satisfaction, staying updated on industry advancements, and supporting clients and company operations in clinical compliance issues.

The Multilingual Product Integrity Specialist (French) at ProPharma is responsible for evaluating data for product complaints and adverse events, coordinating product retrievals, performing follow-ups, and providing additional services for clients. The role requires excellent English and French language skills, knowledge of medical terminology, and the ability to multitask within strict timelines.