Compliance and Quality Assurance Consultant

Job not on LinkedIn

🔥 0 minutes ago

🌐 Sweden, Croatia – Remote

🇸🇪 Sweden – Remote 🇭🇷 Croatia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• Support management of compliance and quality assurance-related projects • Provide consulting and contract services to clients addressing quality and GMP issues • Represent the company in assigned areas of quality assurance and regulatory / GxP • Manage and undertake client MIA / WDA projects and ProPharma MIA license work, as applicable, including QP batch certification, GxP auditing, and QMS development • Monitor regulatory and technological changes in the CQA field and develop subject matter expertise • Contribute to risk-based and phase-appropriate GxP projects • Participate in the sales process and identify scope and effort required to address client needs • Support marketing through social media content and blog development • Promote continual improvement in customer satisfaction regarding CQA consulting services • Provide CQA-specific training to clients and associates in other business units • Support clients and ProPharma functional units when GxP issues, deviations, and non-conformances arise • Consult on implementation of CAPA to resolve deviations and non-conformances • Ensure company operations comply with quality principles • Participate in development of quality systems through SOP writing and training • Engage employees at all levels to educate them on compliance and quality assurance and drive continuous improvement • Maintain a percentage of billable project work determined quarterly • Function as QP / RP / RPi for EU or UK clients, as applicable • Potentially serve as QP for the ProPharma MIA License • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree, or similar college degree, in a scientific discipline as a minimum • A graduate degree (MSc / PhD) in a scientific discipline is preferred • As applicable, eligible to be registered as a Qualified Person (QP) and Responsible Person (RP) • Minimum 5-8 years relevant experience in quality assurance and regulatory / GxP compliance • As applicable, previous registration as a Qualified Person would be preferred • Strong working knowledge of GxP principles including the Code of Federal Regulations (CFRs) and EU GMP / GDP regulations • GMP auditing experience would also be preferred • Fluent in English and Swedish (or another EU language) • Knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents • Expertise in GxP systems and capable of providing consultation based on previous experience and system knowledge • Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and execution of a project • Willingness and ability to travel as required • Ability to manage and execute multiple tasks within compliance, quality assurance, and relevant Quality and Compliance Consulting services • Quality orientation and high attention to detail • Strong analytical skills • For primarily audit-focused CQA Consultant roles, recent auditing experience is required: at least 5 audits performed in the past year as reflected in the candidate’s audit log

🏖️ Benefits

• Permanent position • Hybrid working encouraged for new hires based within a reasonably short commute of a ProPharma office, with time working from the office as agreed with the manager • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion • Safe and empowering workplace where employees can be their authentic selves • Applications personally reviewed by a recruitment team • No AI screening tools used in the hiring process • Applicants receive an outcome to their application