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Senior Consultant- FCX/PCI - Raleigh, NC

Location: 

Raleigh, NC, US, 27617

Company:  9290-FCX Performance, Inc

The Senior Consultant play pivotal roles in the organization by providing strategic client project initiatives, client proposal development and project oversight through specific, accurate, and detailed client proposals; realistic and achievable project timelines; along with budget and labor utilization awareness.  Senior consultants also play a vital business development role in which their thorough understanding of client processes results in additional client solutions being provided by other PCI service teams.  Through networking, extensive communication, and an awareness of ongoing client activities, Consultants are expected to develop, grow, and expand business partner relationships with clients with an awareness of when client needs might change, expand, or develop into other PCI service arenas.

 

The Senior Consultant is an exempt positions reporting to a Team Leader, Team Manager, Director depending upon organizational structure.  Up to 100% travel may be required. 

 

Expectations:

PCI Consultants are well respected Subject Matter Experts and called upon in the industry for their vast knowledge of key activities, processes and procedures and ability to share that knowledge in a professional way.  PCI Consultants also develop a true business partnership with all clients across various Life Science fields.  Consultants work closely with clients to research, identify, and provide effective long-term client solutions. They consistently uphold PCI Values and demonstrate Integrity, Accountability, Unified Team (Teamwork), and Creativity (Innovation).   

 

In addition to the above, Senior Consultants lead teams (internal or external) with both PCI and non-PCI team members.  They are accountable for overall project initiation, planning, implementation, monitoring, controlling and closure while ensuring the project is delivered on schedule, within budget, within scope and to customer satisfaction. 

 

 

Expectations and Responsibilities:

Senior Consultant

  • Acts as Account Manager.  Oversees multiple Project Leads and Project Managers.   Coordinates between multifunctional teams to obtain and assign resources and to develop schedules and activities to ensure that projects stay on schedule, within budget, within scope and are meeting or exceeding the client expectations. 
  • Defines project objectives, requirements, and assumptions necessary to structure a project or activity and translates them into scope documents or proposals.  Identifies out-of-scope activities and acts to document scope clarification and scope change documents.  Negotiates project changes and secures additional funding from the client prior to scope execution.  Reviews and approves scope change requests prior to submission to the client.
  • Oversees and manages multiple projects simultaneously
  • Cultivates client relationships and builds trust through professionalism and expertise at the Corporate level. Integrates into client and corporate environments in order to effectively lead projects with internal and external team members while building positive professional relationships with clients and associates. Proactively seeks to expand PCI services.  Proactively identifies opportunities for new business and translates them into clearly defined scopes of work to present to clients for approval and secure funding for proposed scopes.
  • Highly organized.  Sets up and utilizes PCI Customer Account Folders to retain all project related documentation, plans, schedules, KPIs and reference documentation.  Provides oversight and guidance to junior consultants to ensure PCI Account folders are utilized and maintained. Analyzes spend versus progress data to adjust resource loading to ensure project on-time delivery.
  • Works closely with client corporate global leadership to research and identify efficiency gaps and compliance risks and provide effective long-term solutions.
  • Subject Matter Expert.  Develops Life Sciences Industry related and technical training programs to present internally to consultants and externally to industry professionals in highly visible settings such as ISPE events.  Maintains a high level of proficiency by reading industry related periodicals and publications and participating on training and advisory boards of industry related organizations.
  • Creates corporate-level Account Plans and develops a clear overview that includes the account service history, client goals; needs; objectives, corporate organizational structure, risks, escalation process and specific client guidance for project execution and deliverables both globally and at each customer site.   Negotiates corporate-level service agreements such as Master Service Agreements.
  • Takes the lead to organize, develop and deliver Business Review Meetings that includes input from all PCI Service teams and includes high-level client personnel (Director level and above) and highlights additional areas where PCI can add value to the client’s organization.  Utilizes the BRM to learn about the client's initiatives, needs and future growth strategy and to develop PCI strategies to capitalize on additional business scope.
  • Performs Job Safety Analysis and proactively assess project safety concerns and ensures team members comply with industry, client and PCI site safety requirements.
  • Takes a leadership position in at least one professional organization (ISPE, PDA, NCSL, ASQ, etc.) to develop skills and maintain PCI's reputation as an industry leader by giving presentations, serving on committees, and other high-level functions within the organization. Drives engagement in the organization with junior team members.

 

Skills Required:

Senior Consultant

  • Acts as Account Manager.  Oversees multiple Project Leads and Project Managers.   Coordinates between multifunctional teams to obtain and assign resources and to develop schedules and activities to ensure that projects stay on schedule, within budget, within scope and are meeting or exceeding the client expectations. 
  • Highly skilled with Microsoft Word, Excel, PowerPoint, Visio and Project.  Can create complex formulas, easily manipulate formatting and develop innovative professional presentations to help monitor and control project execution.  Develops project status reports to present to senior leaders and decision makers.
  • Communicates with clients (Director Level and above) at a very high strategic level to build a foundation of trust, as well as have a thorough understanding of the specific details of the client processes.
  • Analyzes business processes, diagnoses inefficiencies, and conducts GAP analysis.  Proposes remedial action to correct issues uncovered in analysis. Drives the adoption of high value systems to address system problems (i.e. CMMS, CCMS, paperless systems, etc.) and create connections between the customer and other PCI partners for global strategic initiatives.
  • Analyzes work flows from multiple sites to simplify process flow diagrams at a strategic global level across multiple client sites.
  • Subject Matter Expert.  Leads teams in conducting System Impact and Component Level Criticality assessments. Recommends changes to clients to improve efficiency, reduce costs and reduce business risk.
  • Expert understanding of Calibration and Maintenance programs and regulatory requirements.  Analyzes corporate processes to implement compliant global calibration and maintenance programs.
  • Expert level understanding of Computer Validation System requirements.  Works with clients to identify user requirement specifications and develops detailed project plans for Computerized Maintenance and Calibration Management Systems (CMMS and CCMS) implementations
  • Excellent writing skills.  Reviews and approves SOPs, final reports and quality policies, procedures and guidelines   Ensures documents are accurate and compliant before final approval
  • Subject Matter Expert of GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines.  Ensures compliance as they relate to qualification of systems and validation of processes.  Reviews and approves programs and procedures and makes recommendations to reduce regulatory compliance risk and make processes more efficient.

 

Experience & Education Required:

Senior Consultant:  A four-year degree in Life Sciences, or other related technical field, or equivalent military training, and ten or more years of instrumentation experience in the Life Sciences industry.  Subject Matter Expert understanding of Quality Systems and the Life Science Manufacture industry is required.  Must be able to understand, interpret and apply all regulatory requirements and ISPE Good Practices guidelines.

 

A proven history of high-level project oversight and program management successes

proven track record of project and people management is required.         

 

In addition to the above, the Senior Consultant will also be a recognized Subject Matter Expert with an established track record and history of either publishing technical articles, whitepapers or other such documents; sharing technical expertise/knowledge through professional training and be a respected leader and authority figure in a related professional organization

PCI is proud to serve pharmaceutical, biotechnology, medical device, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions.  At PCI, calibrations are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2017. PCI is an FCX Performance Company and a Subsidiary of Applied Industrial Technologies (NYSE: AIT); a leading industrial distributor that offers more than 6.5 million parts to serve the needs of MRO and OEM customers in virtually every industry.

Applied® provides engineering, design and systems integration for industrial and fluid power applications, as well as customized mechanical, fabricated rubber and fluid power shop services. Applied also offers storeroom services and inventory management solutions that provide added value to our customers.

 

We are an equal employment opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, gender, sexual orientation, age, disability, protected veteran status, marital status, medical condition or any other characteristic protected by law.


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