Director of Quality Assurance

1 month ago

schertz, United States Evestra, Inc. Full time

POSITION: Director, Quality Assurance


Are you ready for an exciting and challenging opportunity? An opportunity where you can make a lasting impact on a growing organization striving to change the face of women’s healthcare globally? Evestra, Inc. is a biopharmaceutical clinical stage company with a focus on developing and commercializing women’s healthcare products. Our mission is to improve the health and wellness of women using innovative technologies.

We seek an enthusiastic and experienced Head of Quality Assurance with a proven track record in quality assurance This is an extraordinary opportunity for the right candidate to help create a work model that delivers timely and accurate results while building and developing a team. The right candidate will have the chance to hone their skills and embark on a path to leadership.

We are conducting research and development in unmet medical needs areas such as endometriosis, fibroids, fertility control, HRT, and hormonal-dependent breast cancer by using its medicinal chemistry and drug delivery technologies. Evestra’s team has an extensive record in developing and commercializing biopharmaceuticals (for additional information please visit www.evestra.com).


Job Title: Director, Quality Assurance

Reports to: President and CEO


Critical Competencies and Qualifications: The successful candidate will have a bachelor’s degree or preferably higher and 7+ years QA experience plus at least 4+ years in relevant pharma companies, hands-on experience in pharmaceutical quality assurance including implementation of eQMS system.


Location: Schertz, TX


Compensation: Compensation commensurate with experience. Company provided relocation assistance will be offered.

Job Description:


The successful Candidate must:


  • Provide leadership in quality assurance to the entire company.
  • Ensure compliance in the company and work with the CEO to ensure all regulations are followed.
  • Develops, evaluates, and revises SOPs to ensure compliance with GMP/GLP/GCP regulations and guidelines.
  • Manages various QMS processes including Document & Records Control, NCR, Internal Audits, Supplier Management, Quality Certificates, Training, Customer Complaints, Analysis of Data, Design & Development, and CAPA.
  • Supports all aspects of Supplier Quality Management Program including supplier qualification audits/assessments, product quality assessments, ongoing supplier evaluation/audits/assessments, develop/approve Quality Agreements, and maintenance of the Approved Supplier List.
  • Provides quality leadership and guidance for equipment qualification, facility commissioning and qualification, manufacturing process validations and software validation.
  • Ensure that contracted suppliers comply with GMP/GLP/GCP regulatory requirements and relevant SOPs.
  • Provides QA review and approval of production batch records and testing results, specification changes, product non-conformances, deviations, and protocols/reports (e.g., validations, qualifications, capability, stability).
  • Executes Gap Analysis and/or Risk Assessments (HA, FMEA) to ensure evaluation of critical systems, processes and equipment are in-compliance with all regulatory requirements (e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO).
  • Leads, manages or participates in quality projects and teams for continuous improvement of internal quality system infrastructure and external manufacturing processes.
  • Represent the Quality Department during internal/external audits, FDA and other regulatory inspections.
  • Alerts line management of significant quality, compliance, supply and safety risks, often requiring the coordination of activity across organizational units. Exercises independent judgment.
  • Ensures completeness, accuracy and compliance of all documentation including CAPA management.
  • Performs and manages training of internal personnel to permit execution of required tasks and ensure compliance with regulatory requirements/policies/SOPs.
  • Develops and prepares quality data/metrics for Management Review.
  • Maintain up-to-date knowledge of cGMP regulatory issues, industry and affiliated publications, standards and guidance.


Qualifications:

  • Experience and track record in providing quality umbrellas for preclinical, clinical, and commercial manufacturing programs.
  • Very knowledgeable and up to date with FDA and EMA regulations.
  • Must be detailed oriented, possess excellent time management skills, be well organized, a self-starter and display a professional demeanor with a high focus on quality, compliance, and responsibilities.
  • Leadership skills with the ability to develop employees and maintain an atmosphere of growth and achievement; a self-starter with minimum oversight required to accomplish goals.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Must possess excellent communication and technical writing skills, strong interpersonal skills, and ability to work with others in a positive and collaborative manner; able to communicate with sense of urgency to internal and external customers.
  • Must be able to work as a team member, maintaining day-to-day activities while being able to be flexible and manage changing priorities.
  • Demonstrated experience with implementation/improvement of quality systems to ensure efficiency and effectiveness.
  • Experience with the development and implementation of current validation systems in the pharmaceutical industry.
  • Experience in developing and generating quality system metrics/trending.
  • Extensive knowledge of Root Cause Analysis / Risk Management / Good Manufacturing Practices / Quality System Regulations and ISO Standards is required.
  • Experience in auditing and FDA inspections.
  • Excellent writing, verbal and interpersonal communication skills.



The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts Management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


NOTE: Evestra does not sponsor foreign nationals for work in the US. Candidate must have prior authorization to work for any US company.

  • Director of Quality Assurance

    4 weeks ago

    Schertz, Texas, United States Evestra Inc. Full time

    Job Title:Director, Quality AssuranceReports to: President and CEOJob Summary:Evestra, Inc. is seeking an experienced Head of Quality Assurance to lead our quality assurance team. The successful candidate will have a bachelor's degree or higher and 7+ years QA experience plus at least 4+ years in relevant pharma companies, hands-on experience in...

  • Director of Rehabilitation Services

    3 weeks ago

    Schertz, Texas, United States Methodist Hospital Metropolitan Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Rehab Services to join our team at Methodist Hospital Metropolitan. As a key member of our leadership team, you will be responsible for overseeing all aspects of our rehabilitation services, ensuring that our patients receive the highest quality care.Key ResponsibilitiesDirect and...

  • Product Quality Specialist

    4 weeks ago

    Schertz, Texas, United States Greene Tweed Full time

    Job Summary: We are seeking a highly skilled Product Quality Specialist to join our team at Greene, Tweed. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards in our manufacturing processes.Key Responsibilities:Support first article inspection requirements, PPAP, and other product-related...

  • Executive Director

    4 weeks ago

    Schertz, United States YMCA of Greater San Antonio Full time

    The Executive Director directs the overall operations of the Schertz Family YMCA & Schertz Senior Center.This position is responsible for implementing the operations strategy to reach the annual strategic and fiscal objectives.The Executive Director works to position the Y as a community leader in the areas of Youth Development, Healthy Living, and Social...

  • Clinical Resource Director

    4 months ago

    Schertz, United States HealthTrust Supply Chain Full time

    Description This position is incentive eligible. IntroductionDo you want to join an organization that invests in you as a(an) Clinical Resource Director? At HealthTrust Supply Chain, you come first. HCA Healthcare has committed up to $300 million in programs to support our incredible team members over the course of three...

  • Administrative Director of Bone Marrow Transplant

    2 weeks ago

    Schertz, United States Methodist Hospital Full time

    Description This position is incentive eligible. Introduction Do you want to join an organization that invests in you as a(an) Administrative Director of Bone Marrow Transplant? At Methodist Hospital, you come first. HCA Healthcare has committed up to $300 million in programs to support our incredible team members over the course of three years. Benefits...

  • Emergency Department Nurse

    3 weeks ago

    Schertz, Texas, United States Schertz Cibolo Emergency Clinic Full time

    Job SummaryThe Staff Nurse is a licensed professional responsible for maintaining the standards of the Texas Board of Nurse Examiners. The RN will assess, organize, modify, evaluate, document and maintain the plan of care for Emergency Department patients. In performing his/her professional practice the RN is responsible for maintaining quality cost...

  • Night Shift Registered Nurse

    1 month ago

    Schertz, United States Schertz Cibolo Emergency Clinic Full time

    JOB DESCRIPTION: The Staff Nurse is a licensed professional responsible for maintaining the standards of the Texas Board of Nurse Examiners. The RN will assess, organize, modify, evaluate, document and maintain the plan of care for Emergency Department patients. In performing his/her professional practice the RN is responsible for maintaining quality cost...

  • Licensed Vocational Nurse

    3 weeks ago

    Schertz, Texas, United States Methodist Healthcare Ministries of South Texas Full time

    Job SummaryWe are seeking a skilled Licensed Vocational Nurse to join our team at Methodist Healthcare Ministries of South Texas. As a Licensed Vocational Nurse, you will play a vital role in providing high-quality patient care and supporting our healthcare team.Key ResponsibilitiesPerform clinical intake and document patient information accurately.Prepare...

  • Licensed Vocational Nurse

    2 months ago

    Schertz, United States Methodist Healthcare Ministries of South Texas Full time

    Essential Duties: Performs clinical intake utilizing appropriate terminology and abbreviations to determine patient's chief complaints and documents same. Prepares patients for exams, treatments, or procedures. Administers medications and treatments as directed by physician or provider. Provides education to patients and family regarding patient's condition...

  • Nuclear Medicine Technologist Opportunity

    3 weeks ago

    Schertz, Texas, United States South Texas Radiology Imaging Centers Full time

    We are seeking a highly skilled Nuclear Medicine Technologist to perform various procedures and maintain accurate documentation in accordance with regulations at South Texas Radiology Imaging Centers. In this role, you will be responsible for administering radiopharmaceuticals, adhering to safety protocols, and evaluating images for technical quality.Perform...

  • Speech Language Pathologist

    3 weeks ago

    Schertz, Texas, United States Methodist Hospital Full time

    About the RoleWe are seeking a skilled Speech Language Pathologist to join our team at Methodist Hospital. As a Speech Language Pathologist, you will provide high-quality patient care by developing and conducting individualized therapy programs for patients with communication, cognitive, and/or swallowing impairments.Key ResponsibilitiesConduct comprehensive...

  • Marketing & Trade Show Coordinator

    2 weeks ago

    Schertz, United States Boss Products, LLC Full time

    Marketing & Trade Show CoordinatorStatus: HourlyDate: 10/22/24Required Training: In House Reports To: Marketing & Communications ManagerDepartment: Product & MarketingPay Scale: $24.00 - $28.00 General Summary: The Marketing & Trade Show Coordinator role demands a blend of creative marketing acumen, meticulous organizational skills, and seamless execution...

  • Marketing & Trade Show Coordinator

    2 weeks ago

    schertz, United States Boss Products, LLC Full time

    Marketing & Trade Show CoordinatorStatus: HourlyDate: 10/22/24Required Training: In House Reports To: Marketing & Communications ManagerDepartment: Product & MarketingPay Scale: $24.00 - $28.00 General Summary: The Marketing & Trade Show Coordinator role demands a blend of creative marketing acumen, meticulous organizational skills, and seamless execution...

  • Clinical Laboratory Scientist III

    4 months ago

    Schertz, United States Methodist Hospital Landmark Full time

    Description Methodist Landmark Hospital Clinical Laboratory Scientist IIILaboratory DepartmentFull Time - Non-ExemptNight Shift -  Weekends Only!Do you have a passion for healthcare and helping others? Do you enjoy working in a fast-paced, patient-centered environment? Jump-start your career in our Laboratory Department. Submit your application...

  • Clinical Laboratory Scientist III

    2 days ago

    Schertz, United States Methodist Hospital Landmark Full time

    Description Methodist Landmark Hospital Clinical Laboratory Scientist IIILaboratory DepartmentFull Time - Non-ExemptDays Shift - Weekdays Only!Do you have a passion for healthcare and helping others? Do you enjoy working in a fast-paced, patient-centered environment? Jump-start your career in our Laboratory Department. Submit your application...

  • Clinical Laboratory Scientist II

    3 weeks ago

    Schertz, United States Methodist Hospital Full time

    Description Methodist HospitalClinical Laboratory Scientist IIBlood Bank DepartmentFull Time - Non-ExemptDay Shift - Rotating WeekendsDescriptionMust have strong Blood Bank BackgroundDo you have a passion for healthcare and helping others? Do you enjoy working in a fast-paced, patient-centered environment? Jump-start your career in our Blood Bank...

  • Clinical Laboratory Scientist III

    1 month ago

    Schertz, United States Methodist Hospital Stone Oak Full time

    Description Methodist Stone Oak Hospital Clinical Laboratory Scientist IIILaboratory DepartmentFull Time - Non-ExemptNight Shift - Rotating Weekends!Do you have a passion for healthcare and helping others? Do you enjoy working in a fast-paced, patient-centered environment? Jump-start your career in our Laboratory Department. Submit your application...

  • Nuclear Medicine Technologist

    4 weeks ago

    Schertz, Texas, United States South Texas Radiology Imaging Centers Full time

    Job Summary:We are seeking a skilled Nuclear Medicine Technologist to join our team at South Texas Radiology Imaging Centers. As a Nuclear Medicine Technologist, you will be responsible for performing nuclear medicine procedures and evaluating images for technical quality.Key Responsibilities:Administer radiopharmaceuticals to patients for diagnostic and...

  • Clinical Laboratory Scientist II

    2 months ago

    Schertz, United States Methodist Hospital Full time

    Description Methodist HospitalClinical Laboratory Scientist IIBlood Bank DepartmentFull Time - Non-ExemptEvening Shift - Rotating WeekendsDescriptionMust have strong Blood Bank BackgroundDo you have a passion for healthcare and helping others? Do you enjoy working in a fast-paced, patient-centered environment? Jump-start your career in our Blood Bank...