IT Quality Assurance Director jobs in Anderson, IN

IT Quality Assurance Director is responsible for planning and directing the policies, programs, and initiatives used to monitor and measure the overall quality of IT services, systems, and software. Ensures that tracking systems capture useful operational metrics for use in reducing defects, improving service, and optimizing the implementation process. Being an IT Quality Assurance Director requires a bachelor's degree. Typically reports to a top management. The IT Quality Assurance 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 IT Quality Assurance 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 Assurance
  • 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 – Quality Assurance, reporting to the Sr Director of QA/QC, is responsible for managing the activities of Quality Assurance personnel.

    The Associate Director Quality Assurance must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations.

    The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.

    The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.

    Objectives

    Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, 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 technical agenda, site business plan objectives, and GMP Quality Plan objectives

    Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits

    Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.

    Ensure adequate oversight and technical excellence for investigations and complaints.

    Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality

    Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.

    Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.

    Potential to engage and influence Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.

    Escalate issues to management.

    Accountabilities

    Batch record review (Executed and Master) for all stages of manufacturing

    Promote a positive Quality Culture and oversee on-the-floor Quality presence in the respective business area (e.g., manufacturing).

    Provide Quality direction for complex business and operational issues or technical challenges. Remove barriers as they arise.

    Final disposition of finished product for commercial and clinical use, including country-specific release and collaboration with Qualified Persons (QPs)

    Authoring and review of deviations, CAPAs, and change controls

    Investigation of product complaints

    Quality review of analytical documentation including: analytical methods; validation protocols and reports; specifications; and stability protocols, reports, and expiry extensions

    Oversee and monitor Quality metrics. Ensure data compiled are communicated in relevant forums and escalate compliance issues/concerns to Quality senior management.

    Review and approval of commercial and clinical product labels

    Authoring/ revision of SOPs

    Leading process improvements

    Ensuring that GMP work at POINT and contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.

    Participation on project teams and sub-teams as needed and assigned

    Compose and review SOPs, protocols, reports, forms, and certificates of analysis.

    Interact with auditors and regulatory inspectors.

    Collaborate with other departments on projects, including inter-site and inter-company.

    Mentor and develop direct reports.

    Requirements

    Education and Experience:

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

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

    Proven track record of investigation (RCA) and CAPA implementation for the improvement of lab operations.

    A minimum of 2 years of management/leadership experience is required.

    Availability to support the testing activities of time-sensitive radiopharmaceuticals.

    Critical Competencies:

    Excellent oral and written communication skills

    Demonstrated ability to function well in a collaborative team environment.

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

    Operate and execute with an extreme sense of urgency.

    Excellent organizational and interpersonal skills

    Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)

    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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Quality Assurance Specialist
  • Cook Group
  • Kokomo, IN FULL_TIME
  • Overview The Quality Assurance Specialist is responsible to:1. Maintain and ensure effectiveness of the Quality Management System in Singapore and Malaysia,2. Perform product complaints handling for S...
  • 11 Days Ago

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Quality assurance specialist
  • Curium
  • Noblesville, IN FULL_TIME
  • About Curium Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to ...
  • 11 Days Ago

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Quality Assurance Specialist
  • Curium Pharma
  • Noblesville, IN FULL_TIME
  • Quality Assurance Specialist Date: Jan 4, 2024 Location: Noblesville, IN, United States About Curium Curium is the world's largest nuclear medicine company with more than a century of industry experie...
  • 13 Days Ago

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Quality Assurance Coordinator
  • Youth Opportunity Center
  • Muncie, IN FULL_TIME
  • Quality Assurance CoordinatorFLSA Status: Full-Time Exempt Division: YOC Quality Assurance Reports To: Director of Quality Assurance COMPANY OVERVIEWMore than a beautiful 75 acre campus, and beyond an...
  • 14 Days Ago

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Quality Assurance Tech
  • Park 100 Foods, Inc.
  • Kokomo, IN FULL_TIME
  • Come work for the #1 Custom Craft Kettle company on the country! We are hiring for food production Quality Assurance Technicians Kokomo, IN 3rd shift (11:30pm-8am) Competitive Pay and benefits package...
  • 1 Day Ago

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0 IT Quality Assurance Director jobs found in Anderson, IN area

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Family Medicine Physician - Anderson, IN
  • JSC
  • Anderson, IN
  • Job Description Job Description General Summary of Duties: Provides primary care to patients acting as a physician in th...
  • 3/18/2024 12:00:00 AM

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Director of Quality
  • The Judge Group
  • Indianapolis, IN
  • Description:As Quality Assurance Director, you will be responsible for overseeing all aspects of Quality Assurance and S...
  • 3/18/2024 12:00:00 AM

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Family Medicine Physician and IM/Primary Care Physician - Muncie, IN
  • JSC
  • Muncie, IN
  • Job Description Job Description General Summary of Duties: Provides primary care to patients acting as a physician in th...
  • 3/18/2024 12:00:00 AM

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Clinical Manager Home Health Full Time
  • CenterWell Home Health
  • Muncie, IN
  • Become a part of our caring community and help us put health first Develops, plans, implements, analyzes, and organizes ...
  • 3/17/2024 12:00:00 AM

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Restaurant Supervisor
  • McDonald's
  • Noblesville, IN
  • Description As a Supervisor, you will be responsible for overseeing and developing 4-6 restaurants and their General Man...
  • 3/17/2024 12:00:00 AM

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MT/MLT/Laboratory Scientist: 40 Hours Per Week (PM)
  • Alverno Laboratories
  • Carmel, IN
  • Description Franciscan Health Indianapolis Location: 8111 S. Emerson Ave., Indianapolis, IN 46237 AND Franciscan Health ...
  • 3/15/2024 12:00:00 AM

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Project Manager - Utility Infrastructure- Indianapolis
  • American Structurepoint
  • Indianapolis, IN
  • Overview: When you join American Structurepoint, you gain more than a career. You become part of a family of talented, p...
  • 3/14/2024 12:00:00 AM

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Caregiver Residential Manager FT
  • Caregiver, Inc.
  • Anderson, IN
  • The Residential Manager (RM) is primarily responsible for ensuring that services are provided as required by the Individ...
  • 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 IT Quality Assurance Director jobs
$180,159 to $252,176
Anderson, Indiana area prices
were up 1.3% from a year ago

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A quality assurance role should be established for all projects.
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