Job Description
Job Title:
Project Manager Location:
Remote Duration:
12 months 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 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. Ideal Candidate:
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. 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 3 Must Have Skills:
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. Possible Extension:
Yes Red Flags:
Limited experience in biotech, pharma, medical device, or another regulated environment. Frequent short assignments with unclear deliverables or outcomes, unless explained by contract/project-based work. Purely agile/software delivery background without experience coordinating business process, operational readiness, procedural, training, and site deployment activities. Lack of demonstrated experience managing cross-functional implementations involving multiple sites, workstreams, or stakeholder groups. Interview Process:
One MS Teams Virtual Interview (Cameras on) with HM for 1 hour. One MS Teams Virtual Interview (Cameras on) for 25 minutes.
