21 CFR part 11 Project Manager / Program Manager

Atika Technologies

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Carlsbad, CA, us on site Until 8/21/2026 First posted March 21, 2025 Last posted March 21, 2025
Job description

Atika is a professionally run staffing services provider assisting clients all across U.S. and Canada. Working with corporations and state departments over the years, we have developed deep insights and expertise in offering staff augmentation services that are absolutely top notch.

Our methodology and approach ensure that we work closely with the clients, availing them of a world class service. The foundations of our service are quality in everything we do and treating our clients as an extension of our organization. We offer flexible staffing models that suit your needs, budgets and time lines.



PM with 21 CFR 11 (Electronic Records; Electronic Signatures) experience


Location: Carlsbad, CA

Deliverables:

• Oversee all aspects of project scope, schedule, resource, risks and overall management to ensure and drive successful delivery.
• Ensure the software development and project management deliverables and milestones in project plans are achieved within cost, schedule, scope, and quality.
• Assure that the project teams are managing the system development process including systems analysis, technical design, coding, testing, turnover to production, user acceptance criteria.
• Conduct proper and timely communications, change management, and training per project stakeholders and needs.
• Provide overall capital and operating expense project budget responsibility for multiple projects.
• Manage critical supplier and internal customer relationships.
• Maintain extensive knowledge and expertise in project management disciplines, as well as multiple business processes and/or technical areas.
• Experience supporting different cross-functional applications projects
• Any experience in CRM, ERP, Validation applications, Financial area, etc. is desirable.
• Leverage industry best practices to plan, manage, monitor and report on all projects

Skills and Credentials:

• Bachelor's degree in computer science, computer engineering, electrical engineering, systems analysis or a related field of study, or equivalent experience, and/or Master’s degree a plus6+ years of hands-on SDLC IT project/program management
• Experience working in an IT PMO is a plus
• Proven ability to lead groups, manage project deliverables, and maintain client relationships
• Experience in managing budgets, project plans, resource allocations, and priorities.
• MS Suite, Visio, expertise with Excel, MS Project
• Demonstrated skills with portfolio and project management tools such as HP PPM, is a plus.
• Demonstrated expertise with various industry PM methodologies including AGILE, SCRUM, RUP, Waterfall, PMI PMBok, PMP Certified
• Exposure to multiple, diverse technologies across a large, global environment.
• Exceptional interpersonal skills, including teamwork, facilitation and negotiation.
• Strong leadership skills.
• Excellent analytical and technical skills allowing for quick decision making and direction setting.
• Excellent written and verbal communication skills. Multiple languages a plus.
• Excellent planning and organizational skills.
• Ability to balance the long-term ("big picture") and short-term implications of individual decisions.
• Ability to apply multiple solutions to business problems.

All your information will be kept confidential according to EEO guidelines.

About this role

Summary

Manage IT projects ensuring compliance with 21 CFR 11, overseeing scope, schedule, and resources.

Job title

21 CFR part 11 Project Manager / Program Manager

Experience level

6+ years

Industry

staffing services

Location requirements

Carlsbad, CA, on-site, no remote work specified

Salary

Not specified

Management role

Yes

Skills & keywords

Required skills

project management21 CFR 11SDLCPMPMS Project

Preferred skills

AgileScrumRUPWaterfallHP PPM

Specializations

21 CFR 11project managementsoftware developmentvalidationcompliance
Locations

Structured locations inferred from the posting.

Carlsbad, CA, USA

On-site City