Associate Director - Program Management – Quality & Compliance Programs

Cabaletta Bio; Philadelphia (Philadelphia County); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive benefits

Paid time off

Stock option plans

Job summary

Cabaletta Bio in Philadelphia seeks an Associate Director – Program Management, Quality & Compliance. This hybrid role focuses on the strategic planning and execution of Quality activities in product development. Candidates should have a strong background in the pharmaceutical industry, with 8+ years of relevant experience and proficiency in project management.

The ideal applicant will manage cross-functional projects, prepare reporting for senior management, and support Regulatory Affairs submissions. A competitive benefits package is included.

Qualifications

• 8+ years of experience in technical operations and project/program management.
• Experience in pharmaceutical or biotechnology industries is required.
• Certification in project management (e.g., PMP, CAPM) is preferred.

Responsibilities

• Manage projects and programs for Quality activities in product development.
• Initiate and maintain cross-functional collaboration to drive project progress.
• Prepare and present project reports to senior management.

Skills

Project management

Risk assessment

Communication

Collaboration

SmartSheet proficiency

Detail orientation

Customer service

Education

Advanced degree in Life Sciences

Tools

SmartSheet

MS Office

Job description

Associate Director – Program Management, Quality & Compliance Programs (Hybrid)

Reporting into the PMO, the Associate Director – Program Management, Quality & Compliance will support the strategic planning, coordination, and execution of all Quality activities across all stages of product development and commercialization. The role operates within the Quality & Compliance department with close collaboration with the enterprise PMO team and cross‑functional teams beyond Quality & Compliance.

Responsibilities

• Partner with various Program Leads of Quality programs to effectively manage the projects and programs.
• Schedule and lead team meetings, including developing agendas, publishing meeting minutes and decision logs, and tracking action items to completion.
• Initiate and maintain cross‑functional collaboration and communication to drive project progress and team alignment.
• Prepare and present slide decks, project reporting and updates to senior management and key stakeholders to inform and drive decision making.
• Work with Quality & Compliance Leadership Team to provide scenario planning and project reporting for all Quality & Compliance project management activities, aligning them with company goals and regulatory requirements; develop and maintain charters, dashboards, trackers and schedules.
• Perform project planning and due diligence including development of scope, timeline, budget, and resource plan to the Quality‑focused and Enterprise project portfolio.
• Support ongoing program management initiatives for the enterprise PMO by utilizing and/or creating project management tools and templates across the company to contribute to continuous improvement.
• Work extensively with the lead Asset PM to support the cross‑functional Product Development Team Program and the CABA‑201 clinical program.
• Work closely with Clinical Teams, Regulatory Affairs, Technical Development and Supply Chain to support the preparation and submission of regulatory filings, including INDs and BLAs.
• Identify potential project risks, maintain risk registers, conduct risk assessments and develop mitigation strategies proactively.
• Act as a strategic partner with Finance and Legal teams to resolve issues quickly and facilitate on‑time, on‑budget delivery of project milestones.
• Work across time zones as necessary.
• Travel 10–15% may be required.
• Other duties as assigned.

SmartSheet Management

• Utilize SmartSheet for project planning, tracking, and reporting both within a single project and across multiple projects/programs, creating one unified portfolio summary/report.
• Create, maintain, and publish SmartSheet dashboards and reports for project status updates.
• Work with the PMO team to ensure all department timelines and risk trackers integrate within the overall corporate portfolio and integrated roadmaps.
• As SmartSheet Super User, train and support team members on SmartSheet use, management, and reporting as well as other functionalities.

Qualifications

• Experience in pharmaceutical or biotechnology industries is required.
• Advanced degree in Life Sciences is preferred.
• 8+ years of experience in technical operations, specific project/program management experience required; experience in C&GT, CAR‑T or similar industry preferred.
• Direct experience supporting regulatory Health Authority Inspections in a GxP‑regulated environment is required.
• Certification in project management (e.g., PMP, CAPM) is preferred.
• Experience with both early‑ and late‑stage clinical programs is an advantage.
• Proficiency in MS Office (Outlook, PowerPoint, Excel, Word) and familiarity with project management tools is required.
• Strong understanding of PM best practices, operating in a PMO and scaling processes in a growing corporate environment is required.
• Extensive experience in utilization of Smartsheet including creation, maintenance, and reporting of timelines, Gantt charts, dashboards, and reports.
• Excellent external facing representation and experience in managing vendor relationships and contracts.
• Strong verbal and written communication skills.
• Outstanding attention to detail with the ability to manage multiple tasks and priorities.
• Ability to work independently and collaboratively with cross‑functional teams.
• Thrives in a dynamic, fast‑paced, timeline‑based environment.
• Strong customer service focus as part of Cabaletta’s PM culture.

Benefits

• Competitive benefits, paid time off, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.