Director of Quality Assurance

3 months 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.

  • Evestra, Inc. | Director of Quality Assurance

    5 days 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...

  • Food Safety and Quality Assurance Professional

    1 week ago

    Schertz, Texas, United States Magi Foods, LLC Full time

    Job Summary:We are seeking a skilled Food Safety and Quality Assurance Professional to join our MAGI Foods, LLC team. This role requires a strong understanding of food safety principles and the ability to implement them effectively in a fast-paced production environment.Key Responsibilities:Implement HACCP and BRC protocols to ensure food safety and...

  • Quality Assurance Professional

    2 weeks ago

    Schertz, Texas, United States Magi Foods, LLC Full time

    About UsMAGI Foods, LLC is a leading manufacturer of high-quality oatmeal products. We are committed to delivering safe and legal products that meet our customers' requirements.Job SummaryWe are seeking a motivated and detail-oriented QA Assistant to join our team. This role involves performing verification activities, training on food safety policies, and...

  • Director of Rehabilitation Services Lead

    5 days ago

    Schertz, Texas, United States Methodist Hospital Metropolitan Full time

    Methodist Hospital Metropolitan: A Leader in HealthcareWe are seeking a highly skilled Director of Rehab Services to join our team at Methodist Hospital Metropolitan. This is an exciting opportunity to lead a dynamic department and contribute to the delivery of high-quality patient care.Job SummaryThe Director of Rehab Services will be responsible for...

  • Project Director Construction

    2 weeks ago

    Schertz, Texas, United States Southland Industries Full time

    Job DescriptionWe are seeking a highly skilled Project Director to lead our construction projects and drive business growth.The successful candidate will have a strong background in project management, with excellent communication and leadership skills. They will be able to manage multiple projects simultaneously, prioritize tasks effectively, and maintain...

  • RN Independent Dispute Resolution Specialist

    2 weeks ago

    Schertz, Texas, United States Nexus Full time

    Nexus - RN Independent Dispute Resolution EntityEstimated Salary: $83,000 - $110,000 per yearJob DescriptionThe IDRE Nurse position at Nexus supports the Independent Review Organization (IRO) in completing review/determination and quality assurance efforts of independent dispute resolutions for both Federal and State level programs.Conduct...

  • Administrative Assistant

    1 month ago

    Schertz, United States City of Schertz Full time

    DEPARTMENT: Fleet & Facility ServicesPOSITION SUMMARY: Under general supervision, this position is responsible for preparing, coordinating and maintaining department reports, documents, letters, purchase orders, and all other related correspondence. Monitors office supplies and equipment repairs. Performs a wide variety of clerical and administrative duties....

  • Administrative Assistant

    3 weeks ago

    Schertz, United States City of Schertz Full time

    DEPARTMENT: Fleet & Facility ServicesPOSITION SUMMARY: Under general supervision, this position is responsible for preparing, coordinating and maintaining department reports, documents, letters, purchase orders, and all other related correspondence. Monitors office supplies and equipment repairs. Performs a wide variety of clerical and administrative duties....

  • Rehabilitation Services Manager

    5 days ago

    Schertz, Texas, United States Methodist Hospital Metropolitan Full time

    Take Your Career to the Next LevelMethodist Hospital Metropolitan invites applications for a Director of Rehab Services position. As a leader in rehabilitation services, you will have the opportunity to make a meaningful impact on the lives of our patients and their families.About the RoleThe Director of Rehab Services will be responsible for overseeing all...

  • Medical Director for Patient Care

    5 days ago

    Schertz, Texas, United States Optum Full time

    About UsAt OptumCare, we're committed to advancing healthcare through innovative approaches and technologies. As a clinician-led care organization, we empower our providers to deliver high-quality care while fostering a collaborative environment that values diversity and inclusion.Compensation PackageThis role comes with a competitive base salary of $250,000...

  • Marketing & Trade Show Coordinator

    2 months 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 months 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...

  • Medical Surgical Unit Director

    7 days ago

    Schertz, Texas, United States Methodist Hospital Stone Oak Full time

    Job DescriptionOur Nurse Manager of Medical Surgical Oncology position offers an exciting opportunity for a skilled nurse leader to join our dynamic team at Methodist Hospital Stone Oak.In this role, you will be responsible for overseeing the daily operations of our Medical Surgical Oncology unit, including staff management, quality improvement initiatives,...

  • Clinical Laboratory Scientist III

    2 months 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...

  • Senior Project Director

    2 weeks ago

    Schertz, Texas, United States Southland Industries Full time

    About the RoleWe are seeking a highly skilled Senior Project Manager to join our team at Southland Industries. As a Senior Project Manager, you will be responsible for providing overall management direction on complex mechanical or electrical projects and analyzing and developing new business opportunities relative to a particular client, group of clients,...

  • Clinical Laboratory Scientist II

    2 months 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

    3 months 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...

  • Mechanical Project Lead

    2 weeks ago

    Schertz, Texas, United States Southland Industries Full time

    Job OverviewThis is an exciting opportunity for an experienced Mechanical Project Lead to join our team and contribute to the success of our clients.The successful candidate will have a strong background in project management, with excellent communication and leadership skills. They will be able to manage multiple projects simultaneously, prioritize tasks...

  • Clinical Laboratory Scientist II

    4 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...

  • PreCertification Nurse Specialist

    4 weeks ago

    Schertz, Texas, United States Nexus Full time

    Job SummaryWe are seeking a skilled PreCertification Nurse Specialist to join our team at Nexus. As a key member of our Utilization Management department, you will play a critical role in ensuring the medical necessity and appropriateness of treatments for our clients.ResponsibilitiesAnalyze medical records for medical-legal reviews and create professional...