Program Quality Associate Director, Assurance

Job Description

General Summary:

Vertex Patient Support (VPS) is seeking an experienced and highly motivated Associate Director Assurance (AD Assurance) to serve as a key leader within the US Patient Support Center of Excellence (COE) Program Quality team. Reporting to the Director of Program Quality the AD provides operational leadership for the execution of the assurance program across Cystic Fibrosis Kidney and Hematology Patient Support Programs (PSPs) supporting both GxP and non-GxP functions.

The Associate Director will provide oversight for the execution of quality assurance activities including internal audits and continuous monitoring corrective and preventive action (CAPA) management and quality collaboration with the Director the role will partner closely with Patient Support Teams (PST) Compliance Legal Privacy Internal Audit and other cross-functional stakeholders to ensure compliance with regulatory standards and other operating requirements.

As a people leader the Associate Director will develop and empower a high-performing team while driving proactive quality initiatives that strengthen the patient and provider experience mitigate risk and improve operational performance.

Key Duties and Responsibilities:

Assurance Audit Monitoring and Compliance Oversight

• Oversee the execution of all internal PSP audit and monitoring activities to evaluate regulatory compliance customer experience and adherence to program requirements and standard operating procedures. Scope includes but not limited to PSP communication monitoring compliance events deviations and pharmacovigilance activities.
• Analyze monitoring and audit results to identify emerging risks systemic issues and opportunities for process improvement as well as provide visibility into performance and risk areas across PSPs
• Partner closely with the Director and PSP stakeholders to ensure appropriate steps are taken to address audit findings/observations of nonconformance
• Ensure effective management tracking and timely closure of CAPAs
• Support organizational readiness for internal external and regulatory inspections or assessments
• Collaborate with the Director of Program Quality to maintain and advance the PSP Assurance Strategy work instructions quality standards and monitoring methodologies.
• Other responsibilities as assigned by the Director.

Cross-Functional Partnership

• Facilitate governance discussions related to audit findings compliance events monitoring trends and remediation strategies.
• Identify opportunities for operational efficiencies and continuous improvement and partner with colleagues in other disease areas to share learnings / best practices
• Manage current and future cross-functional assurance projects to improve processes that support the multilayered PST (e.g. guidance regarding community events creating a template of shared resources between the PST and the field)
• With guidance from the Director partner closely with OBIE Legal Privacy and Internal Audit teams to ensure effective management of quality and compliance risks.

People Leadership

• Lead coach and develop a team of quality professionals responsible for executing assurance activities across multiple patient support programs.
• Establish clear performance expectations and foster a collaborative inclusive and results-oriented team environment.
• Promote innovation critical thinking and continuous improvement among team members.

Required Knowledge and Skills:

• Demonstrated expertise in developing and executing risk-based assurance programs within highly regulated environments.
• In-depth knowledge and demonstrated application of key quality management principles including:
  • Root cause analysis tools and methodologies
  • CAPA development and management
  • Audit and inspection readiness including development of auditing and monitoring tools and procedures
• Ability to independently drive results with urgency and operate effectively in a fast-paced dynamic environment
• Proven ability to evaluate quality matters and make complex decisions leveraging technical experience advanced judgement and the analysis/synthesis of a variety of information
• Strong analytical strategic thinking and problem-solving skills with the ability to assess risk identify gaps and implement practical compliant solutions.
• Excellent written verbal presentation and facilitation skills including the ability to tailor communications to different audiences
• Advanced project management and execution skills including the ability to lead complex cross-functional initiatives; develop and manage project plans and ensure timely completion of key deliverables.
• Understands how systems and databases are structured and can consolidate multiple data sources and synthesize large datasets into key findings and recommendations
• Intermediate proficiency in data analysis and visualization tools such as Microsoft Excel Power BI Tableau
• Demonstrated ability to influence and build strong partnerships across matrixed organizations with diverse stakeholder groups.
• Proven people leadership experience with a track record of coaching developing and retaining high-performing teams.

Education and Experience:

• Minimum: A bachelors degree with 5 years pharmaceutical/biotech/healthcare industry experience AND 5 years hospital/biopharmaceutical patient support quality management experience with progressive responsibility in quality compliance audit monitoring or patient support program operations
• Experience in pharmaceutical GxP auditing monitoring and quality management systems required
• Minimum of 3 years of direct people leadership experience preferred.
• Exposure to Salesforce platforms including Service Cloud Health Cloud and/or Life Sciences Cloud.
• Strong executive communication and presentation skills including the ability to develop compelling presentations and quality reporting for senior stakeholders.

Preferred Qualifications:

• Masters degree in health administration health services research quality and patient safety or public health strongly preferred.
• Professional certifications such as ASQ CQA CPHQ or similar quality/compliance credentials are a plus.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at