Project Manager

Company Description

IRI believes in commitment, integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.

Job Description

Summary: 

Provides tools and methods and aligns cross-functional plans for the management of products within the Donor Screening business. 

Develops project plans, ensures transparency and clarity of overall project goals, and ensures linkage to overall new product development plans to drive delivery of project on-time, scope, quality, and budget. 

Responsibilities: 

• Works closely with Core Teams, Product Managers, Project Managers and Project Leads. Monitors team progress and holds team members’ accountable for their deliverables.

• Uses appropriate project management processes, the PDS and the Change Control Process. Recommends improvements for greater efficiency and effectiveness in new product launches.

• Order fulfillment – ensure that a customer order may be won, received, processed, & executed through our systems

• Regulatory readiness – drive QRC to ensure all submissions are completed, technical files is completed, DoCs completed, and any other country-specific commercial requirements are met

• CTS readiness – ensure that training materials/tools are approved/translated and training has occurred in-Region & within Customer SVS

• Technical Communications – ensure all user docs, customer letters, release notes, new parts lists, forms, IFUs, guides, etc. are planned, generated, approved, translated, and ready for use

• Support Manufacturing Readiness in all current factories – drive Ops to ensure all packaging, labeling, and other kits, components, accessories are set up for procurement, manufacturing and ordered in sufficient quantity/time, codes set up, fcsts loaded, MSDS created

• Supply readiness – work through Ops to ensure warehouse(s) are set-up & inventory is available to fulfill orders and matches demand plan

• Develops project plans, where necessary, and ensures transparency and clarity of overall project goals. Ensures linkage for any in-market product changes that impact the customer. Drives delivery of project on-time, scope, quality for:  

• Product changes that affect the customer use of product, such as assay modifications, product configuration changes, media releases, technical and customer communications.

• Routine updates of Customer Documentation (IFU’s, Manuals, package and other labeling)

• Coordinates corrections stemming from Quality Improvements including recalls, field corrections, customer documentation updates, and customer letters as directed by Quality. Creates “Implementation Plans” and resulting documents that are part of formal compliance files and often audited by regulatory agencies.

• Coordinates the discontinuance of product offerings

Accomplishes the above by:

• Following all existing SOPs and guidance documents in the Product Development Process and Change Control Process.

• Leading appropriate cross-functional teams with representatives from R&D, Quality, Regulatory, Tech Transfer, Compliance, Operations, Demand and Supply Planning, Customer Service, Customer Technical Services, Product Management and other organizations as necessary to:

• Drives cross-functional collaboration, communication and change management activities for flawless execution of product launches and changes, operational efficiency and functional accountability.

• Identifying risk and planning for it. Facilitating problem solving and decision making.

• Achieves results through team members with significant latitude and independence. Achieves results through knowledge, experience, trust, and credibility without direct organizational authority.

• Errors or lack of timely action would result in delays of critical new product launches, recalls and other field action corrections, with significant financial and/or compliance impact.

Qualifications

Qualifications: 

• At least 5 years’ experience in a regulated or GMP environment required in the areas of Tech Transfer, R&D, Manufacturing, Operations, Supply Chain, Tech Support, Quality or Project Management

• Demonstrated project management skills – objectives, scoping, deliverables, timeline development, responsibility assignment, tracking

• Strong soft project management skills – ability to clarify, question and delegate appropriately

• Ability to maneuver in a highly complex environment

• Desire to learn about product launches from an operational perspective from many different business functions

• 4-year college degree. 

Additional Information

Regards,

Sweta Verma

IT Recruiter

Integrated Resources, Inc.

Inc. 5000 – 2007-2015 (9th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

(Direct) 732 549 5907 | (W) 732 -549 - 2030 x 210| (F) (732) 549 5549