Sr. Quality Assurance Compliance Expert

Your Role:

This position supports the quality assurance organization by ensuring the sterile manufacturing facility follows EU regulation Annex 1 and other regulatory requirements. 

Responsibilities include but are not limited to:

• Lead and manage the development and execution of a robust remediation plan to address compliance gaps identified in EU regulation Annex 1 and other relevant regulations.
• Collaborate with cross-functional teams, including Quality Control, Regulatory Affairs, Manufacturing, and Engineering, to assess the current state of compliance and define corrective actions.
• Conduct thorough gap assessments and risk analyses to prioritize remediation efforts and develop effective strategies for addressing identified compliance gaps.
• Design and implement sustainable solutions that align with regulatory requirements and industry best practices, while also considering operational efficiency and impact.
• Develop and maintain a detailed project plan for remediation efforts, outlining tasks, timelines, responsibilities, and milestones.
• Monitor progress and regularly report to senior management and regulatory authorities on the status of remediation activities, including successes, challenges, and potential deviations from the plan.
• Collaborate with internal and external auditors to facilitate compliance audits and inspections, ensuring all documentation and evidence are readily available.
• Provide guidance, training, and support to staff members involved in compliance-related activities, fostering a culture of compliance excellence.
• Stay updated on changes to regulations, guidelines, and industry trends related to sterile manufacturing and compliance, and apply this knowledge to the ongoing improvement of compliance practices.
• Serve as a subject matter expert in compliance matters, providing insights and recommendations to senior leadership and cross-functional teams.
• Design and implement sustainable solutions to track product quality and site performance metrics.
• Author annual product quality reviews and site performance reports.

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Pharmacy, Chemistry, or other Life Science field.  
• 8+ years of experience in Quality Assurance and Compliance within a sterile manufacturing facility.

Preferred Qualifications:

• Masters Degree in Life Science.
• Experience collaborating with regulatory agencies and conducting audits or inspections.