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.