Position Details:
Job Summary
The Associate Director Project Management will provide project management support to medical device (MD) and combination product (CP) compliance efforts for the creation of an efficient and sustainable compliant environment for MDs and CPs.
The skill set for the AD role is to manage cross-functional project teams, establish appropriate strategies and plans to meet the strategic goals of the project(s), develop and maintain appropriate project charters and drive priorities/task assignments in-line with overall objectives/goals. The project structure will follow the Plan-Do-Check model:
• Plan – Conduct comprehensive gap assessments, prioritize gaps, and generate risk-based remediation plans
• Do – Complete risk-based remediation activity
• Check – Verify effectiveness through internal audits and mock inspections
• The AD is able to manage extremely complex issues with the team, through analysis of intangible variables requiring high degree of creativity & innovation.
• He/she will navigate teams through difficult activities & challenges, independently identifying and applying effective PM principles to develop resolution plans expeditiously.
• The AD is also responsible for building and maintaining project plans, schedules, and performance reports.
• The AD of Project Management must be prepared to both independently lead cross-functional teams or to provide program management support for projects where someone else serves as the Lead.
• Additional responsibilities include:
• Provides complex scenario analysis for issues with significant business impact
• Exercises judgment within broadly defined practices in selecting methods, techniques & evaluation criteria to obtain results
• Recognizes opportunity for improved department objectives and approaches, based on professional principles and theories
Additionally, The AD of Project Management shall collaborate with project managers from within the Tech Ops PMO to advance the culture, capability, and value proposition of the Tech Ops PMO. He/she will foster standardization and communication of the Tech Ops PMO tool set and processes and provide project management tools and coaching on project management tools/ methodologies to functional teams as needed.
The AD will report to the Director of Project Management within the Tech Ops PMO team.
80% Responsibilities
• Establish and lead teams to effectively solve complex business, process or scientific challenges developing an appropriate and improved future state for the compliance of medical device and combination products with applicable requirements (including 21 CFR Part 820, ISO 13485, ISO 14971, and Medical Device Directive 93/42/EEC).
• Define project’s scope, resource requirements and timeline.
• Develop project plans utilizing project management and other applicable tools.
• Responsible for keeping the projects on track and in scope.
• Responsible for identifying and finding solutions to resource conflicts and appropriately alerting management if issues cannot be resolved.
• Identifying project tasks/deliverables and keeping responsible individuals accountable.
• Work with 3rd party external consultants on assessments and action plans as required.
• Develop and maintain schedules, timelines, milestones, and performance reports.
• Lead the development of proposals, project charters and/or business cases for project approvals. Enter, maintain, and update project plans.
• Ability to closely collaborate with leaders and SMEs across Tech Ops organization. Provide input and updates to the Head of PMO.
20% • Organize, facilitate, and document project meetings.
• Track progress towards accomplishing project milestones and deliverables.
• Make assignments and monitor effectiveness.
• Communicate with project team members on status of assigned action items and provide support for resolving issues.
• Ensure all project documentation is current and complete.
Education & Experience Requirements
• Minimum of a four year Bachelors Degree, preferably in life sciences, business or engineering (or equivalent experience).
• Masters Degree is a plus.
• PMP certification desirable.
• Minimum 12+ years Project Management experience including 2+ years of portfolio management experience, and 6-10 years in industrial operations.
• Biotechnology / pharmaceutical industry, knowledge of both medical device and pharma/biopharma Quality Systems a plus
• Knowledge of Medical Device requirements 21 CFR Part 820, ISO 13485, ISO 14971, and Medical Device Directive 93/42/EEC
• Experience working with Combination Product Quality System requirements a plus
Key Skills and Competencies
• Strong leadership and organizational skills.
• Ability to influence others and work cross-functionally.
• Outstanding communication skills including the ability to interact with all levels of management including Tech Ops Leadership Team.
• Must be able to succinctly communicate complex problems and proposed solutions both in writing and orally.
• Must be proficient in the application of appropriate project management tools (MS Project, PowerPoint, Word, Excel).
• Proven ability to learn quickly and get up to speed on a variety of complex issues.
• Must be able to understand how the project fits into the overall operations and company strategy. Functions well under pressure in a changing environment.
• Uses independent judgment to identify, plan, prioritize, and organize diversified workload as required.
Other Job Components
Problem Solving Skills
• Advanced problem solving capabilities required.
• Must be capable of understanding a broad range of projects, distinguish priorities and articulate requirements across all functions of the company.
• Must be able to align projects against the backdrop of long term product and/or Company strategies