Clinical Quality (GCP) Leader - VistaGen Therapeutics

ABOUT THE ROLE

We are seeking a highly motivated and experienced Clinical Quality GCP Leader to join our team. The successful candidate will play a key role in ensuring compliance with Good Clinical Practice (GCP) standards across all clinical trials and programs.

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

• This role is accountable for the routine execution of Quality Assurance & Compliance duties related to the Company’s clinical development programs, as well as overseeing the development, implementation, maintenance, and performance of the GCP Quality Assurance systems both within the company and external vendors.
• Act as an integral member of the Quality Management team and work cross-functionally with Clinical and other teams.
• Formulate and execute strategies and roadmaps with the company’s Quality vision.
• Collaborate closely with the clinical study management team and the Quality team to provide expert clinical compliance information, address identified issues, and drive continuous improvement.
• Maintain up-to-date knowledge of relevant regulatory requirements.
• Develop interpretation and application of existing and new requirements in conjunction with relevant stakeholders.
• Design, implement, monitor, and maintain the Quality Management System for GCP
• Leads intra/inter-departmental teams and/or projects aimed at enhancing the GCP Quality Management System through fostering positive change.
• Author and/or approval of GCP procedures.
• Review clinical trial documentation and collaboratively work to resolve internal and external compliance issues.
• Conducts internal audits of Clinical CGP processes for adherence to SOPs, company policies, and regulations/standards.
• Assist in identifying, reporting, and developing Corrective and Preventive Actions (CAPA) for deviations, in close collaboration with the clinical study team and clinical sites.
• Ensure qualification of and maintain oversight over contracts auditors and Contract Research Organizations (CROs), ensure that CROs appropriately qualify clinical sites, and monitor their performance. 
• Spearhead the development of audit strategy plan(s) and ensuring timely execution of plans for programs.
• Develops and performs or coordinates the execution of training in GCPs to internal clinical teams. 
• Oversees GCP routine and complex audits, develops and execute Vistagen-specific training clinical site readiness for regulatory inspections.
• Provide support during and following health authority inspections.
• Ensure training plans are in place in collaboration with functional line managers
• Provide effective compliance reporting to senior management and relevant governance forums.
• Assume a leadership role in managing regulatory inspection activities such as readiness preparation, inspection management, and/or response management.
• Offer support regulatory agency inspections and internal and external audits, as needed.
• Cultivate a commitment to quality within individuals and foster a culture of quality within the Company.
• Fulfill other duties as assigned.

QUALIFICATIONS

• Bachelor’s Degree and 12+ years’ experience leading clinical quality assurance OR Master’s Degree or PhD and 10+ years’ leading quality assurance for a pharmaceutical or biotech company. (Required)
• Previous experience working in clinical operations is preferred. 
• Proficiency in and ability to apply GCP in accordance with US standards.
• Extensive expertise in GCP regulations, quality systems, and regulatory requirements
• Hands-on clinical quality experience in dosage forms designed to target the central nervous system.
• Self-driven, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description.
• Acknowledged as an authority in the realm of Clinical QA and Compliance field.
• Adept at effective negotiation and fostering collaboration among diverse individuals.
• Willingness to innovate and adapt best practices to suit the specific needs of the product.
• Capable of managing multiple projects simultaneously, showcasing organizational prioritization and time management skills.
• Comfortable in a dynamic small company setting, able to work independently, and flexible in responding to changing priorities.

What we offer:

• Industry competitive compensation
• Performance-base bonuses
• Stock options
• Employee Stock Purchase Plan
• 401K plan
• A collaborative and innovative work environment at the forefront of biotech advancements.

Give your best, live wholesomely:

• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HAS
• Basic Life Insurance 2x Earnings & AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare system

Work-Life Balance:

• Unlimited paid time off
• Flexible work schedule
• Remote work option
• Paid Holidays
• Mental Health Days & Observances
• Winter shut-down
• Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

The anticipated salary range for candidates who will work remotely is $160,000 to $200,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification, as well as a general description of benefits and other compensation. They are not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand, walk, use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally. Evening and weekend work as necessary.

Role requires 10-15% travel.

Disclaimer

This is intended to provide a general description of the job responsibilities, benefits, and other compensation and is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

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.