Senior Manager

Description:

Here at the OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease.

This role at OraSure Technologies is a unique and dynamic position that combines the responsibilities of both a Program Manager and a Project Manager. This role is responsible for managing multiple, diverse product development projects through prioritization, timelines, resources, budget, and deliverables. The position demands a proven leader who can manage complex projects from inception to close-out, collaborate across diverse cross-functional teams, and navigate complex strategies and project interactions.

You will oversee multiple project teams, ensuring that program goals are reached, and organizational objectives are met. You will develop and maintain program initiatives, manage budgets, and produce program reports for managers and stakeholders.

Additionally, you will apply product life cycle methodology to the New Product Introduction (NPI) process, plan and define project scope, coordinate with Product Managers, manage project resources, and ensure that project deliverables meet required regulations, standards, and specifications.

This role ensures that all goods manufactured and services provided by the Company meet user and customer needs, conform to the quality procedures and requirements of the Company, and meet applicable US and international regulations and standards.

The position is hybrid or remote, with occasional on-site work at the Bethlehem, PA, Newton, MA, Ottawa (Canada), Cambridge, UK, and/or Oxford, UK facilities. Preference will be given to candidates located within commuting distance of Bethlehem, Newton, or Ottawa offices.

Snapshot Of Responsibilities

Oversee multiple project teams, ensuring program goals are reached
Strategize, implement, and maintain program initiatives that adhere to organizational objectives
Develop program assessment protocols for evaluation and improvement
Maintain organizational standards of satisfaction, quality, and performance
Manage budget and funding channels for maximum productivity
Work closely with project sponsors, cross-functional teams, to develop the scope, deliverables, required resources, work plan, budget, and timing for new initiatives
Identify key requirements for cross-functional teams and external vendors
Develop and manage budget for projects and be accountable for delivering against established business goals/objectives
Analyze, evaluate, and overcome program risks, and produce program reports for managers and stakeholders
Apply product life cycle methodology to the New Product Introduction (NPI) process in collaboration with the project team
Plan and define project scope, including establishing objectives, deliverables, and timelines
Coordinate with Product Managers and lead cross-functional teams in planning, execution, and communication of key project deliverables
Manage project resources, including allocation and management of team members, budget, and equipment
Identify potential project risks and develop strategies to mitigate them
Keep stakeholders informed and engaged throughout the project
Lead and motivate the project team to achieve project goals
Ensure that project deliverables meet the required regulations, standards, and specifications
Monitor project progress as well as maintain clear and regular communication with cross-functional groups and stakeholders
Provide updates to supervisors regarding project status and design control requirements
Present program status to senior management for review and approval
Facilitate problem-solving and decision-making processes while addressing and resolving project-related issues in a timely and efficient manner
Track and control project expenses to stay within budget
Maintain comprehensive project documentation for future reference and audits
Generate and maintain project management and design control documents, including plans, design control/product realization deliverables tracking, schedules, resourcing, timelines, and budgets
Ensure product development timeline and deliverables meet commercial needs for market launch, including product claims, market research, and KOL studies/communication
Ensure compliance with relevant regulations and quality standards, including but not limited to U.S. Code of Federal Regulations for Medical Devices, European In Vitro Diagnostic Directives/Regulation, EN/ISO 13485, IEC 62304, and IEC 62366
Manage and track product changes
Ensure core team personnel understand and comply with the requirements of New Product Development, Design Control, and changes to existing products as applied to the Company’s products
Support compilation of design history files and contents for technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to meet Company products and regulatory requirements, and compliance with all approved licenses
Participate in the investigation of failures and execution of continuous improvement initiatives
Write and maintain procedures relating to product development, the preparation and presentation of reports, data, and Key Performance Indicators for management reviews
Maintain current knowledge of related industry trends and regulations as well as integrate lessons learned
Comply with the Company’s Quality Systems along with other obligations deemed appropriate for a Project Manager

What You Bring

Minimum of 8 years’ experience in vitro diagnostics (preferred), medical devices industry
Demonstrable track record in product development with increasing responsibility leading to management of complex projects and launching new capabilities to market
Experience with regulatory submissions (e.g., 510(k), PMA)
A completed 3 or 4 year college diploma or university degree in one of the following areas: Quality, Science (chemistry, biology, or medical technology), or Engineering
Desired experience in product development, for example as a contributing engineer or scientist
Experience with design control processes for medical devices and related processes
Deep understanding of project management methodologies and techniques with practical experience using project management tools (i.e., Microsoft Project)
Proven ability to drive project governance and hold cross-functional teams and project leaders accountable for meeting established objectives
Strong analytical and problem-solving skills with the capability to simplify complex issues and mitigate accordingly
Competency with internal and external audit processes
Proficient use of basic computer software (Microsoft Office preferred)
Excellent verbal and written communication skills with presentation capabilities
Project Management Professional (PMP) certification considered an asset
Ability to travel based on business need (less than 15% of the time)