Quality Compliance Specialist, Post Market Surveillance

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

📋 Description

• Oversee the intake, investigation, and resolution of complaints from customers and partners regarding prescription products.

• Conduct independent investigations, document findings, and communicate complaints to customers and pertinent stakeholders.

• Ensure the accuracy of complaint details, including order IDs and pharmacy/compounder attribution.

• Assess and route complaints to the appropriate third parties based on the description and location of the complaint.

• Review investigations from third-party pharmacies and evaluate the adequacy of root cause analyses.

• Request re-investigation when findings do not meet established quality standards.

• Assess regulatory reportability under 503A/503B classifications and relevant FDA reporting obligations.

• Hold third-party pharmacies responsible for providing complaint closure summaries and investigation reports.

• Monitor contractual and regulatory deadlines, proactively escalating cases at risk of non-compliance.

• Identify and analyze trends in complaints across various categories, such as packaging, cold chain, and dosage.

• Suggest process improvements based on findings from complaint trend analysis.

• Generate regular metric reports for senior leadership that encompass complaint trends, root cause analyses, and action plans.

• Organize and facilitate cross-functional meetings involving customer experience, pharmacy operations, R&D quality, medical affairs, supplier, and strategic quality teams.

• Review and validate findings from third-party complaint investigations.

• Determine outcomes of complaint investigations without requiring case-by-case approval from the Director.

• Leverage pharmacy expertise to drive workflow modifications and enhancements in product quality.

⛳️ Requirements

• Preference for candidates working in the EST time zone.

• Active Pharmacy Technician or Pharmacist license is preferred.

• A Bachelor’s degree in a relevant field such as science, quality, or engineering is preferred; however, an associate degree with equivalent experience will be considered.

• A minimum of 4 years of experience in pharmacy operations, quality assurance, or complaint handling within 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 standards and non-sterile compounding processes.

• Exceptional oral and written communication skills.

• Experience with complaint or case management platforms, such as Zendesk.

• Capability to manage multiple ongoing investigations concurrently while ensuring documentation accuracy.

• Strong analytical skills to recognize trends and root causes within complaint data.

• Ability to juggle multiple tasks and meet deadlines in a fast-paced, remote-friendly healthcare setting.

• High level of accountability combined with a collaborative, team-oriented approach.

• Commitment to patient safety and adherence to rigorous quality standards.

• Pharmacy expertise to advocate for workflow changes and product enhancements concerning customer safety and satisfaction.

🏝️ Benefits

• Competitive salary.

• Equity compensation available for full-time positions.

• Unlimited paid time off (PTO).

• Company-paid holidays.

• Quarterly mental health days.

• Comprehensive medical, dental, and vision benefits.

• Parental leave.

• Employee Stock Purchase Program (ESPP).

• 401(k) benefits with employer matching contributions.

• Offsite team retreats.

• Talent-first approach with flexible and remote work options.