Senior Compliance and Quality Assurance Consultant

🔥 0 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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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

• Serve as a key subject matter expert in assigned areas of quality assurance and regulatory/GxP • Provide independent consultation and project leadership across CQA projects • Lead and manage client MIA/WDA projects and PPG MIA license activities, including QP batch certification, GxP auditing, and QMS development • Ensure successful execution and profitability of key projects • Monitor regulatory and technological changes in the CQA field • Contribute to risk-based and phase-appropriate GxP projects • Act as SME in commercial processes and identify scope and effort required for client needs • Promote CQA services across the industry • Promote continual improvement in customer satisfaction • Provide CQA-specific training to clients and associates • Support clients and ProPharma functional units with GxP issues, including deviations and non-conformances • Consult on CAPA implementation and support compliance with quality principles • Participate in quality-system development through SOP writing and training • Educate employees at all levels on compliance and quality assurance • Perform the Qualified Person or Responsible Person function for clients, as applicable • Perform other duties as assigned

🎯 Requirements

• Ideally educated to at least a BSc level in Pharmacy or another appropriate discipline • 10 years or more experience within Quality Assurance within GxP settings • 2–3 years or more experience working as a Qualified Person • Ideally skilled in development and marketed products • Thorough understanding of the regulatory landscape, including US FDA, ICH, EMA, and MHRA • Fluency in English and ideally one other EU language • Demonstrated project management skills with the ability to prioritise workload and meet deadlines • Excellent collaboration and stakeholder skills

🏖️ Benefits

• Remote working opportunity • Competitive remuneration package • Positive work-life balance • Hybrid working encouraged for new hires based within a reasonably short commute of an office • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion