About the Position
The ideal candidate has:
- a college degree in a related engineering or regulatory discipline (advanced degrees and/or certifications are a strong plus)
- at least ten years of relevant experience
- Experience in an FDA-regulated industry (preferably with over-the-counter drugs and/or medical devices)
- Supervisory experience with strong leadership skills and a collaborative nature
- Small- to mid-size companies, with ownership of the entire quality function
- FDA audits, especially as part of the response team
- Enforcement of quality standards
The Director of Quality reports directly to the CEO and is responsible for the development, implementation, and maintenance of quality assurance and quality control activities, and for overall facility compliance with current good manufacturing practices (cGMPs) and regulations.
Our interview process is rigorous, just as the job will be, to ensure both you and the team at Eosera have the chance to assess if this role will be a great match for your strengths. The salary range for this position is $125,000 - $135,000.
Eosera is a biotech startup company based in Fort Worth, Texas, specializing in developing ear care products and aspiring to a purpose of “healing humans”. Founded in 2015, Eosera is a majority woman-owned company and a supporter of conscious capitalism. Learn more at www.EARcareMD.com.
- Manage all aspects of the quality assurance, quality control and training programs
- Ensure that QA functions are compliant with all required cGMP regulations
- Accountable and responsible for the conducting of and supervision of cGMP audits, both internal, supplier and externally
- Oversee and have responsibility and accountability of the document control system including creation, revision, and approval of SOPs and batch records, as required.
- Direct the final goods, packaging stability program.
- Oversight of validation activities including writing, issuing, and reviewing protocols and reports
- Oversight of the change control system and related activities
- Oversight of complaint process
- Manage investigations for process deviations and product quality failures and implement corrective actions, and conduct corrections, as necessary
- Track and trend progress on all exception reports (including change controls, change reports, deviations, NCRs, CAPAs, etc) and all quality data, and report to President. If necessary, will report findings to ELT (Executive Leadership Team) as necessary and for periodic reviews
- Chair and conduct all quarterly Quality Review Meetings
- Oversight of calibration program
- Ensure establishment and maintenance of an effective training program to ensure quality assurance, quality control, and manufacturing personnel are adequately trained in cGMP's, regulations, and their job functions
- Maintain and improve the level of cGMP compliance, stay abreast and report out company-wide the industry and regulatory compliance trends and requirements.
- Ensure that all operations are performed in accordance to SOPs, FDA and cGMP guidelines and regulations
- Maintain effective communication with Management and relay critical issues and action plans involving the quality assurance areas
- Prepare monthly report to President on State of Facility and Procedures
- Serve as Quality Management Representative for the organization to internal and external stakeholders
- All other duties and responsibilities assigned
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required.
- Minimum BS or BA in natural sciences
- Master's degree (M. A.) preferred, or equivalent; or 10yrs years related experience and/or training; or equivalent combination of education and experience.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to professionally respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to professionally write responses, direction and technical quality and regulatory documents for publication that conform to prescribed style and format and withstand scrutiny from regulatory bodies and agencies, as well as technical review boards.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- To perform this job successfully, an individual shall or must have knowledge of and proficiency in Microsoft Office Business Suite.
Certificates and Licenses:
- Professional Regulatory certifications preferred: ASQ, RAPs, AAMI, ISO certs, etc.
- Minimum 10 years of experience
- Conducts supervisory responsibilities in accordance with the organization's policies and applicable laws
- Responsibilities include interviewing, hiring, and training employees
- Planning, assigning, and directing work
- Appraising performance
- Rewarding and disciplining employee
- Addressing complaints
- Resolving problems