Demonstrated experience running medium to large-scale projects
Strong knowledge of project management processes and best practices
Excellent analytical and communication skills
Familiarity with GMP Quality Control operations and laboratory systems
Requirements:
Coordinate project team activities and support resource planning
Facilitate governance forums and prepare executive-level status updates
Drive alignment across QC, Quality, IT, Validation, Regulatory, and site stakeholders
Manage integrated project plans and track milestones, risks, and action items
Job description
Duration: 12 months contract
Job Description:
Seeking an experienced Senior Project Manager to support global Quality Control technology implementation initiatives in a regulated biotech/pharma environment.
This role will manage high-level, complex, cross-functional projects within defined scope, quality, timeline, and cost expectations to deliver agreed business and operational requirements.
The Project Manager will coordinate global and site-level workstreams, maintain integrated project plans, manage risks, issues, dependencies, decisions, and action items, and ensure project objectives and requirements are clearly documented.
Responsibilities:
Responsibilities include coordinating project team activities, supporting resource planning, facilitating governance forums, preparing executive-level status updates, and driving alignment across QC, Quality, IT, Validation, Regulatory, and site stakeholders.
The role may support multiple phases of the implementation lifecycle, including requirements gathering, business process analysis, design, testing, implementation planning, change management, training readiness, procedural updates, qualification/validation readiness, regulatory readiness, and operational handoff.
Qualifications:
The ideal candidate has demonstrated experience running medium to large-scale projects, strong knowledge of project management processes and best practices, excellent analytical and communication skills, and the ability to work effectively across cross-functional teams and management levels.
Experience with business process development, change management, collaboration tools, and project documentation tools such as MS Project, Excel, PowerPoint, Word, Smartsheet, or equivalent is strongly preferred.
Familiarity with GMP Quality Control operations, laboratory systems, data integrity, SOPs, change controls, and qualification/validation activities is highly desirable.
Day-to-Day Responsibilities:
Manage the integrated project plan for QC technology implementation activities across global and site-level workstreams.
Coordinate with site project managers to track milestones, dependencies, risks, issues, decisions, and action items.
Facilitate routine project meetings, governance forums, and cross-functional working sessions.
Partner with QC SMEs, Quality, IT, Validation, Regulatory, and site teams to drive alignment on implementation activities.
Track progress against key deliverables, including procedural updates, change controls, qualification readiness, training, regulatory readiness, and operational handoff activities.
Maintain project tools and documentation, including schedules, dashboards, risk registers, decision logs, action logs, and status reports.
Identify risks or blockers early, drive mitigation plans, and escalate issues requiring leadership support.
Prepare concise project updates, executive summaries, and decision options for sponsors and stakeholders.
Support coordination of hypercare and post-implementation activities to ensure smooth transition to business ownership.
Basic qualifications:
Doctorate degree or
Master’s degree and 2 years of experience or
Bachelor’s degree and 4 years of experience or
Associate’s degree and 8 years of experience or
High school diploma / GED and 10 years of experience
Top Must Have Skill Sets:
Global project/program management for complex technology implementations: Ability to manage integrated project plans, milestones, dependencies, risks, decisions, and governance across multiple workstreams and sites.
Quality Control / GMP operational knowledge in biotech or pharma: Working understanding of QC laboratory operations, regulated implementation activities, SOP updates, change controls, qualification, regulatory readiness, and data integrity expectations.
Cross-functional stakeholder leadership and executive communication: Ability to align site teams, QC SMEs, Quality, IT, Validation, Regulatory, and business stakeholders; facilitate decisions; escalate risks; and produce clear status updates for leadership.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
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