Quality Assurance Manager

QUALIFICATIONS

• Minimum of a B.S. degree or equivalent in chemistry, biochemistry, or similar discipline required; Master’s degree in scientific discipline preferred.
• 5+ years in the Quality Assurance role working with internal GMP manufacturing or external GMP suppliers of drug substances, drug products, labeling and packaging, or a combination of the above. (Required)
• Preferred experience working with combination nasal spray products.
• Have at least 3-5 years of hands-on analytical chemistry in a GMP laboratory such as quality control or analytical development.
• Must be able to develop, lead, and motivate a team within a fast-paced manufacturing and design setting.
• Practical experience managing out of specification, out of trend investigations and analytical deviations including investigating manufacturing deviations.
• Excellent verbal and written communication skills
• Proven track record in leading multiple teams effectively.
• Excellent attention to detail and ability to multi-task.
• Proven success with implementation of quality system improvements.
• Strong understanding of 21 CFR 210 and 211, 21 CFR Part 11, and data integrity requirements, and applicable regulations.
• Knowledge of Operational Excellence, extremely intuitive with problem-solving and resolutions utilizing risk management tools.

ABOUT US:

Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns than those currently available for the treatment of anxiety, depression, and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH80, PH15, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug of an antagonist of the N-methyl-D aspartate receptor (NMDAR). Pherines are neuroactive nasal sprays designed with an innovative proposed mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic absorption or direct activity on neurons in the brain.
Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression, and several other CNS disorders.
At Vistagen, we emphasize that mental health is foundational to living vibrant and healthy lives. We believe that healthy minds create healthy communities, and our core goal at Vistagen is to radically improve mental health and well-being worldwide – One Mind at a Time. We are change-makers committed to improving lives by developing innovative, science-based mental health care medicines with the potential to make the impossible, possible - to empower and support patients and their caregivers to achieve faster-acting efficacy without the side effects and safety concerns associated with current treatment options for anxiety and depression.
Vistagen Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation.

ABOUT THE ROLE

Quality Assurance Manager will be a pivotal role in ensuring the highest standards of quality and compliance throughout the product development lifecycle. This position involves overseeing and implementing quality management systems, processes, and procedures to meet regulatory requirements and industry standards. The Quality Manager collaborates closely with cross-functional teams, including Chemistry, Manufacturing, and Controls (CMC), Regulatory Affairs, and Quality Assurance and Vistagen’s GMP suppliers, to drive continuous improvement initiatives and maintain a culture of quality excellence.
This will be a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the head of Quality Assurance.

ROLES & RESPONSIBILITIES

• Identify gaps and opportunities to develop further QMS, including writing and implementing SOPs and work instructions.
• Maintain electronic systems for training, document control, supplier audit schedule, and files.
• Review and approve GMP protocols for release and stability testing of Vistagen’s combination products, analytical method validation protocols and reports, master and executed batch records, product specifications, etc. Experience with analytical testing of combination nasal spray products is preferred.
• Contribute to out-of-trend and out-of-specification investigations and review executed investigations, ensuring that all documentation, including root causes analysis and applicable CAPAs, are well documented and archived for easy retrieval in Vistagen’s electronic file storage system.
• Collaborate with Vistagen’s GMP suppliers to investigate deviations, appropriate corrective and/or preventive actions, close out of supplier documentation, and completion of Vistagen’s internal forms for review and approval of deviations.
• Identify and Implement solutions in cooperation with other QA department personnel to improve quality and work efficiency.
• Scheduling of GMP supplier audits, authoring of audit agendas, the performance of remote or on-site audits of Vistagen’s GMP Suppliers, authoring of audit reports, issuance of audit observations, and completion of Vistagen forms to close out each audit.
• Participate in and coordinate remote or on-site audits of Vistagen by regulatory agencies. Reporting of regulatory audit findings to Vistagen Quality and corporate level management. Report all audit findings to upper management and respond to audit reports.
• Exercise Quality oversite of product-related complaints, ensuring that Vistagen is notified of issues within the reporting timelines stated in quality agreements. Responsible for ensuring a detailed investigation, identification of root cause(s), and complete documentation is obtained and reviewed.
• Develop, train and mentor staff by sharing knowledge, skills, and information with personnel in the Quality Assurance Department and across functional areas.
• Manage and execute site Quality System elements and processes such as CAPA, Deviations, OOS, Management of Change, ensuring that they are completed timely and properly documented.
• Provide site training and maintain a working knowledge of cGMP, ISO, and other relevant regulatory guidelines to act as a resource of information for site personnel.
• Ensure that Standard Operating Procedures are being followed.
• Perform and manage Company’s internal audit system.
• Manages processes and teams associated with control of nonconforming products, CAPAs, deviations, complaints, supplier management, post-market surveillance, audits, document control, acceptance activities, risk management and other Quality related activities.
• In partnership with the VP of Operations, establishes overall short and long-term quality strategy and objectives.
• Ensure operational Quality Assurance goals are aligned with department and company objectives.
• Interfaces with other departments and partners to ensure implementation of good compliance practices.
• Initiates and manages projects to continuously improve and increase efficiency of quality processes.
• Ensures compliance to site, corporate, and regulatory requirements as defined by applicable regulatory bodies and agencies.
• Establishes and manages training programs focused on cGMP, QMS, defect awareness, , and other training programs that promote quality awareness and understanding
• Monitors development of new or updates to existing regulations and accurately and effectively translates them into workable processes and procedures.
• Promotes the Culture of Quality throughout the organization.
• Works across sites to harmonize and/or align processes.
• Creates reports for and manages meetings covering Management Reviews.
• Manages projects and/or cross-functional teams as needed.
• Creates bench-marking opportunities to seek best practices with the intention of improving internal processes.
• Motivates and manages teams for high engagement and performance.