Associate Director, Audit Readiness, Patient Support Services, OPIE

Role Summary

Associate Director, Audit Readiness, Patient Support Services, OPIE, located in Morristown, NJ and Cambridge, MA. You will serve as the primary lead for audit preparedness across all patient support programs, develop audit readiness frameworks, manage CAPA and deviation processes, and ensure compliance with internal policies, SOPs, and regulatory requirements. You will act as the point of contact for audits, partner with cross-functional teams, and drive continuous improvement in quality and compliance.

Responsibilities

• Serve as the primary point of contact for internal and external audits related to patient support programs.
• Develop and maintain audit readiness plans, including documentation requirements, timelines, and stakeholder responsibilities.
• Ensure timely closure of audit findings and manage corrective and preventive actions (CAPAs) within appropriate systems.
• Partner with Quality and Compliance teams to ensure alignment with global standards and regulatory requirements.
• Lead the development, review, and maintenance of SOPs, Work Instructions (WINs), and training materials for internal teams and vendors.
• Provide guidance on processes related to adverse event (AE) and product technical complaint (PTC) reporting, co-pay programs, and free drug workflows.
• Standardize quality review requirements across therapeutic areas to improve efficiency and reduce documentation burden.
• Act as the escalation point for deviations, exceptions, and process issues impacting patient programs.
• Create and maintain escalation protocols and ensure timely resolution of cases.
• Collaborate with cross-functional teams (Medical, Regulatory, Pharmacovigilance) to implement planned deviation processes for product launches.
• Establish project timelines and governance for new product launches to ensure readiness and compliance.
• Drive continuous improvement initiatives to enhance audit preparedness and operational efficiency.
• Partner with internal and external stakeholders to implement best practices and mitigate compliance risks.

Qualifications

• 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.
• Preferred: Advanced degree.

Education

• Bachelor’s degree required; advanced degree preferred.