Associate Director, Audit Readiness, Patient Support Services, OPIE
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
Associate Director, Audit Readiness, Patient Support Services, OPIE, located in Morristown, NJ and Cambridge, MA. Responsible for audit readiness across patient support programs, developing and maintaining audit readiness frameworks, managing CAPA and deviation processes, and ensuring compliance with internal policies and regulatory requirements. Serves as the primary point of contact for internal and external audits and leads cross-functional collaboration to resolve escalations and drive continuous improvement. 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 with 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 escalation point for deviations, exceptions, and process issues impacting patient programs; create and maintain escalation protocols and ensure timely resolution; collaborate with cross-functional teams 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. Qualifications
About You
Required: Bachelor’s degree; 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; project management experience with the ability to prioritize and execute multiple initiatives simultaneously. Preferred
Conflict resolution skills and ability to work collaboratively, 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; flexibility to adapt to changing priorities. Strong analytical skills and affinity for problem solving; exhibits integrity/trust; curiosity and willingness to challenge the status quo. Education
Bachelor’s degree required; advanced degree preferred.
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Associate Director, Audit Readiness, Patient Support Services, OPIE, located in Morristown, NJ and Cambridge, MA. Responsible for audit readiness across patient support programs, developing and maintaining audit readiness frameworks, managing CAPA and deviation processes, and ensuring compliance with internal policies and regulatory requirements. Serves as the primary point of contact for internal and external audits and leads cross-functional collaboration to resolve escalations and drive continuous improvement. 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 with 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 escalation point for deviations, exceptions, and process issues impacting patient programs; create and maintain escalation protocols and ensure timely resolution; collaborate with cross-functional teams 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. Qualifications
About You
Required: Bachelor’s degree; 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; project management experience with the ability to prioritize and execute multiple initiatives simultaneously. Preferred
Conflict resolution skills and ability to work collaboratively, 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; flexibility to adapt to changing priorities. Strong analytical skills and affinity for problem solving; exhibits integrity/trust; curiosity and willingness to challenge the status quo. Education
Bachelor’s degree required; advanced degree preferred.
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