Our global SaaS client seeks an Project Implementation Manager contractor.
This is an onsite role local to Phillipsburg, New Jersey.
The Project Implementation Manager works closely with members of the Corporate and Site Quality teams as well as manufacturing, technical, engineering and commercial functions as required. The Project Implementation Manager is accountable for a portfolio of projects in support of the client’s growth initiatives and continuous improvement activities. Projects can involve new production or testing capacity, product transfers, customer qualification & support, internal process improvements and compliance related programs. Project Implementation Manager are responsible for coordinating internal resources and/o third parties/vendors for the development, planning and execution of projects in their portfolio on time, within scope, within budget and to ensure compliance with regulatory requirements such as cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements.
Contract Duration: 18 - 24 Months
Required Skills & Experience
- Experience managing projects and programs to conclusion; Project Management training required with certifications a plus.
- Experience in Quality, Regulatory Affairs, or IT systems developing and managing programs associated with such.
- Bachelors degree with an advanced degree a plus.
- Minimum of 5 years in regulated industry or related role within the chemical, pharmaceutical or biotechnology
- Strong background in regulated environment including GMP regulations, ISO9000 and/or regulatory affairs.
- Background and knowledge of systems and software applications
- Demonstrated ability to accomplish goals through others.
- Demonstrated familiarity with numerous regulations including cGMPs, ISO, Import/Export, FDA requirements such as 210/211 Part 11 and regulatory needs.
- Highly detail oriented with demonstrated strong analytical and problem-solving skills - Excellent verbal and written communications skills including the ability to communicate at all levels within the organization Ability to navigate in a matrixed environment and work collaboratively in a team environment.
- Education: Bachelor's degree in business, Project Management, Scientific or Engineering discipline or a related field required
- Minimum of five (5) years of experience in project management role required, preferably in the Life Science field focused on Quality and regulated industry compliance. Experience with gated project/program management.
- Demonstrated experience handling multiple projects and tasks while producing timely and high-quality deliverables
- Excellent prioritization, organization and project management and task management skills
- Proven analytical/problem solving skills; ability to analyze and effectively communicate analysis recommendations.
- Ability to handle and prioritize multiple projects and manage deadlines with demonstrated drive for results Strong management capability; able to plan and adjust team resources dynamically across the lifecycle of the project.
- Strong interpersonal and people management skills to ensure effective teaming/collaboration across the project team. Ability to lead and motivate personnel and cultivate a team mentality.
- Ability to interact and obtain visibility/buy-in across the organization/senior leadership.
- Ability to provide cross-functional project leadership and manage work through team members that are not direct reports.
- Ability to facilitate communication and collaboration across disparate teams without direct ownership to achieve program directives.
- Functional knowledge of Microsoft Outlook/Word/Excel/PowerPoint/Visio/Teams
- Strong communication skills, both written and verbal.
- Ability to prioritize functions, ensure on time completion or required tasks, and manage time effectively
What You Will Be Doing
Daily Responsibilities
- Collaborating with stakeholders both internally and externally to develop and plan project scopes and objectives.
- Develop a detailed plan to track progress, monitor progress and ensure successful project delivery.
- Measure project performance using appropriate systems, tools, and techniques and enter all project-related information into product development software tracking tool.
- Effectively communicate relevant project challenges or roadblocks to senior management through proper issue escalation
- Schedule, organize and lead team meetings to assess progress against functional task list and timelines.
- Identify, prioritize, and mitigate project risks.
- Ensure the effective preparation and delivery of all project events and meetings; ensures production of all necessary documentation within each phase.
- Assist teams prior to tollgate/milestone meetings to ensure readiness to proceed to next stage of a project.
- Participate and/or lead tollgate/milestone meetings designed to assess progress and readiness to proceed to the next stage of a project.
- Lead root cause/countermeasure process to mitigate any scope/quality/timing/budget issues and ensure projects remain on track.
- Performs other duties as assigned with or without accommodation
