Location: Remote - Aliquippa, PA
Employment Type: Contingent Worker (Contract, W2)
Contract Length: 12 months (possible extension)
Compensation: $44/$48 per hour (based on experience)
Summary of the Role
Lead complex, global Quality Control technology implementation projects for a big biopharma leader in a regulated environment. Oversee cross-functional teams, manage integrated project plans, and ensure delivery of business, operational, and regulatory requirements. Drive alignment and communication across QC, Quality, IT, Validation, Regulatory, and site stakeholders through the project lifecycle.
Key Responsibilities
- Coordinate project team activities and align workstreams across global and site-level stakeholders
- Maintain integrated project plans, tracking milestones, dependencies, risks, issues, and actions
- Facilitate governance forums, cross-functional meetings, and decision-making sessions
- Support resource planning, business process analysis, and requirements gathering
- Oversee project documentation using tools such as MS Project, Excel, PowerPoint, Word, or Smartsheet
- Drive change management, training readiness, SOP updates, and regulatory/validation readiness
- Prepare executive-level status updates and summaries for sponsors and leadership
- Proactively identify and mitigate risks, escalating issues as needed
- Support operational handoff and post-implementation activities for business continuity
Required Experience & Skills
- Proven experience managing medium to large-scale technology projects in regulated biotech/pharma environments
- Strong knowledge of project management best practices and cross-functional collaboration
- Excellent analytical, organizational, and communication skills
- Familiarity with business process development and change management
- Proficiency with collaboration and project documentation tools (e.g. MS Project, Excel, PowerPoint, Word, Smartsheet or equivalent)
- Ability to manage multiple stakeholders and communicate technical concepts to varied audiences
Preferred Qualifications
- Experience with GMP Quality Control operations, laboratory systems, and data integrity
- Knowledge of SOPs, change management, qualification, validation, and regulatory readiness activities
Top 3 Must Have Skills
1. Global project/program management for complex technology implementations
2. Quality Control / GMP operational knowledge in biotech or pharma environments
3. Cross-functional stakeholder leadership and executive communication
Day-to-Day Responsibilities
- Manage integrated project plans for QC technology initiatives across global and site-level workstreams
- Coordinate with site project managers to track milestones, risks, decisions, and action items
- Facilitate project meetings and governance forums, supporting cross-functional working sessions
- Partner with QC, Quality, IT, Validation, Regulatory, and site teams to drive implementation activities
- Track progress against deliverables such as procedural updates, qualification readiness, and regulatory handoff
- Maintain project tools and documentation including schedules, dashboards, risk registers, and status reports
- Identify and escalate risks, ensuring effective mitigation strategies are in place
- Prepare concise executive project updates and decision documentation
- Support post-implementation and hypercare activities for business transition
Basic Qualifications
- Doctorate degree
- Master’s degree and 2 years of experience
- Bachelor’s degree and 4 years of experience
- Associate’s degree and 8 years of experience
- High school diploma / GED and 10 years of experience
This posting is for Contingent Worker, not an FTE