We are looking for a Senior Staff Program Manager to join our growing Life Cycle Management (LCM) team. The LCM group works as an integral part of our manufacturing process and is tasked with driving equipment management strategy within our production environments.
This individual will be responsible for driving project execution across a portfolio of infrastructure projects that support our design transfer process. Projects are focused on improving capability, innovation and quality. Candidates will benefit from a strong understanding of development and manufacturing activities for IVD regulated products. The successful candidate must be able to work independently, handle multiple projects in parallel, and communicate effectively across all levels of the organization.
- Responsible for obtaining, clarifying and aligning requirements and developing project plans.
- Manage cross-functional programs including resources, project timelines and project budgets required to successfully drive projects and initiatives.
- Interact and drive project efforts across cross-functional teams including: Research & Development (R&D), Manufacturing, Life Cycle Management (LCM), Information Technology (IT), Quality and Regulatory Affairs.
- Set priorities, develop work breakdown structure and monitor progress towards project goals.
- Track details and activities across projects to ensure alignment with long term business objectives.
- Present projects and program level plans to senior management and provide regular updates throughout the project management lifecycle to effectively manage expectations of progress against planned commitments.
- Identify root cause, manage and resolve issues when possible or escalate risks/problem situations to ensure projects remain on schedule and on budget.
- Learn and understand the technology and engage in technical discussions.
- Identifies new capabilities, processes and initiatives
- Provide regular reports to management.
Requirements and Education:
- Typically requires a minimum of 8years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
- PMP certificate is a plus.
- Experience in product development processes is a plus.
- Diagnostic industry experiencepreferred.
- Experienceapplying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD) is required
- Demonstrated ability to accomplish goals while working across departments.
- Experience working in regulated environments - ISO and GMP
- Highly effective communication, facilitation, negotiation and teamwork skills are required
- Ability to influence cross functional resources and leverage resources in a heavily matrixed environment.
- Proven ability to identify key issues, motivate and empower others to address them in a way which builds morale, generates ownership and commitment.
- Track record of strong organizational skills along with a high degree of detail orientation to ensure quality work product
- Self-starter with strong problem-solving, quantitative and qualitative analytical skills and a track record of high performance and superior delivery.
- Possess leadership, time management and decision-making skills
- Demonstrated ability to execute and organize and lead efforts to influence organizational change.
- Adaptable to fast-paced, dynamic work environment with shifting demand
- Must be able to provide solutions that reflect an understanding of business objectives and cost implications