Jobs
>
Boise

    Director Quality Assurance Infectious Diseases/Vaccines - Boise, United States - Idaho State Job Bank

    Idaho State Job Bank background
    Description


    Director Quality Assurance Infectious Diseases/Vaccines at Merck in Boise, Idaho, United States Job Description Job Description Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies.

    We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

    The Quality Assurance Lead (QAL) will work independently, with limited guidance, to ensure implementation and management of the Quality Assurance strategy in a given Therapeutic Area (TA) across multiple programs, indications and/or regions.

    The QAL will ensure quality principles are considered throughout the drug development process, risk mitigation strategies for programs underway are implemented and quality metrics, including audits, are utilized to inform the business of the state of quality of the programs within their respective therapeutic area.

    The QAL will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of study participants.

    This role will be responsible to perform risk assessments to identify audit targets, conduct audits, develop and maintain audit tools, as well as, review audit reports.

    They will work to assure quality standards are consistently applied and will escalate resource and data quality matters to Senior Management as appropriate.


    Primary Responsibilities:

    Primary activities include, but are not limited to: + Represents Quality Assurance (QA) as the single point of contact for programs in a certain TA or across TAs in a certain region and provides QA strategic guidance.

    + Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions and status of competitor/similar products/projects to effectively develop and advance QA strategies.

    + Maintains robust audit and quality oversight plans for aligned TA, contributes to the QA strategy and through collaboration with stakeholders and our Research & Development Division's QA TA Heads, refines and adjusts strategies and plans as needed.

    + Identifies areas of greatest risk, through intelligence gathering (e.g., data trends, identified quality issues, regulatory intelligence), to proactively and accurately address and complete risk based QA assessments and influence the implementation of robust mitigation strategies.

    + Lead and manage a range of GCP and/or Good Pharmacovigilance Practice (GPVP) audits, including complex audits (i.e., directed, for-cause), for a given program, across a program, therapeutic area or region.

    + Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate, to provide Good Clinical Practice, Pharmacovigilance and QA expertise.

    + Actively participate in Significant Quality Issue management, including assessment of potential root causes and remediation (corrective and preventative actions).

    + Develops and enhances QA procedures, guidance documents and audit tools to ensure consistent global QA practices.

    + Ensures rapid communication of QA issues including potential misconduct or issues of significant deviation within project/products to appropriate leaders and colleagues.

    + Provides inspection management support as needed.

    + Manage personnel or assist with the management of personnel and planning functional group activities to achieve functional area and/or departmental objectives, as applicable.

    + Provides guidance and collaborates with QA Specialists, as appropriate, to assure adequate audit focus and timely knowledge transfer. + Provides training and mentorship to less experienced members of our Research & Development Division's QA.


    Education Minimum Requirements:
    + A Bachelor's degree in a related field with a minimum of 8-10 years of experience in GCP Quality/Auditing focused role. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy
    • Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
    If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

    Current Employees apply HERE (Current Contingent Workers apply HERE (US and Puerto Rico Residents Only:

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

    Please click here ( if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.

    All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

    For more information about personal rights under the U.S.


    Equal Opportunity Employment laws, visit:

    EEOC Know Your Rights (EEOC GINA Supplement? Pay Transparency Nondiscrimination ) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

    The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total d To view full details and how to apply, please login or create a Job Seeker account


  • Trinity Health Boise, United States Full time

    Saint Alphonsus Medical Group (SAMG) is a physician led and accountable 600+ provider multispecialty group practice seeking an Infectious Disease Physician. · Come and join our brand-new Infectious Disease team based in Boise, Idaho. Its a team consisting of 4.0 FTE physicians wo ...


  • Enterprise Medical Recruiting Idaho, United States

    A hospital-owned multi-specialty group in Coeur d'Alene, Idaho, is seeking an additional Infectious Disease physician. The area has grown exponentially, and patient volumes have rapidly increased. · Opportunity Details · Practice a mix of inpatient and outpatient with flexible ...


  • Saint Alphonsus Boise, ID, United States Full time

    Saint Alphonsus Medical Group (SAMG) is a physician led and accountable 600+ provider multispecialty group practice seeking an Infectious Disease Physician (MD/DO) to work full-time, doing a mix of inpatient and outpatient work on the Saint Alphonsus Regional Medical Center Campu ...


  • St. Luke's Health System Boise, United States

    **Overview** · St. Luke's Clinic: Infectious Disease seeks a BC/BE Infectious Disease physician to join our phenomenal team of extensively trained and highly dedicated providers comprised of five physicians and three APP's, with the upcoming recruitment of an ID pharmacist to sho ...


  • St. Luke's Health System Boise, United States

    Overview · St. Luke's Clinic: Infectious Disease seeks a BC/BE Infectious Disease physician to join our phenomenal team of extensively trained and highly dedicated providers comprised of five physicians and three APP's, with the upcoming recruitment of an ID pharmacist to shortly ...


  • St. Luke's Health System Boise, United States

    St. Luke's Clinic: Infectious Disease seeks a BC/BE Infectious Disease physician to join our phenomenal team of extensively trained and highly dedicated providers comprised of five physicians and three APP's, with the upcoming recruitment of an ID pharmacist to shortly follow. Th ...


  • Trinity Health Boise, United States Full time

    Saint Alphonsus Medical Group (SAMG) is a physician led and accountable 600+ provider multispecialty group practice seeking an Infectious Disease Physician (MD/DO) to join our brand-new Infectious Disease team based in Boise, Idaho. · Its a team consisting of 4.0 FTE physicians w ...


  • The Curare Group Boise, United States

    Our client near Boise, Idaho is seeking a Board Eligible/Board Certified Infectious Disease physician that has completed a fellowship for their current opening. This position is with an existing Infectious Disease group and it is a hybrid of inpatient/outpatient work. In addition ...


  • St. Luke's Health System Boise, United States Full time

    St. Luke's Clinic: Infectious Disease seeks a BC/BE Infectious Disease physician to join our phenomenal team of extensively trained and highly dedicated providers comprised of five physicians and three APP's, with the upcoming recruitment of an ID pharmacist to shortly follow. Th ...


  • St. Luke's Health System Boise, United States Full time

    St. Luke's Health System in Boise, Idaho is seeking an Infectious Disease Clinical Pharmacy Specialist – Outpatient Antimicrobial TherapyThis clinic pharmacist will be implementing a new practice as an outpatient parenteral antimicrobial therapy (OPAT) pharmacist in collaboration ...


  • Trinity Health Corporation Boise, ID, United States Full time

    Employment Type: · Full time · Shift: · Description: · Location: Boise · Status: Full Time, Employed · Schedule: Weekdays · Call: None · Salary and Benefits: · * Relocation · * PTO & CME Allocation · * Malpractice Insurance (Incl. Tail) · * Health/Dental/Vision · * Retirement (40 ...


  • Saint Alphonsus Boise, United States

    Saint Alphonsus Medical Group (SAMG) is a physician led and accountable 600+ provider multispecialty group practice seeking an Infectious Disease Physician (MD/DO) to work full-time, doing a mix of inpatient and outpatient work on the Saint Alphonsus Regional Medical Center Campu ...


  • Physician Empire Idaho, United States

    Southeastern Idaho · Grand Teton area · 80 miles to Jackson Hole & Grand Teton National Park · 150 miles to Twin Falls · 180 miles to Ogden, UT · FM & IM Residency Programs · Infectious Disease candidate to join a multi-specialty medical group. As the gateway to Yellowstone ...


  • Vibra Healthcare Boise, United States PER_DIEM

    Overview · COME BUILD YOUR CAREER WITH VIBRA HEALTHCARE · We are seeking a Occupational Therapist to join our team · Hospital Details · Vibra Hospital of Boise, located in Boise, ID, is a 40 bed Critical Care Hospital, providing acute care services to patients recovering from ...


  • ANESTHESIA ASSOCIATES OF BOISE Boise, United States

    We have a fantastic job opportunity for a board-certified/eligible generalist willing to do pediatrics cases as well as adults in the vibrant capital city of Boise, Idaho. · We are a group of 34 total anesthesiologists and 127 CRNAs (system-wide care team model), with six cardiac ...


  • Vibra Healthcare Boise, United States Full time

    Overview · COME BUILD YOUR CAREER WITH VIBRA HEALTHCARE · We are seeking a Nurse Practitioner to join our team · 7 Days on 7 Days off · Hospital Details · Vibra Hospital of Boise, located in Boise, ID, is a 40 bed Critical Care Hospital, providing acute care services to pat ...


  • Idaho State Job Bank Boise, United States

    Clinical Research Manager - Infectious Disease/Vaccine (REMOTE) at Merck in Boise, Idaho, United States Job Description Job Description Position Description: Clinical Research Manager - Infectious Disease/Vaccine (REMOTE) This role is primarily accountable for the end-to-end perf ...

  • Idaho State Job Bank

    Food Service Worker

    5 days ago


    Idaho State Job Bank Boise, United States

    Food Service Worker at Veterans Canteen Service in Boise, Idaho, United States Job Description Starting Hourly Wage $ 16.85 The Veterans Canteen Service (VCS) located at the Boise, ID, VA Medical Center is seeking part-time Food Service Workers to provide quality service to our n ...


  • Idaho State Job Bank Boise, United States

    Lead Site Contract Manager, North America Site Contracting, Oncology at J&J Family of Companies in Boise, Idaho, United States Job Description Lead Site Contract Manager, North America Site Contracting, Oncology W Description Janssen Research & Development, L.L.C., a division of ...

  • St. Luke's Health System

    Registered Nurse

    1 week ago


    St. Luke's Health System Boise, ID, United States

    St. Luke's Health System is seeking a Registered Nurse (RN) Manager, Clinic for a nursing job in Boise, Idaho. · Job Description & Requirements · Specialty: Clinic · Discipline: RN · Duration: Ongoing · 36 hours per week · Shift: 12 hours · Employment Type: Staff · Overview · At ...