Skills

Problem-solving Training Organization Project Management

Job Specifications

Duration of contract 18-24 month contract on site in Phillipsburg, NJ

About the Position:

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.

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.

Essential functions:

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.

Minimum requirements:

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.

Qualifications:

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.

About the Company

At Coda, we believe the best way to serve our clients is through an inclusive and personalized approach. We're not order-takers, we're consultants. Our clients and candidates receive "white-glove" treatment; in-depth interviews that explore, evaluate and evolve into solid solutions in order for them to find the perfect match for their career or staffing needs. We have access to a large network of talented professionals and industry leaders that provide unlimited opportunities for our clients. Simply put, we match the most ta... Know more