Program Manager / Engagement Delivery Lead

USDM Life Sciences; United States; On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Health, vision & dental insurance

Life and disability insurance

401k plan

Paid time off

Rewards & recognition program

Job summary

USDM Life Sciences is seeking a Program Manager / Engagement Delivery Lead to act as the accountable delivery lead for a large-scale AI program modernizing a regulated data and content workflow into a validated, production-ready capability. This is a hands-on delivery role in a remote US setting with occasional travel (less than 10%) for workshops and steering meetings.

You will run a multi‑gate plan, coordinate cross‑functional teams, manage IQ/OQ/PQ and QA cadence, and ensure on-time invoicing

Qualifications

• 10+ years program leadership in pharma/biopharma tech delivery.
• GAMP 5 or CSA-validated system delivery experience.
• Delivery experience on cloud data or AI/ML programs.
• Milestone-based commercial management with NTE.
• Executive presence at VP/SVP level with strong materials.

Responsibilities

• Own delivery of a multi‑gate milestone plan from initiation to post‑launch hypercare.
• Run recurring joint steering with client co‑chairs and maintain risk register.
• Manage integrated critical path across IQ/OQ/PQ, QA, data conversion, and integration.
• Orchestrate a core delivery team with surge teams as one delivery unit.
• Drive scope governance, change orders, and contingency discipline.
• Own milestone‑aligned invoicing under time and materials not‑to‑exceed.
• Quality‑gate client artifacts with AI quality lead prior to submission.

Skills

Program leadership

GAMP 5 / CSA

AI/ML program delivery

Milestone management

Executive presence

Education

PMP or equivalent

Bachelor's degree

Master's degree preferred

SAFe / agile-at-scale

DAMA or cloud certs

Job description

Program Manager / Engagement Delivery Lead

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is hiring a Program Manager / Engagement Delivery Lead to serve as the accountable delivery lead for a large-scale, milestone-gated AI program modernizing a regulated data and content workflow into a validated, production-ready capability. This is a hands‑on delivery role, not a status‑reporting role. The successful candidate will run a multi‑gate delivery plan with documented exit criteria, weekly cross‑functional dependency reviews, and a team spanning a persistent core group plus elastic surge capacity, holding both a GxP validation sequence and an agentic AI build plan in one integrated schedule. This role is remote within the US, with occasional travel (less than 10%) for on‑site workshops and steering meetings.

Primary Responsibilities

• Own delivery of a multi‑gate milestone plan, from initiation through environment qualification, validation sign‑off, data layer proof, system operational readiness, and a post‑launch hypercare period.
• Run recurring joint steering with client co‑chairs, maintaining a live assumption and risk register with formal re‑baselining at key checkpoints.
• Manage the integrated critical path across environment approvals, IQ/OQ/PQ, QA approvals, data conversion, and system integration, with named owners and defined slip escalation thresholds.
• Orchestrate a core delivery team alongside multiple surge teams as one delivery unit, governing team stand up, closure, and knowledge capture.
• Drive scope governance, including early‑stage scope elections, change orders for expanded scope, and contingency discipline.
• Own milestone‑aligned invoicing against a time and materials not‑to‑exceed structure.
• Quality‑gate all client‑facing artifacts with the internal AI quality lead before submission.

Required Qualifications

• 10+ years program leadership in pharmaceutical or biopharmaceutical technology delivery, including 3+ years leading multi‑million dollar consulting engagements end to end.
• Direct experience delivering a GAMP 5 or CSA‑validated system into production at a major pharmaceutical company, including IQ/OQ/PQ sequencing, QA approval cadences, and Part 11 considerations.
• Delivery experience on cloud data or AI/ML programs; comfortable governing agentic AI scope without personally engineering it.
• Milestone or gate‑based commercial management, including T&M with NTE, contingency governance, and driver‑based change control.
• Executive presence at VP/SVP level, with excellent written status and steering materials.

Education & Certifications

PMP or equivalent demonstrable track record required; SAFe/agile‑at‑scale and DAMA or cloud certifications a plus. Bachelor’s degree required (Engineering, Computer Science, Life Sciences, or a related field); Master’s degree preferred.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all‑inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
• Occasional travel (less than 10%) to client sites for on‑site workshops and steering meetings.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Annual Salary Range (W2): USD 180,000 - 230,000

The compensation range represents the anticipated low and high end of USDM's compensation range for this position. Actual compensation will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full‑time employees are eligible for health, vision, and dental insurance, life insurance, short and long‑term disability, hospital indemnity, accident, and critical care coverage.

Both full and part‑time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part‑time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.