Job Description
Location: Boston, M A – Hybrid
**This role will require some presence on site at our client in the Boston, MA area**
**This role is not eligible for relocation assistance**
Role Overview
We are seeking a highly driven AI Technical Program Manager (AI TPM) to lead the end-to-end delivery of AI-powered digital initiatives across Quality and CMC operations. This role will drive cross-functional execution of AI use cases, ensuring alignment between Digital, Quality, Regulatory, Manufacturing, and Data Science teams.
The AI TPM will be responsible for translating business needs into scalable, compliant AI solutions while managing technical dependencies, governance, risk, and value realization in a regulated (GxP) environment.
Key Responsibilities
Program Leadership & Execution
- Lead complex AI programs from ideation through deployment and scaling.
- Develop and manage program roadmaps, milestones, risks, and KPIs.
- Coordinate cross-functional teams (Data Science, IT, Quality, Manufacturing, Vendors).
- Ensure alignment with enterprise digital and AI strategy.
AI Use Case Delivery
- Partner with business stakeholders to define high-value AI use cases (e.g., deviations, CAPA prediction, batch analytics, document intelligence).
- Oversee model development lifecycle (data readiness, training, validation, deployment).
- Ensure AI solutions are scalable, secure, and production-ready.
Governance & Compliance (GxP Focus)
- Embed AI governance frameworks (model validation, explainability, bias monitoring).
- Ensure compliance with regulatory requirements (FDA, EMA, GAMP5, CSA).
- Drive documentation for audit readiness and inspection preparedness.
- Manage data integrity standards (ALCOA+).
Technical Oversight
- Understand system architecture (LIMS, MES, SAP, Veeva, data platforms).
- Manage integration dependencies across enterprise systems.
- Partner with cloud, cybersecurity, and infrastructure teams.
- Oversee vendor technical performance.
Risk & Change Management
- Identify technical and regulatory risks early and drive mitigation.
- Manage change adoption within Quality and CMC functions.
- Develop communication plans for executive and operational stakeholders.
Value Realization
- Define measurable KPIs (cycle time reduction, deviation reduction, automation rate).
- Track ROI and business impact of AI initiatives.
- Ensure sustainable scaling of successful pilots.
Required Qualifications
- 8+ years in Technical Program Management, Digital Transformation, or Engineering Program Delivery.
- 3+ years leading AI/ML or advanced analytics initiatives.
- Experience in regulated industries (Pharma, Biotech, Medical Devices).
- Strong understanding of AI/ML lifecycle and data governance.
- Experience working with enterprise platforms (LIMS, MES, SAP, Veeva, etc.).
- Strong stakeholder management and executive communication skills.
CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies.
We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.
We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.
If you share these sentiments and are prepared for the atypical, then Zifo is your calling!
Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
