The Director of Quality Assurance (DQA) will be responsible for leading the quality assurance and quality control (QA/QC) team and ensuring compliance with all applicable regulations and standards. The DQA is responsible for developing and implementing QA/QC strategies for new and existing products and is responsible for collaborating with Surgenex Regulatory Affairs team with maintaining relationships with regulatory agencies and ensuring that the QA/QC procedures and processes are current with all regulatory and standard changes. Provide the overall direction for consistency and training for those managed.
Lead, with quality assurance and quality control management, the development and implementation of strategies for new and existing products to meet the business needs of Surgenex.
Promotes QA/QC with the expectation of accurate records and data elements, and validation of all performance data.
Responsible for setting and executing short and long term goals and objectives.
Establish, implement, and maintain QA/QC systems and procedures to ensure compliance with all relevant regulatory and accrediting regulations and standards including the FDA, AATB and other state, federal, local, and international regulatory agencies.
Responsible for ensureing the use of the Quality Management System (QMS) for QA/QC processes.
In collaboration with the Sr. Director of Quality and Performance Excellence, develop metrics and reports with meaningful data related to activity levels, quality measures, and regulatory compliance to Surgenex leadership.
Perform complaint and nonconformance investigations, root cause analysis, and other problem solving activities to identify effective correction actions and process improvements.
Direct the review of records and approval of product and manufacturing quality assurance, controls and changes for adherence to Surgenex’s quality management system requirements.
Oversight for the donor chart quality control process ensuring compilation and review of all aspects of the charts is performed. Including and not limited to donor screening, medical records, serology, sterility and culture reports.
Ensure data integrity in all quality related documentation to meet regulatory compliance.
Responsible for management of the final product labeling processes to ensure compliance with Surgenex procedures, regulatory and accrediting agency requirements.
Responsible for facilitating communications with the Surgenex medical directors and providing to them, in a timely manner, records for review and final eligibility determination.Seek guidance from the medical director for medical related questions when applicable.
Maintain excellent judgement and decision-making capabilities to formulate quality solutions related to Surgenex’s mission.
Manages the selection, training, development, and performance of assigned staff to retain a motivated, professional workforce for the department.
Recruits and selects applicants for job vacancies considering the requirements of the job and the skills/abilities of the applicants.
Establishes and communicates job responsibilities as well as employee performance expectations to assure mutual understanding of desired results.
Identifies training and/or development opportunities that will assist the employee in achieving enhanced job performance and/or career objectives.
Constructively coaches and counsels for success to seek optimal employee performance.
Builds support and alliances between and among departments to promote Surgenex’s culture.
Conducts performance reviews in alignment with job expectations.
Performs other duties as assigned.
Accuracy - Ability to perform work accurately and thoroughly.
Analytical Skills - Ability to use thinking and reasoning to solve a problem.
Autonomy - Ability to work independently with minimal supervision.
Coaching and Development - Ability to provide guidance and feedback to help others strengthen specific knowledge/skill areas.
Ethical - Ability to demonstrate conduct conforming to a set of values and accepted standards.
Leadership - Ability to influence others to perform their jobs effectively and to be responsible for making decisions.
Management Skills - Ability to organize and direct oneself and effectively supervise others.
Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
Technical Aptitude - Ability to comprehend complex technical topics and specialized information.
Tolerance - Ability to work successfully with a variety of people without making judgments.
Accountability - Ability to accept responsibility and account for his/her actions.
Adaptability - Ability to adapt to change in the workplace.
Communication - Ability to communicate clearly and concisely.
Diversity Oriented - Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.
Judgment - The ability to formulate a sound decision using the available information.
Team Builder - Ability to convince a group of people to work toward a goal.
Compliance – Ability of the individual to be in accordance with established guidelines, policy, standards or regulations.
Education: Bachelor's Degree in healthcare field; Master’s Degree preferred; years of experience may be considered in lieu of education.
Experience: Four to six years related experience in tissue banking, biotechnology, pharmaceutical, or healthcare related field and in supervision or management of others. Working knowledge of relevant regulatory agencies.
Computer Skills: Knowledge of MS office programs
Certificates & Licenses: AATB CTBS and ASQ certifications required within 18 months of hire
Surgenex is a biotechnology company that specializes in the development and production of regenerative medicine products. They focus on using advanced technologies to harness the therapeutic potential of human tissue-derived materials.
Surgenex is known for its flagship product called Umbilical Cord Matrix (UCM) and Umbilical Cord Blood (UCB) products. These products are derived from donated umbilical cord tissue and blood collected during the birth of healthy, full-term babies. The company utilizes a proprietary processing method to obtain mesenchymal stem cells, growth factors, cytokines, and other biologically active components from these tissue sources.
The regenerative medicine products developed by Surgenex are used for various medical purposes, including wound healing, pain management, orthopedic applications, and tissue regeneration. They are often used in conjunction with other medical interventions to support the body's natural healing processes.