Project Manager

Project Manager

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

• 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.