Remediation/ PMO Director - OQSIE

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.