Systems Consultant/Engineering Director jobs in Anderson, IN

Systems Consultant/Engineering Director oversees the design of enablement plans and configuration specifications and installation operations to implement integrated hardware and software systems and products purchased by customers. Develops standard processes and methodologies to prototype and test proposed solutions for feasibility, reliability, and quality. Being an Systems Consultant/Engineering Director directs the development of program and system specifications to meet customers' technical requirements and guide the enablement, configuration, or coding of products and solutions. Ensures the delivery of technical information, documentation, requirements, and cost estimates to sales teams to use in proposals, quotes, and statements of work meet sales cycle and project timeline requirements. Additionally, Systems Consultant/Engineering Director requires a bachelor's degree. Typically reports to senior management. The Systems Consultant/Engineering Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be an Systems Consultant/Engineering Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (Copyright 2024 Salary.com)

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Associate Director, Quality Systems
  • POINT Biopharma
  • Marion, IN FULL_TIME
  • Overview

    POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.

    TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

    The Associate Director of Quality Systems is responsible for overseeing the continued development, improvement, execution, and oversight of the Quality Management System (QMS) to ensure compliance with all EU, ISO, and FDA standards.

    The Associate Director of Quality Systems will work across the POINT organization to lead day-to-day activities in document control, training, Key Performance Indicator (KPI) tracking and trending, and quality management review while remaining current in regulatory expectations for Quality Management Systems.

    The position is based on-site in Indianapolis, Indiana, U.S. and directly reports to the Vice President, Quality Operations and QMS

    Objectives

    Contribute to the achievement of the company’s strategic goals by providing oversight for all Quality Management Systems and leading a team consisting of QA Specialists, QA Administrators, and Training Coordinators.

    Ensure technical review and approval for documents, including deviation/complaint investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, personnel qualification strategies, control strategies, technical studies, etc.

    Performance management and development of staff.

    Partner within Quality Assurance and across functional disciplines to influence and implement the site business plan and GMP Quality Plan objectives

    Interact with regulators and other external stakeholders on business issues and continuous improvement activities.

    Define strategic direction of the Quality Management System

    Network internally and externally to share best practices, rationale, and control strategies to continuously improve local systems and business processes.

    Ensure that the Quality Management System remains compliant with cGMP as defined within FDA CFR 21, part 210 and 211, EU Annex 1, ICH and USP relevant chapters for pharmaceutical products.

    Select, lead, and develop a team that successfully executes the following critical business functions in support of Quality and Compliance:

    Employee training

    Document control

    Electronic QMS administration

    KPI tracking and trending

    Quality management review

    Electronic and hard copy data management

    Data integrity program

    Accountabilities

    Collaborate with and provide functional leadership and support to the broader Quality Assurance team.

    Contribute to the development, maintenance, and continuous improvement of the POINT QMS, including Change and Deviation Management

    Ensure that production, testing, handling, and release of drug products are in compliance with documented procedures and specifications as well as external regulatory requirements.

    Requirements

    Education and Experience:

    Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or related field

    7 years of experience in Quality Assurance in a pharmaceutical manufacturing environment.

    Critical Competencies:

    Experience managing Quality Assurance within a GMP pharmaceutical manufacturing environment

    Experience in regulatory inspections (FDA, EU, ISO, etc) pertaining to Quality Management Systems

    Hands-on experience with authoring and approving quality documentation (SOPs, Training Records, Audit Agendas, Audit Reports, Key Process Indicator Reports, Annual Product Reviews, Deviation/Change Management)

    Ability to plan, develop and execute multiple projects under tight timelines.

    Excellent communication skills, including preparation of technical and executive summaries.

    Operate and execute with a sense of urgency.

    Ability to influence and lead diverse groups, complex regulatory, business, and technical groups

    Technical leadership, administrative and organizational skills

    Ability to build relationships with internal and external customers

    Proficiency in delivering complex tasks and/or tasks that are highly cross-functional

    Demonstrated Project Management skills and ability to coordinate complex projects

    Ability to communicate and influence effectively across functional groups and stakeholders

    Strategic thinking and ability to balance short term needs with long term business evolution

    Why joining POINT today will be the right career move for you:

    There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

    • You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year

    • You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win

    • You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company

    • Most importantly, you will spend everyday working on something important

    If what we are saying resonates with you, please submit a resume.

    Benefits

    Health Care Plan (Medical, Dental & Vision) – 85% paid by employer and effective day 1

    Retirement Plan (matching 401k)

    Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid

    Voluntary Income Protection – Premiums paid by employee

    Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)

    $500 fitness reimbursement per year

    $50 cell phone reimbursement per paycheck ($1,300 per year)

    All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

    POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

    We do not accept unsolicited inquiries or resumes from agencies.

  • 11 Days Ago

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Director of Nursing- DON
  • Magnolia Health Systems
  • Marion, IN FULL_TIME
  • Company Overview Twin City Healthcare, a skilled nursing facility in Gas City, IN, is committed to residents and employees. Twin City Healthcare provides the upmost quality of care to residents by sel...
  • 18 Days Ago

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Social Service Director
  • Miller's Health Systems
  • Logansport, IN FULL_TIME
  • Company Description Since 1964, Indiana families have looked to Miller's Health Systems for compassionate care for their loved ones. This once family owned and operated company evolved over time to ex...
  • 19 Days Ago

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Assistant Director of Nursing - ADON - RN
  • Magnolia Health Systems
  • Hartford, IN FULL_TIME
  • Company Overview Bridgewater Rehabilitation Centre, a skilled nursing facility in Hartford City, IN, is committed to residents and employees. Bridgewater Rehabilitation Centre provides the upmost qual...
  • 18 Days Ago

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Systems Analyst
  • eKeeper Systems
  • Yorktown, IN FULL_TIME
  • Hybrid work environment – Week-long rotations in office or at home. Client onsite responsibilities as needed. Yorktown, Indiana, United StatesJoin a Rock Star TeamSmall company attitude with big compa...
  • 12 Days Ago

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Systems Analyst (Levels I and II)
  • eKeeper Systems, Inc.
  • Yorktown, IN FULL_TIME
  • Join an Elite IT Team Small company attitude with big company benefits, if you are looking for a Systems Analyst position with an elite IT team that believes in unparalleled excellence, you’ve found i...
  • Just Posted

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0 Systems Consultant/Engineering Director jobs found in Anderson, IN area

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Product Development Engineer (16940)
  • Belden
  • Indianapolis, IN
  • Belong. Believe. Be You. Belden. Propel your career surrounded by a diverse team of innovative, goal-oriented individual...
  • 3/18/2024 12:00:00 AM

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Solutions Team Leader
  • Emarsys UK Ltd
  • Indianapolis, IN
  • Solutions Team Leader Indianapolis **Solutions Team Leader** Indianapolis Emarsys are an international SaaS group of sha...
  • 3/18/2024 12:00:00 AM

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Warehouse Industrial Engineer
  • Bridgewaypro
  • Indianapolis, IN
  • Location Indianapolis, IN **TITLE**: Warehouse Industrial Engineer **LOCATION:** Indianapolis or Chicago, Dallas/Ft. Wor...
  • 3/18/2024 12:00:00 AM

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Adjunct Faculty, Department of Musical Theatre and Theatre
  • Anderson University
  • Anderson, IN
  • Job Details Job Location Main Campus - Anderson, IN Description The School of Music, Theatre, and Dance at Anderson Univ...
  • 3/16/2024 12:00:00 AM

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Automation Technician
  • Crew Carwash
  • Fishers, IN
  • We are honored to be a Glassdoor's Best Place to Work Recipient for 2024, our 5th year in a row! Crew Carwash Honored as...
  • 3/15/2024 12:00:00 AM

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Technical Sales Associate Key Accounts
  • Careerbuilder
  • Fishers, IN
  • Securitas Technology, part of Securitas, is a world-leading provider of integrated security solutions that protect, conn...
  • 3/15/2024 12:00:00 AM

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Sr. Director Growth, Cloud Professional Services (REMOTE)
  • Acxiom LLC
  • Indianapolis, IN
  • Acxiom is currently seeking sales professionals to join our expanding cloud services organization. In this role, you wil...
  • 3/14/2024 12:00:00 AM

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Regional Environmental Manager
  • Lennar Homes
  • Indianapolis, IN
  • Overview Welcome Home! Build your career with Lennar! As one of the nation’s largest builders, Lennar has built over one...
  • 3/14/2024 12:00:00 AM

Anderson is a city in and the county seat of Madison County, Indiana, United States. It is the principal city of the Anderson, Indiana Metropolitan Statistical Area which encompasses Madison County. Anderson is the headquarters of the Church of God (Anderson) and home of Anderson University, which is affiliated with Christian denomination. Highlights of the city include the historic Paramount Theatre and the Gruenewald Historic House. The population was 56,129 at the 2010 census. This is down from 70,000 in 1970. Anderson is located at 40°06′00″N 85°40′53″W / 40.100041°N 85.681525°W / 40.10...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Systems Consultant/Engineering Director jobs
$207,420 to $263,475
Anderson, Indiana area prices
were up 1.3% from a year ago

Systems Consultant/Engineering Director in Helena, MT
A bachelor’s degree in computer science or IT management is generally required for a system consultant role, but employers often hire job candidates with lower degrees if they have practical experience.
December 08, 2019
Systems Consultant/Engineering Director in Lawrence, MA
System Architect/Engineering is responsible for defining and communicating a shared technical and architectural vision for an Agile Release Train (ART) to help ensure the system or Solution under development is fit for its intended purpose.
November 30, 2019
Systems Consultant/Engineering Director in Hartford, CT
See the SEG Requirements Engineering topic for a discussion on eliciting, analyzing, defining, and managing requirements and discussions on the characteristics of "good" requirements (e.g., concise, necessary, attainable, verifiable, traceable, implementation free, evolvable).
January 08, 2020