Introduction

At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations.

Slipstream’s industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth.

Job Summary

Contract / Program Manager, Pharma IT Infrastructure and Operations is a pivotal role responsible for executing programs/projects across the entire lifecycle of commercial, clinical and regulatory IT initiatives, from supporting market launch and post-launch support. This person ensures projects are delivered on time, within budget, and meet high-quality standards while aligning with strategic business objectives. You will be responsible for overseeing a portfolio of projects that design, implement, and maintain an organization's IT infrastructure and systems, including software, operations, and data management.

Responsibilities

Manage cross-functional IT projects, spearheading process streamlining, training, audits, regulatory readiness, and KPI/metrics tracking to achieve on-time delivery and business objectives.
Analyze and convey risk and compliance adherence principles and practices to institute their adoption and acceptance.
Served as program manager and implemented corrective action plans ensuring responsible parties were assigned, documented, and committed to actions within realistic targets; conducted deep-dive SWOT analysis in categories/ groups of deviations and CAPAs from different sources to coordinate major action plans with IT senior management
Support the design implementation and management of enterprise-wide IT systems networks and cloud solutions.
Partner with teams to optimize IT service management processes such as continuous improvement and change management.
Work closely with Sr Director of Infrastructure and Operations and security teams to establish best practices and scalable solutions.
Ensure solutions and operations comply with GxP, FDA 21 CFR part 11, HIPAA, and ISO 13485 requirements.
Work closely with QA regulatory and compliance teams to align its practices with industry regulations.
Support vendor qualifications and audits for IT systems used in GxP environments.
Draft and maintain comprehensive documentation and SOPs for IT processes to meet adoption and audit requirements.
Contribute to the culture of continuous improvement innovation and collaboration.

Requirements

Bachelor’s degree (or experience) in Computer Science, Information Technology, or related field.
7 plus years of IT experience with at least 3 to 5 years in leadership roles overseeing IT projects and programs.
5 plus years of program management experience with at least 3-5 years of commercial pharma experience.
Strong experience in regulated environments (Pharmaceutical, Biotech, Clinical or Medical Device industries).
Strong understanding of GXP, FDA 21 CFR part 11, HIPAA, GDPR, and ISO 27001 compliance.
Experience in data warehousing, reporting and analytical project implementation in commercial and clinical areas.
Proven track record implementing enterprise IT commercial, clinical, and regulatory solutions.
Experience coordinating programs across multi-site and global IT operations in pharmaceutical commercial, regulatory, or clinical settings.
Demonstrated ability to lead digital or technology transformation initiatives including cloud migrations, automation, and IT operations.
Strong vendor management skills include contract negotiations with cloud providers, IT service partners, and managed services organizations.
Strategic thinking - ability to align IT infrastructure and operations with business and regulatory needs.
Collaboration and communication - ability to work across R&D, clinical, manufacturing, regulatory, and commercial teams.
Problem solving - strong analytical skills for troubleshooting complex IT and operational challenges.

Nice-to-haves

Relevant certifications (preferred but not required):
- PMP Certification
- Scrum Master
- BRM Certification
- Smartsheet Certification
Experience with JIRA Work Schedule

Work Schedule

Monday to Friday, 8:00 AM to 5:00 PM EST.
Must be flexible to accommodate departmental needs and client/staff time zones.
At times, overtime may be needed to accomplish deliverables which could include evenings or weekend hours.
For all remote meetings, there is an expectation of being on-camera for all meetings with appropriate business attire and standard Slipstream virtual background.

Work Location

Place of employment is expected to be 60-70% on-site at Hampton, NJ location and 30-40% remote.
For all remote meetings, all employees are required to be on-camera with appropriate business casual attire and background.

Physical Requirements

This position requires the ability to remain in a stationary position, often standing or sitting for prolonged periods.
The ability to move about to accomplish tasks. Adjusting or moving objects up to 20 pounds in all directions.
Communicating verbally and written word with others to exchange information.
Exposure to a standard office environment with average room temperatures with no adverse environmental conditions expected.

Hourly Rate

$80/hr.-$85/hr.

Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.

Slipstream IT

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Program Manager, Pharma IT Infrastructure and Operations - Hampton, NJ