Senior Project Manager
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Senior Project Manager to be part of our client’ s team in Vacaville. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Senior Project Manager
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Maintains full understanding of program milestones for the Core, Lifecycle, Technical Development and associated teams and links them to the Device Team plan
- Effectively applies PM best practices and utilizes tools for planning, communication, team building, collaboration, decision-making, issue & risk management, lessons learned, knowledge management and budget tracking
- Develops & updates Design & Development Plan and establishes contingency plans as needed
- Ensures transparent communication of key team information and escalates issues as appropriate
- Establishes positive team dynamics through team building
- Promotes collaborative environment across team members
- Facilitates efficient decision-making and issue resolution
- Identifies team risks and mitigation plans
- Proactively manages project and team to achieve deliverables and solve issues.
- Manages project scope and facilitates project changes as required
- Leads project plan development and execution
- Develops, monitors, and controls the detailed project schedule
- Drives change for improved efficiency and/or optimization
- Facilitates effective decision-making and escalation of issues
- Integrates project deliverables with other Teams linked to product (e.g. TDT)
- Integrates external collaborator plan(s) with Device Team project plan
- Anticipates and manages risks efficiently using proactively defined contingency plans as appropriate
- Leads the Device Team project risk management process using the TDT Risk Management Tool
- Facilitates and lead Team issue and conflict resolution
- Assesses Team dynamics and leads team building activities to enable and sustain a high performing team environment
- Establish relationships and network with other stakeholder Teams and PMs
- Develops and adapts project communication tools to drive awareness of project progress and risks across stakeholders including external collaborators (e.g. dashboard)
- Acts as Device Team Leader back-up for Team communication as required
- Liaises with other Teams to manage cross-functional activities and issues and risks
- Effectively facilitates Team meetings with meaningful desired outcomes, appropriate participants, minutes, actions and follow up
- Participates in CMO and Partner meetings and integrates relevant outcomes into project plan
- Actively forecasts and monitors Device Team resource (FTE) and project variable costs (PVCs)
- Establishes centralized Team access to all relevant project information
- Manages Team uncontrolled document repository (e.g. Project History File)
- Conducts lessons learned exercises during project execution and share outcomes to a broader audience
- Effectively navigates the Device Team through business process stage-gates
- Supports Team Leader with technical advisory and governance committee reviews at pre-defined check-in points and/or identifies appropriate check-in points
- Leads business process continuous improvement initiatives through applying project lessons: business process updates, PM tool optimization & implementation, best practice sharing and driving awareness across teams.
- Effectively applies Quality System and Roche PQS requirements for team activities and deliverables
- Facilitates planning and maintains the Design and Development Plan (DDP) with Team input
- Oversees Design Review planning, execution and closure of actions and completes DHF records
- Effectively utilizes e-document system to maintain Design History File in compliance with PQS requirements
- Supports internal and health authority audits as required
Summary of Qualifications:
- B.S. or B.A degree, preferably in Engineering, or the equivalent.
- At least 8 to 11 years’ experience with at least 5 years relevant industry experience, preferably a multi-site global company in the medical device, pharmaceutical or biopharmaceutical, after receiving Bachelor’ s degree
- Drug and/or Medical Device development & commercialization experience preferably with Combination Products
- Project Management best practices: communication, scheduling, budget & resource planning, team building and risk management
- PMP certification considered an asset
- Solid knowledge and understanding of 21CFR820.30 design control requirements
- Software tools: Microsoft Office (Project & Excel), Google, WebEx, Visio, Planisware
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment
- Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building) required
- Ability to effectively communicate in a highly matrixed organization and with external parties