Sanofi · 1 day ago
Associate Director, Audit Readiness, Patient Support Services, OPIE
Morristown, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. The Associate Director, Audit Readiness will lead audit preparedness activities across patient support programs, ensuring compliance with internal policies and regulatory requirements while managing corrective actions and driving continuous improvement initiatives.
Health CareLife SciencePharmaceuticalTherapeutics
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
Qualification
Required
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
Preferred
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 to respond effectively to the needs of the business is required
Flexible, able to adapt to changing business priorities
Strong analytical skills and affinity for problem solving
Exhibits integrity/trust
Curiosity and willingness to challenge the status quo
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-06
BioWorld Financial Watch
2026-01-06
2026-01-06
Company data provided by crunchbase