Senior Compliance and Quality Assurance Consultant

This is a fully remote position, open to applicants in Germany.

📋 Description

• Act as a primary subject matter expert in designated areas of quality assurance and regulatory/GxP.

• Offer independent consultation and lead projects within CQA initiatives.

• Oversee and manage client MIA/WDA projects and PPG MIA licensing activities, which include QP batch certification, GxP auditing, and the development of Quality Management Systems (QMS).

• Ensure the effective execution and profitability of critical projects.

• Keep abreast of regulatory and technological advancements in the CQA sector.

• Contribute to risk-based and phase-appropriate GxP projects.

• Serve as a subject matter expert in commercial processes, determining the scope and effort required to meet client needs.

• Advocate for CQA services throughout the industry.

• Foster continuous improvement in customer satisfaction.

• Deliver CQA-specific training for clients and colleagues.

• Assist clients and ProPharma functional units with GxP-related issues, including deviations and non-conformances.

• Provide consultation on CAPA implementation and support adherence to quality principles.

• Engage in quality system development through the writing of SOPs and training.

• Educate employees at all levels about compliance and quality assurance standards.

• Execute the role of Qualified Person or Responsible Person for clients, as needed.

• Carry out additional duties as assigned.

⛳️ Requirements

• Preferably possess at least a BSc degree in Pharmacy or a relevant field.

• Have a minimum of 10 years of experience in Quality Assurance within GxP environments.

• Hold 2–3 years of experience working as a Qualified Person.

• Ideally experienced in the development and marketing of products.

• Comprehensive understanding of the regulatory landscape, including US FDA, ICH, EMA, and MHRA guidelines.

• Proficiency in English and preferably one additional EU language.

• Proven project management abilities with strong skills in workload prioritization and deadline adherence.

• Excellent collaboration and stakeholder engagement skills.

🏝️ Benefits

• Opportunity for remote work.

• Competitive compensation package.

• Emphasis on a positive work-life balance.

• Hybrid working arrangements encouraged for new hires located within a reasonable commuting distance to an office.

• Commitment to being an Equal Opportunity Employer dedicated to diversity, equity, and inclusion.