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 serves as the primary lead for audit preparedness activities across all 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. This position requires strong operational expertise, strategic thinking, and the ability to manage complex projects 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; develop and maintain audit readiness plans including documentation requirements, timelines, and stakeholder responsibilities; ensure timely closure of audit findings and manage CAPAs within appropriate systems; 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, WINs, and training materials for internal teams and vendors; provide guidance on AE and PTC reporting, co-pay programs, and free drug workflows; 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; create and maintain escalation protocols and ensure timely resolution; collaborate with Medical, Regulatory, and 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; drive continuous improvement to enhance audit preparedness and operational efficiency; partner with internal and external stakeholders to implement best practices and mitigate compliance risks.

Qualifications

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

Preferred Qualifications

• Conflict resolution skills and ability to work collaboratively, along with strong organizational and operational skills.
• Ability to multitask and prioritize delivering results within timelines.
• Strong sense of urgency.
• Identify opportunities to enhance team effectiveness, increase process efficiencies, and respond effectively to business needs.
• Flexible, able to adapt to changing business priorities.
• Strong analytical skills and affinity for problem solving.
• Integrity/trust; curiosity and willingness to challenge the status quo.

Skills

• Audit management
• Regulatory compliance
• Quality and CAPA processes
• SOP governance
• Process improvement
• Project management
• Cross-functional collaboration
• Communication and stakeholder management

Education

• Bachelor’s degree required; advanced degree preferred.