ob Duties:
- Establishes and maintains consistent project and portfolio management processes.
- Organizes a large body of work in an optimal way to ensure successful execution.
- Creates project strategies that integrate with broader departmental strategies.
- Converts ambiguous concepts into well-structured initiatives and projects.
- Defines, prioritizes, and develops projects designed to meet organizational goals and requirements.
- Optimizes resource allocation to the overall portfolio.
- Keeps stakeholders informed during remediation process
- Designs (and redesigns, if necessary) project plans to mitigate risks as appropriate.
- Ensure project tasks are carried out efficiently and effectively to meet goals and uphold standards.
- Implements system monitors and controls.
- Directs people who may or may not have reporting relationship with him/her or with each other
- Creates and maintains a documentation warehouse which meets company & regulatory requirements.
Skills & Knowledge:
- Strong mathematical/analytical skills required.
- Expert communication skills required, both written and verbal. Expert listening skills required.
- Expert presentation skills required. Breaks down complex subjects into simple dashboards and explanations.
- Expert at leading a diverse team to achieve goals. Expert at motivating people of diverse personalities to higher levels of performance.
- Skilled in the art, science, and discipline of project management.
- Knowledge of cGMP and FDA regulatory requirements for pharmaceuticals and med devices.
- Understands how to identify and benchmark best practices.
- Customer-focused mind-set.
- Skilled at setting key performance indicators (KPI's).
- Skilled at negotiation, persuasion, and influence.
- Strong financial acumen.
- Shows poise when performing under pressure.
- Understands advanced risk management practices.
- Power user of Microsoft PowerPoint, Word, and Excel.
- Preferred personality traits: intelligent, innovative, reliable, hard-working, organized, multi-tasking, results-oriented, relationship-builder.
Experience:
- Industry experience hierarchy:
- Experience in manufacturing required.
- Experience in FDA-regulated business required.
- Experience in FDA 483 remediation required.
- Experience in pharma and/or medical device industry preferred.
- Bachelor's degree in a technical field required; master's degree preferred.
- Experience managing people required.
- Experience in cost/budget management required.
- Experience in a structured Project Management Office (PMO) preferred.
- Experience in transformational/change management preferred.