Senior Compliance and Quality Assurance Consultant

ProPharma

. Serve as a key subject matter expert in assigned areas of quality assurance and regulatory/GxP .

Posted 9/29/2026full-timeRemote • GermanySeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Assurance and regulatory compliance within GxP settings, with a strong focus on project management, client consultation, and training. Proficient in navigating the regulatory landscape and ensuring adherence to quality principles while promoting continual improvement in customer satisfaction.

Highest-signal resume keywords

Quality Assurance ExpertiseQualified Person ExperienceRegulatory Compliance KnowledgeProject Management SkillsGxP Auditing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System DevelopmentGxP AuditingSOP WritingCAPA ImplementationRisk-Based GxP ProjectsMIA/WDA Project ManagementQP Batch CertificationRegulatory Landscape UnderstandingClient ConsultationTraining Development

Soft Skills

Collaboration SkillsStakeholder ManagementCustomer Satisfaction FocusIndependent ConsultationPrioritization Skills

Industry Keywords

GxPUS FDAICHEMAMHRAQuality PrinciplesCommercial ProcessesDeviationsNon-ConformancesContinual Improvement

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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