Note: The job is a remote job and is open to candidates in USA. Aditi Consulting is 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.
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
Skills
- Demonstrated experience running medium to large-scale projects
- Strong knowledge of project management processes and best practices
- Excellent analytical and communication skills
- Ability to work effectively across cross-functional teams and management levels
- 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
- 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
Benefits
- Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law.
- Full-time employees are eligible to select from different benefits packages.
- Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus.
- Sick leave and mobile phone reimbursement provided based on state or local law.
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