San Diego, CA
Director or Senior Director, Quality Assurance
General Job Description:
Neurelis is a neuroscience-based specialty pharmaceutical company providing innovative approaches to target unmet medical needs. Our approach combines novel technologies designed to enhance therapeutic benefit and address unmet needs in patient care. Neurelis offers competitive pay and benefits and a collaborative and growing team who are passionate about their products and company. We may be small but we are mighty! Reporting to the Senior Vice President, Regulatory Affairs and Quality Assurance, the Director or Senior Director, Quality Assurance will be responsible for leading the strategy, implementation, and leadership of the Quality Assurance function at Neurelis. This includes leading the execution and administration of the GxP quality systems to support GMP, GLP, GCP, GPvP and GDP compliance in accordance with US, ICH and EU regulations. The Director or Senior Director, Quality Assurance will establish quality systems, create, administer and manage SOPs, and oversee field-based consultants.
Ensures quality and compliance oversight for manufacturing, supply chain and distribution, nonclinical, clinical and IT systems that support the developmental programs and commercial portfolio of Neurelis.
Manages compliance to and of the Neurelis quality systems.
Provides quality oversight of external vendors (CMOs, CROs, suppliers, etc.) and ensures adherence to Neurelis' vendor qualification criteria.
Establishes an annual audit plan and conducts external audits of vendors.
Responsible for managing the product complaints process, including handling escalated complaints, conducting investigations, and managing records.
Participates in batch record review and approval, and ensures that copies of all manufacturing batch records are archived.
Establishes product verification and suspicious order monitoring programs.
Ability to work with and influence others in a multi-disciplinary environment.
Provide leadership as well hands-on support in managing, planning, coordinating, preparing and reviewing documents that will be part of the Neurelis quality system.
Ability to manage indirect reports, including field-based consultants and vendors.
Excellent interpersonal and communication skills.
Agile mindset, ability to embrace change, and able to lead successfully during environmental and/ or objective ambiguity.
Willing and able to contribute in a hands-on manner.
Ability to travel up to 20% (within COVID-19 guidelines).
Minimum BS degree (MS degree is preferred) in relevant chemistry or life science discipline.
Minimum of 10 years of experience in quality functions, with a history of increasing responsibility.
Experience with EDMS for quality systems.
Extensive experience in managing GMP activities, preparing for and leading regulatory inspections.
Experience working in a small company environment is preferred.
Working knowledge of Veeva Vault systems is preferred
All recruiting, hiring, training, promotion, compensation, and other employment-related programs at Neurelis are provided fairly to all persons on an equal opportunity basis without regard to race, creed, color, religion, sex, age, national origin, disability, veteran status, or any other characteristic protected by law; Employment decisions are based on the principles of equal opportunity and affirmative action; and All personnel actions such as compensation, benefits, transfers and training are administered without regard to race, creed, color, sex, age, national origin, disability, veteran status, or any other characteristic protected by law. Neurelis is an Equal Opportunity Employer.
Application Information & Contact (How to Apply)
Please email resume/ CV to email@example.com
Learn more about Neurelis here.