Associate Director, Audit Readiness, Patient Support Services, OPIE

Role Summary

Associate Director, Audit Readiness, Patient Support Services, OPIE. Location: Morristown, NJ; Cambridge, MA. The role leads audit readiness for patient support programs, develops frameworks, manages CAPA and deviation processes, and ensures compliance with internal policies, SOPs, and regulatory requirements. Acts as the point of contact for internal and external audits and partners with cross-functional teams to resolve escalations and drive continuous improvement.

Responsibilities

• Audit Readiness & Compliance: Serve as the primary point of contact for internal and external audits related to patient support programs; develop and maintain audit readiness plans; ensure timely closure of audit findings and manage CAPAs; partner with Quality and Compliance teams to align with global standards and regulatory requirements.
• Process Governance & SOP Management: Lead development, review, and maintenance of SOPs, Work Instructions (WINs), and training materials for internal teams and vendors; guidance on AE/PTC reporting, co-pay programs, and free drug workflows; standardize quality review requirements across therapeutic areas.
• Deviation & Escalation Management: Act as escalation point for deviations and process issues; create and maintain escalation protocols and ensure timely resolution; collaborate with cross-functional teams to implement deviation processes for product launches.
• Operational Excellence & Project Management: Establish project timelines and governance for new product launches; drive continuous improvement to enhance audit preparedness and efficiency; partner with stakeholders to implement best practices and mitigate compliance risks.

Qualifications

• Required: Bachelor's degree; Preferred: Advanced degree.
• Required: Minimum of 5 years of experience in patient support services, healthcare program management, or a related field.
• Required: Strong analytical and problem-solving abilities.
• Required: Strong verbal and written communications and interpersonal skills with the ability to influence, collaborate and deliver solutions in a highly complex, matrixed environment.
• Required: Ability to work independently and as part of a team.
• Required: Proven ability to manage audits, CAPAs, and SOP governance in a complex, matrixed environment.
• Required: Excellent communication, leadership, and stakeholder management skills.
• Required: Project management experience with ability to prioritize and execute multiple initiatives simultaneously.

Skills

• Audit readiness planning and execution
• CAPA and deviation management
• SOP governance and training material development
• Cross-functional collaboration and stakeholder management
• Regulatory compliance and quality systems
• Process improvement and operational excellence
• Project management and strategic thinking