Quality Assurance Compliance Manager

QA Compliance Manager – Newtown, PA

The Compliance Manager is responsible for ensuring continuous compliance of investigational medicinal products with cGMPs and relevant regulations. This role will support the site self-inspection program, Health Authority inspections, perform general GMP readiness activities, and compliance initiatives, as necessary.

Key Duties & Responsibilities

• Leading and supporting self-inspections and inspection readiness activities of new and existing manufacturing facilities, laboratories and support areas.
• Lead and support internal audits and assessments to ensure compliance with relevant regulations.
• Ensure compliance with applicable regulations, policies, and procedures.
• Issue reports summarizing findings and tracks resulting CAPAs to satisfactory closure to maintain appropriate risk posture for the site. Notifies relevant management of unresolved issues or trends.
• Develop and maintain metrics and key performance indicators to measure trends and improve quality performance. Perform trending reviews of observations and commitments, compile trend reports and present outcomes to management and governing Quality Councils.
• Maintain an expert level of knowledge about GMP requirements and industry trends as described in applicable worldwide regulations. Will provide guidance and interpretation of GMP, regulatory, and compliance standards.
• Lead and support the preparation activities for GMP Compliance audits and Health Authority Inspections as needed.
• Track audit and inspection commitments to closure.
• Develop and harmonize procedures and processes that promote, facilitate and ensure compliance with domestic and international regulations and industry standards in support of the company’s objectives.
• Proactively identify, develop and implement opportunities for work / process improvement and efficiency.
• Promote a culture of quality and operational excellence. Proactively identify areas for improvement and work across multiple organizations to influence and implement solutions.
• Represents Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.
• Develop and maintain the supplier qualification program.
• Evaluate testing procedures to, meet the specifications and regulatory commitments.

Education & Experience

Prioritize and manage multiple priorities and projects independently.