Quality Assurance Director- Healthcare jobs in Indiana

Quality Assurance Director- Healthcare is responsible for overseeing the quality management and quality improvement programs for a healthcare facility. Directs quality assurance and compliance functions. Being a Quality Assurance Director- Healthcare ensures that policies and initiatives are efficient, meet patient expectations and are updated to reflect regulatory changes. Requires a bachelor's degree. Additionally, Quality Assurance Director- Healthcare requires a certification of registered nurse. Typically reports to a top management. The Quality Assurance Director- Healthcare 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 a Quality Assurance Director- Healthcare 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.

  • 21 Days Ago

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Director of Quality Assurance
  • Sharpen Technologies Inc.
  • Indianapolis, IN FULL_TIME
  • We are looking for a Quality Assurance (QA) Head who is a strong leader with experience in implementing and shaping the company’s QA processes and strategies, including transitioning to a full automat...
  • 4 Days Ago

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Quality Manage-RN
  • Assurance Health System
  • Indianapolis, IN FULL_TIME
  • Quality Manager- Full time **Must have an Associates or Bachelors of Nursing degree** Assurance Health is a short-term, inpatient geri-psychiatric facility that focuses on the mental health needs of o...
  • 19 Days Ago

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Quality Assurance Director (Government and Call Center Operations)
  • Maximus
  • Indianapolis, IN FULL_TIME
  • Job Description Summary This position will lead all quality operations for the Indiana Eligibility contract. Experience leading QA operations in a government call center and driving quality improvemen...
  • 24 Days Ago

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Director of Nursing
  • Assurance Health - Toledo
  • Indianapolis, IN FULL_TIME
  • Assurance Health System is a regional system of short-term, inpatient psychiatric hospitals with a focus on senior mental health care. Our dedicated staff provides highly specialized and compassionate...
  • 22 Days Ago

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Director of Quality and Compliance
  • NewVista Healthcare
  • Indianapolis, IN FULL_TIME
  • Who we areThe NewVista mission is to inspire hope and deliver holistic care to those in need of behavioral health services in a contemporary and healing environment – one that is conducive to providin...
  • 8 Days Ago

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Director of Quality Assurance
  • Skills Alliance
  • Fort Lauderdale, FL
  • I am working exclusively with a client looking to hire a Director QA to support their team. The successful candidate mus...
  • 3/29/2024 12:00:00 AM

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Quality Assurance Director
  • Conceal
  • Augusta, GA
  • Job Description Job Description As a Quality Assurance Director (QA Director), you will oversee the software quality con...
  • 3/29/2024 12:00:00 AM

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Director of Quality Assurance
  • McCallion Staffing Specialists
  • Montgomeryville, PA
  • Job Description Job Description Local manufacturing company is looking to hire a Director of Quality Assurance. This is ...
  • 3/29/2024 12:00:00 AM

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Quality Assurance Director (Nutraceuticals)
  • Gummi World
  • Chandler, AZ
  • Gummi World is a fast-growing nutraceutical manufacturer based in Chandler, Arizona. We strive to deliver the highest qu...
  • 3/28/2024 12:00:00 AM

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Director of Quality Assurance
  • Kelly Science, Engineering, Technology & Telecom
  • Kelly Scientific is supporting an Oklahoma based CDMO in their search for a skilled Director of Quality Assurance. Come ...
  • 3/27/2024 12:00:00 AM

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Director of Quality Assurance
  • Envision Unlimited
  • Chicago, IL
  • Job Description Job Description The Director of Quality Assurance is responsible for overseeing and implementing quality...
  • 3/26/2024 12:00:00 AM

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Director Of Quality Assurance
  • Executive Alliance
  • Cypress, CA
  • Job Description Job Description Our client is seeking a talented and driven Director of Quality Assurance to join our te...
  • 3/26/2024 12:00:00 AM

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Director of Quality Assurance
  • LHH
  • Elk Grove Village, IL
  • LHH is actively seeking a Director of Quality Assurance for a manufacturing company located in the Elk Grove Village are...
  • 3/25/2024 12:00:00 AM

Indiana /ˌɪndiˈænə/ (listen) is a U.S. state located in the Midwestern and Great Lakes regions of North America. Indiana is the 38th largest by area and the 17th most populous of the 50 United States. Its capital and largest city is Indianapolis. Indiana was admitted to the United States as the 19th U.S. state on December 11, 1816. Indiana borders Lake Michigan to the northwest, Michigan to the north, Ohio to the east, Kentucky to the south and southeast, and Illinois to the west. Before becoming a territory, various indigenous peoples and Native Americans inhabited Indiana for thousands of ye...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Director- Healthcare jobs
$127,617 to $182,125

Quality Assurance Director- Healthcare in Santa Barbara, CA
In healthcare institutions, quality assurance (QA) teams work throughout the system to design policies and procedures that promote the best possible patient outcomes.
December 20, 2019
Quality Assurance Director- Healthcare in Washington, DC
A strong quality assurance program is the key to meeting patient expectations and initiating changes that improve patient comfort, clinical outcomes and patient satisfaction levels.
December 10, 2019