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Job Description

A fast-growing 503B compounding pharma company, is seeking a hands-on IT Project Manager to lead critical technology

initiatives in a regulated startup environment. This hybrid (mostly remote) role is a 6-month contract-to-hire opportunity, meaning a successful contractor can transition to a full-time role. The IT Project Manager will drive the rollout of several enterprise systems (MasterControl QMS, Oracle NetSuite ERP,

DataNinja MES, Blue Mountain, Legisym) while owning key IT compliance processes. We need a candidate with a strong execution mindset – someone who can strategize at a high level and also dive into tactical details. You will coordinate across departments (IT, Quality, Manufacturing, Operations, etc.) to ensure projects meet both business objectives and strict FDA regulatory requirements (e.g. 21 CFR Part 11). If you have life sciences IT experience (pharmaceutical industry required, 503B highly preferred) and excel at driving projects to completion in a GxP-compliant environment, we want to hear from

you.

Essential Skills

+ Education & Certification: Bachelor’s degree in Information Systems, Computer Science, Engineering or a related field. PMP certification or similar project management training is a plus but not required.

+ Industry Experience: 5+ years of IT project management experience, with 3+ years in the pharmaceutical or life sciences industry. Direct experience in an FDA-regulated manufacturing environment is required (503B compounding pharmacy experience highly preferred). You should be well-versed in GxP regulations and the challenges of a startup or high-growth company where processes may still be maturing.

+ Hands-On Project Management: A “doer” mindset with the ability to not only track tasks but also actively produce deliverables. Capable of creating detailed project timelines, drafting project documents/templates, entering and analyzing data (e.g. for configuration or migration), and generally rolling up your sleeves to drive project tasks to completion.

+ Startup Adaptability: Prior exposure to a startup or high-growth company where you helped build processes, teams, or systems from scratch. Comfort with wearing multiple hats and adapting to evolving needs will help you excel in this role.

+ Enterprise Systems Implementation: Proven track record of implementing and delivering enterprise software systems in a regulated context. Experience with any of the specific systems is a strong plus (e.g., electronic Quality Management Systems like MasterControl, ERP systems like NetSuite, Manufacturing Execution Systems like DataNinja, or lab/maintenance systems like Blue Mountain). Ability to coordinate data migration, configuration, testing, and user training for such systems is essential.

+ Regulatory & Compliance Knowledge: Solid understanding of 21 CFR Part 11 requirements for electronic records/signatures and familiarity with Good Practice (GxP) guidelines (e.g., GMP, GCP as applicable). Hands-on experience with Computer System Validation (CSV) practices in alignment with GAMP5 or similar frameworks. Knowledge of IT change control processes, data integrity principles (ALCOA+), and overall IT quality management is required. Attention to detail in documentation and adherence to procedures must be a strong suit.

+ Project Management Skills: Exceptional project management and organizational skills. Able to create and manage detailed project plans, handle multiple concurrent projects or workstreams, and adapt to changing priorities. Risk management capabilities – identifying project risks (schedule, compliance, etc.) and mitigating them proactively. Experience leading cross-functional teams, running steering committee meetings, and providing clear project reporting to stakeholders.

+ Vendor and Stakeholder Management: Demonstrated ability to manage third-party vendors and consultants. Experience negotiating and overseeing vendor contracts, SLAs, and deliverables. Comfortable holding vendors accountable to timelines and quality standards. Strong stakeholder management skills – able to work closely with Quality Assurance, Operations, Supply Chain, and Finance teams to ensure IT solutions meet their needs. Excellent communication skills (written and verbal) to convey technical information to non-technical stakeholders and to document project and compliance materials clearly.

+ Technical Aptitude: Broad understanding of IT infrastructure and applications. While not a hands-on engineer, you should understand key concepts in networking, cloud/SaaS, databases, and cybersecurity as they pertain to system implementation and compliance (for example, understanding user access controls, data backup routines, interface integrations, etc.). Ability to troubleshoot issues at a high level and work with technical specialists to resolve them. Proficiency in typical tools such as project management software, Office 365, and possibly validation documentation systems.

+ Execution & Adaptability: A bias for action and ability to thrive in a fast-paced startup environment. You are detail-oriented yet can make swift progress by applying pragmatic solutions. Comfortable working independently and as part of a small team, wearing multiple hats – one day you might be drafting a project charter, the next day updating an SOP or labeling equipment for inventory. Adaptability and problem-solving are key, as this role will continually evolve with the company’s growth.

+ Additional Skills & Qualifications

+ 503B or GMP Manufacturing Experience: Direct experience in a 503B compounding pharmacy or similar GMP manufacturing operation. Understanding the unique regulatory and operational nuances of 503B facilities will allow you to hit the ground running.

+ Familiarity with Specific Systems: Prior hands-on involvement with systems like MasterControl, NetSuite, DataNinja MES, Blue Mountain RAM, or Legisym’s CSOS platform. Experience participating in their implementation or validation will be an advantage.

+ Quality Systems & Audits: Experience interacting with Quality Management Systems beyond IT’s scope – for instance, participating in regulatory inspections or FDA audits, supporting validation of lab instruments or facilities systems, etc. Experience in authoring or revising SOPs and conducting training sessions for compliance topics.

+ Certifications: In addition to PMP, any relevant certifications such as ITIL (for IT service management), Certified Scrum Master (if agile methodology is used), or advanced CSV training/certification. These demonstrate a commitment to best practices in IT operations and project delivery.

+ Leadership in Small Teams: Experience taking leadership in a small, growing company or team where you built processes from the ground up. Ability to mentor junior IT staff or influence without direct authority to champion compliance and project discipline across the organization.

+ Strong Documentation Skills: Recognized for producing high-quality documentation (project plans, validation protocols, reports, SOPs). In a regulated environment, documentation is as important as execution, so an eye for crafting clear, audit-ready documents is a plus.

Work Environment

The work environment is within an FDA-registered 503B outsourcing facility specializing in sterile compounded medications. The company operates under strict cGMP and regulatory oversight. The schedule is Monday to Friday, 9 am to 5 pm, within a clean room environment. This is a startup environment, and you will be the first hire in this role.

Job Type & Location

This is a Permanent position based out of Colonie, NY.

Pay and Benefits

The pay range for this position is $100000.00 - $150000.00/yr.

*Must have 5 employees to enroll in benefits; coming soon!Can be competitive with other benefits (PTO/Holidays/etc)

Workplace Type

This is a fully onsite position in Colonie,NY.

Application Deadline

This position is anticipated to close on Nov 26, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.