Operations Project Manager

How We Make an ImpactOraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. We are a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions around the world.How You Will Make an ImpactYou will be responsible for planning and leading projects to support Operations department which may include but not limited to manufacturing capacity expansion (facility and manufacturing equipment), and other projects to improve the quality and efficiency of existing manufacturing processes. Specific responsibilities will include the development and management of a detailed project plan and risk register and guiding the team through OraSure''s change control processEssential Duties and Responsibilities* Developing a project plan, managing timelines, and providing updates through regularly scheduled meetings with key stakeholders and functions.* Actively obtaining updates from all stakeholders (both internal and external) to ensure project plan/timeline is accurate and up to date.* Developing and maintaining a risk register to identify and manage risks to the overall success of the project* Develop, standardize, and maintain processes, protocols, checklists, templates, approval processes, critical timelines, and other project management documentation to achieve business goals.* Take initiative to create policies and execute initiatives regarding organization''s project management process improvements.* Lead cross functional team collaboration efforts; manage expectations, timelines, and deliverables through coordination across project team resources.* Minimize pain points, improve cross functional team communication, and drive accountability across the project team* Lead project kickoffs, internal and external status meetings* Project change impact analysis (i.e., out-of-scope requests/scope creep)* Identify and mitigate project resource needs, by reallocating resources, adjusting goals, or assigning additional staff and Interface with department managers as needed for resource management.* Manage project communications to all stakeholders (project teams, functional managers, internal and external customers, and senior management), including meeting minutes, monthly updates, communications meetings, and phase reviews* Monitor project scope and critical path, identify potential bottlenecks and work with relevant stakeholders to make schedule adjustments* Schedule and lead regular meetings to coordinate inter-departmental project activities to resolve project issues.* Maintain compliance with all GMP and OraSure Quality System requirements.* Execute special projects and initiatives as requested by OTI leadership.* Mentor and assist with training of project management tool, techniques and methodology to project staff as required* Manage stakeholder relationships, with focus on meeting client expectations* Lead cross-functional teams. No direct line management responsibility* May manage project coordinators as needed.QualificationsDemonstrated ability to lead a team required.Ability to work in a fast paced, constantly evolving environment and competing prioritiesExperience managing project and leveraging resources in matrix organizationsExceptional organizational skills and ability to manage multiple priorities required. May have to manage multiple projects concurrently.Experience leading manufacturing facility and equipment capacity expansion projects is required.Experience building productive, collaborative relationships with external suppliers required.Demonstrated proficiency utilizing Microsoft Project and/or Smartsheets required.Good understanding of Quality System Regulations as pertains to Medical Device manufacturing including change control, risk analysis, and validation requirements for facility modifications and equipment required.Experience with equipment, mold, and process validation (including review and approval of IQ, OQ, and PQ protocols) a plus.Experience with projects requiring the purchase, commissioning, and validation of capital equipment (facility and/or manufacturing) a plus.Education AND/OR ExperienceB.S. in Engineering preferred (ME, MfgE, IE, or Chem E.)Five years of experience leading projects in an FDA regulated environment.Experience leading government funded projects (i.e. BARDA, DOD, etc.) is a plus.Experience in life science, Med Tech, IVD projects is preferredConstruction management experience is preferredPMP, PgMP, CAPM, and/or comparable project management certifications highly desirableOraSure and its subsidiaries is committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.Featured benefitsEmployer-providedMedical insurance, dental insurance, vision insurance, 401(k), paid maternity leave, and paid paternity leave

Created: 2025-10-04