Quality Compliance Specialist, Post Market Surveillance

Jobtailor; Deutschland; Remote; EUR 52.000 - 78.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced Complaint Investigator in Germany to manage intake, investigation, and resolution of complaints related to prescription products. You will independently document findings, verify details like order IDs and attribution, and route cases to appropriate partners while ensuring regulatory standards are met.

The role requires pharmacy operations experience, familiarity with 503A/503B regulations, and strong communication skills.

Qualifikationen

• 4+ years of experience in pharmacy operations, quality assurance, or complaint handling in a regulated environment.
• Familiarity with 503A/503B compounding pharmacy regulations and FDA reporting requirements
• Knowledge of 21 CFR Parts 210/211, cGMP, and GDP practices
• Strong oral and written communication skills

Aufgaben

• Manage intake, investigation, and resolution of customer and partner complaints related to prescription products
• Independently investigate, document, and communicate complaints to customers and relevant stakeholders
• Review complaint details for accuracy, including order IDs and pharmacy/compounder attribution
• Triage and route complaints to appropriate third parties based on complaint description and location
• Evaluate third-party pharmacy investigations and assess root cause analysis adequacy
• Hold third-party pharmacies accountable for complaint closure summaries and investigation reports
• Track contractual and regulatory deadlines and elevate at-risk cases proactively
• Identify and analyze complaint trends across categories such as packaging, cold chain, and dosage
• Recommend process changes based on complaint trend findings
• Create regular metric reports for senior leadership covering complaint trends, root cause analysis, and action plans
• Organize and lead cross-functional meetings with customer experience, pharmacy operations, R&D quality, medical affairs, supplier, and strategic quality teams
• Review and concur on third-party complaint investigation findings
• Determine complaint investigation outcomes without case-by-case approval from the Director
• Use pharmacy expertise to influence workflow changes and product improvements related to customer safety and satisfaction

Kenntnisse

Complaint Management

Regulatory Compliance

Analytical Skills

Cross-Functional Collaboration

Trend Analysis

Ausbildung

Bachelor’s degree in science/quality/engineering

Tools

Zendesk

Jobbeschreibung

• Manage intake, investigation, and resolution of customer and partner complaints related to prescription products
• Independently investigate, document, and communicate complaints to customers and relevant stakeholders
• Review complaint details for accuracy, including order IDs and pharmacy/compounder attribution
• Triage and route complaints to appropriate third parties based on complaint description and location
• Evaluate third-party pharmacy investigations and assess root cause analysis adequacy
• Require re-investigation when findings do not meet quality standards
• Determine regulatory reportability under 503A/503B classifications and applicable FDA reporting requirements
• Hold third-party pharmacies accountable for complaint closure summaries and investigation reports
• Track contractual and regulatory deadlines and elevate at-risk cases proactively
• Identify and analyze complaint trends across categories such as packaging, cold chain, and dosage
• Recommend process changes based on complaint trend findings
• Create regular metric reports for senior leadership covering complaint trends, root cause analysis, and action plans
• Organize and lead cross-functional meetings with customer experience, pharmacy operations, R&D quality, medical affairs, supplier, and strategic quality teams
• Review and concur on third-party complaint investigation findings
• Determine complaint investigation outcomes without case-by-case approval from the Director
• Use pharmacy expertise to influence workflow changes and product improvements

Requirements

• Preferably work in the EST time zone
• Active Pharmacy Technician or Pharmacist license preferred
• Bachelor’s degree in a relevant science, quality, or engineering field preferred; or an associate degree with equivalent experience will be considered
• 4+ years of experience in pharmacy operations, quality assurance, or complaint handling in a regulated environment
• Familiarity with 503A/503B compounding pharmacy regulations and FDA reporting requirements
• Knowledge of 21 CFR Parts 210/211, cGMP, and GDP practices
• Understanding of USP <795> and <800> standards and non-sterile compounding processes
• Strong oral and written communication skills
• Experience with complaint or case management platforms such as Zendesk
• Ability to manage multiple open investigations simultaneously while maintaining documentation accuracy
• Excellent analytical skills to identify trends and root causes across complaint data
• Ability to manage multiple tasks and meet deadlines in a fast-paced, remote-friendly healthcare environment
• High sense of accountability and a collaborative, team-oriented mindset
• Commitment to patient safety and rigorous quality standards
• Pharmacy expertise to influence workflow changes and product improvements related to customer safety and satisfaction

Core Competencies

Demonstrates expertise in complaint management and resolution within pharmacy operations, ensuring compliance with regulatory standards such as 503A/503B and FDA requirements. Proficient in analyzing complaint trends and leading cross-functional teams to enhance product quality and customer satisfaction.

Highest-signal resume keywords

• Pharmacy Technician License
• Complaint Management
• Regulatory Compliance (503A/503B)
• Analytical Skills
• Cross-Functional Collaboration

Hard Skills

• Complaint Investigation
• Root Cause Analysis
• Quality Assurance
• Documentation Accuracy
• Trend Analysis
• CGMP Knowledge
• FDA Reporting Requirements
• USP <795> and <800> Standards
• Pharmacy Operations
• Case Management Platforms

Soft Skills

• Strong Communication Skills
• Team-Oriented Mindset
• High Accountability
• Ability to Manage Multiple Tasks
• Commitment to Patient Safety

Certifications & Qualifications

• Active Pharmacy Technician or Pharmacist License

Industry Keywords

• Complaint Handling
• Regulated Environment
• Quality Standards
• Cold Chain
• Dosage
• Packaging
• Healthcare Environment
• Fast-Paced Work
• Contractual Deadlines
• Cross-Functional Meetings

Tools & Technologies

• Zendesk