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 preparedness across patient support programs, developing audit readiness frameworks, managing CAPA and deviation processes, and ensuring compliance with internal policies, SOPs, and regulatory requirements. Acts as the point of contact for internal and external audits, partners with cross-functional teams to resolve escalations, and drives continuous improvement to strengthen quality and compliance in a matrixed environment.

Responsibilities

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

Qualifications

• Education: Bachelor’s degree required; advanced degree preferred.
• 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: Conflict resolution skills and ability to work collaboratively, along with strong organizational and operational skills.
• Preferred: Ability to multitask and prioritize delivering results within timelines.
• Preferred: Strong sense of urgency.
• Preferred: Identify opportunities to enhance team effectiveness, increase process efficiencies, and respond effectively to business needs.
• Preferred: Flexible, able to adapt to changing business priorities.
• Preferred: Strong analytical skills and affinity for problem solving.
• Preferred: Exhibits integrity/trust.
• Preferred: Curiosity and willingness to challenge the status quo.