Jobs
>
Oklahoma City

    Compliance Director - Oklahoma City, United States - Thermo Fisher Scientific

    Thermo Fisher Scientific
    Thermo Fisher Scientific Oklahoma City, United States

    2 weeks ago

    Thermo Fisher Scientific background
    Description
    Job Description
    We are looking for a highly skilled pharma-GMP auditor and risk management leader.

    This leader will have a significant amount of quality auditing experience across diverse technologies, working with systems-based audit approaches that cover all aspects of pharma-GMP systems.

    We emulate a high degree of integrity, depth and accuracy in our approach, with a dedication to carrying out a premier audit program.

    What will you do?

    We identify systemic gaps in quality/compliance by conducting internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites.

    We prepare detailed audit reports to communicate observations written in a meaningful and accurate way, so that readers can easily understand the conditions or gaps in compliance with regulations and quality compliance standards.

    We maintain knowledge of GMPs, and are routinely aware of revised or emerging quality regulations and their trends, as well as industry methodologies across the globe.


    We promote positive Quality and leadership behaviors such as: creating environments for learning, harnessing lessons learned to drive continuous improvement; sharing standard methodologies; maintaining effective and open communication; and encouraging cross-functional partnerships.

    We also participate in ad-hoc quality compliance projects related to auditing (e.g. detailed trending reports, data analysis, reviewing global PSG policies, and preparing auditor training materials for
    internal/external quality auditors in the PSG network, etc.).

    How will you make impact?

    Becoming a key player in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit program.

    Helping to minimize risk across the sites and achieve successful regulatory inspections. Making a contribution toward the success of PSG and the services/products provided to clients and patients.

    How will you get here?
    Education
    Bachelor's Degree in Pharmacy, Science or Engineering required.
    Advanced degree in related field preferred.
    Experience

    Minimum of 15 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience with at least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections.

    Must be an expert Quality compliance auditor.

    Experience with elements of data integrity covering all areas in a pharmaceutical manufacturing environment, including production and QC laboratories, is also crucial, as well as being skilled in quality investigations, root cause analysis, audit reporting and benchmark sharing with a commitment towards quality improvement.

    Experience in sterile manufacturing and aseptic practice is desired.
    Professional auditor training/certification by an organization recognized within the pharmaceutical industry (e.g. IRCA, ASQ).
    Strong foundation of pharmaceutical manufacturing and laboratory operations.
    Diverse experience auditing a wide range of manufacturing technologies and services in 50% or more of the following areas:

    Sterile drug products:
    (liquid, lyophilized vials, prefilled syringes)

    Non-sterile drug products: (tablets, powders, capsules, granules, softgels)

    Biologics cell culture:
    upstream (Fed-Batch, Perfusion, XD, etc.) and downstream purification processes (Chromatography, nano filtration, etc.)

    Chemicals, intermediates, API manufacturing:
    (synthesis, purification, drying, isolation, etc.)

    Packaging operations:
    (primary and secondary)

    QC laboratories (Analytical and Microbiological)

    IT / Computer systems validation

    Clinical and commercial stage products and services

    Viral vector (VVS) and microbial manufacturing (MMS)

    Data integrity audits:
    (both laboratory and non-laboratory operations)


    Knowledge, Skills, Abilities:
    Strong communication skills including listening, judgment, problem management, ability to lead teams in a sophisticated and global environment.

    Ability to anticipate potential problems and risks related to quality system / regulatory expectations including ability to formulate and implement solutions.

    Strong collaboration and problem-solving skills; and adept at working well within a team environment.
    Capable to conduct remote auditing, when required.
    Strong oral/written communication skills appropriate for diverse international collaboration including excellent fluency in English.
    40-50% travel based on business needs.

    #J-18808-Ljbffr
  • Elevance Health

    Compliance Director

    3 weeks ago

    Elevance Health Oklahoma City, United States

    Compliance Director · Location: · This position will work a hybrid model (remote and office). The Ideal candidate will live within 50 miles of our Dallas, TX Elevance Health PulsePoint location. · The · Compliance Director · will be responsible for directing foundational and s ...

  • Tallgrass Energy Finance Corp.

    Director-Geoscience Compliance

    2 weeks ago

    Tallgrass Energy Finance Corp. Oklahoma City, United States

    Tallgrass was named one of the 2023 Top Workplaces USA and highlighted in Colorado's Top Workplaces for the past seven consecutive years. Tallgrass is a leading energy infrastructure company focused on safely, reliably, and sustainably delivering the energy and services that powe ...

  • Disc Medicine, Inc.

    Director of Quality Systems and Compliance

    1 week ago

    Disc Medicine, Inc. Oklahoma City, United States

    Director of Quality Systems and Compliance · Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovativ ...

  • Boston University

    ASSISTANT ATHLETIC DIRECTOR, COMPLIANCE, Athletics

    2 weeks ago

    Boston University Oklahoma City, United States

    Tracking Code · Job Description · The Assistant Athletic Director for Compliance oversees and coordinates a comprehensive compliance program that meets the NCAA, Patriot League and Hockey East Association legislation, policies and procedures. Manages and oversees all functions ...

  • Kinley Ames

    Child Care Substitute

    1 week ago

    Kinley Ames Oklahoma City, United States

    We are seeking highly motivated and experienced Child Care Director's to fill substitute assignments in Oklahoma. The Child Care Director will be responsible for the overall management, supervision, and operation of our clients' child care centers, ensuring a safe, nurturing, and ...

  • EasyCare Recruiting

    Automotive Assistant Finance Director

    5 days ago

    EasyCare Recruiting Oklahoma City, United States

    Automotive Assistant Finance Director · Kalidy Kia · We are currently seeking a qualified Automotive Finance & Insurance (F&I) professional to be a part of our amazing team. This is an incredible opportunity for an experienced individual who is excited by automotive F&I, with a s ...

  • INTEGRIS Health

    RN Stroke Coordinator

    1 day ago

    INTEGRIS Health Oklahoma City, United States TEMPORARY

    INTEGRIS Health Baptist Medical Center, Oklahoma's largest not-for-profit health system has a great opportunity for a RN Stroke Coordinator in Oklahoma City, OK. In this position, you'll work 7a-7p, Part-time weekends with our Stroke team providing exceptional care to those who h ...

  • Integris Health

    RN Circulator Supervisor

    11 hours ago

    Integris Health Oklahoma City, OK, United States

    INTEGRIS Health Baptist Medical Center, Oklahoma's largest not-for-profit health system has a great opportunity for an RN Circulator Supervisor in Oklahoma City, OK. In this position, you'll be a part of our Surgery Center team providing exceptional work supporting the INTEGRIS H ...

  • Integris Health

    RN Clin Education Consultant

    1 day ago

    Integris Health Oklahoma, United States Full time

    INTEGRIS Health, Oklahoma's largest not-for-profit health system has a great opportunity for a RN Clin Ed Consultant in Oklahoma City, OK. In this position, you'll work 8a-4p, Full-time, with our Nursing Education team providing exceptional care to those who have entrusted INTEGR ...

  • Integris Health

    RN Care Coordinator

    1 day ago

    Integris Health Oklahoma, United States Full time

    INTEGRIS Health, Oklahoma's largest not-for-profit health system has a great opportunity for a RN Care Coordinator in Oklahoma City, OK. In this position, you'll work Full-time with our Case Management team providing exceptional care to those who have entrusted INTEGRIS Health wi ...

  • INTEGRIS Health

    RN - Care Coordinator (Days)

    1 day ago

    INTEGRIS Health Oklahoma City, United States

    INTEGRIS Health, Oklahoma's largest not-for-profit health system has a great opportunity for a RN Care Coordinator in Oklahoma City, OK. In this position, you'll work 8a-5p, Full-time, with our Case Management team providing exceptional care to those who have entrusted INTEGRIS H ...

  • Integris Health

    RN Care Coordinator

    1 day ago

    Integris Health Oklahoma, United States Full time

    INTEGRIS Health, Oklahoma's largest not-for-profit health system has a great opportunity for a RN Care Coordinator in Oklahoma City, OK. In this position, you'll work 8a-5p, Full-time, with our Care Management team providing exceptional care to those who have entrusted INTEGRIS H ...

  • INTEGRIS Health

    Registered Nurse

    1 week ago

    INTEGRIS Health Oklahoma City, OK, United States

    INTEGRIS Health is seeking a Registered Nurse (RN) Manager for a nursing job in Oklahoma City, Oklahoma. · Job Description & Requirements · Specialty: Manager · Discipline: RN · Duration: Ongoing · Employment Type: Staff · The Director Quality and Safety is responsible for the de ...

  • INTEGRIS Health

    Supervisor Registered Nurse

    1 week ago

    INTEGRIS Health Oklahoma City, OK, United States

    INTEGRIS Health is seeking a Registered Nurse (RN) ED - Emergency Department Supervisor for a nursing job in Oklahoma City, Oklahoma. · Job Description & Requirements · Specialty: ED - Emergency Department · Discipline: RN · Duration: Ongoing · Employment Type: Staff · INTEGRIS H ...

  • Select Physical Therapy

    Physical Therapist

    2 weeks ago

    Select Physical Therapy Oklahoma City, OK, United States

    Overview: · Select Physical Therapy is seeking a full-time outpatient Physical Therapist (Ortho/Oncology) in Oklahoma City · At Select Physical Therapy, every physical therapist's journey becomes a testament to excellence, innovation, and life-changing patient care. Our outpatien ...

  • INTEGRIS Health

    Registered Nurse

    1 week ago

    INTEGRIS Health Oklahoma City, OK, United States

    INTEGRIS Health is seeking a Registered Nurse (RN) Quality Assurance for a nursing job in Oklahoma City, Oklahoma. · Job Description & Requirements · Specialty: Quality Assurance · Discipline: RN · Duration: Ongoing · Employment Type: Staff · INTEGRIS Health, Oklahoma's largest n ...

  • Rose State College

    Assistant Director, Nursing Science

    1 week ago

    Rose State College Midwest City, United States

    ACADEMIC AFFAIRS ANNOUNCES AN OPENING IN THE HEALTH SCIENCES DIVISION · POSITION: Assistant Director, Nursing Science · Description of Duties: Aid the Program Director in the proper functioning and evaluation of the program, support the Director with active involvement as a leade ...

  • Oklahoma State University

    Director of Admissions

    2 weeks ago

    Oklahoma State University Oklahoma City, United States

    Job Summary: · The Director of Admissionsserves as a key member of the student services leadership team and providesstrategic planning, direction, and supervision of the admissions team andenrollment management efforts. This position is responsible for coordinatingand assessing a ...

  • Landmark of Midwest City

    Assistant Director of Nursing

    2 weeks ago

    Landmark of Midwest City Midwest City, United States

    Landmark of Midwest City - WE ARE LOOKING FOR AN ASSISTANT DIRECTOR OF NURSING TO JOIN OUR TEAM · JOB SUMMARY: · Support the Director of Nursing in planning, developing, organizing, directing and evaluating services and activities of the Nursing Department. Work harmoniously with ...

  • Job Juncture

    Hospice Executive Director

    1 week ago

    Job Juncture Oklahoma City, United States

    EXECUTIVE DIRECTOR - HOSPICE · Lucrative compensation package to include Base + Bonus + equity · Hospice Executive Director needed for an established hospice provider doing a start-up in Oklahoma City, OK. Do you have the experience, drive & passion to do a start-up in your area. ...