Associate Director, Audit Readiness, Patient Support Services, OPIE

Job Title: Associate Director, Audit Readiness, Patient Support Services, OPIE
Location: Morristown, NJ Cambridge, MA

About the Job

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you’ll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.

The Associate Director, Audit Readiness will report to the Sr. Director, Patient Support Services Quality and Compliance, OPIE and serve as the primary lead for audit preparedness activities across all patient support programs. This role is responsible for developing and maintaining audit readiness frameworks, managing CAPA and deviation processes, and ensuring compliance with internal policies, SOPs, and regulatory requirements. The Associate Director will act as the point of contact for internal and external audits, partner with cross-functional teams to resolve escalations, and drive continuous improvement initiatives to strengthen quality and compliance. This position requires strong operational expertise, strategic thinking, and the ability to manage complex projects in a matrixed environment.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main 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 corrective and preventive actions (CAPAs) within appropriate systems.

• 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, 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.

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 of cases.

• 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.

• 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.

About You

Qualifications

• Bachelor’s degree required; advanced degree preferred.

• Minimum of 5 years of experience in patient support services, healthcare program management, or a 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 ability to prioritize and execute multiple initiatives simultaneously

Preferences:

• Conflict resolution skills and ability to work collaboratively, along with strong organizational and operational skills.

• Ability to multitask and prioritize delivering results within timelines.

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