Senior Director, Quality Assurance

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What You’ll Do: The Senior Director, Quality Assurance serves as an additional QA in-house subject matter expert on GxP compliance and  also serves as the senior quality leader to ensure full alignment between customers (other MapLight internal departments), vendors and consultants on all quality and compliance topics.

Responsibilities: 

• Partner with the VP QA to develop and implement comprehensive Quality Assurance strategies to support the manufacturing, testing, and release of pharmaceutical products in accordance with GxP regulations and other relevant standards. Designs and implements policies, and practices to ensure Quality Assurance and GxP compliance, and lead a quality culture within the organization. Ensures the quality organizational processes conform with standard operating procedures. Contributes to the strategy and approach for all inspection/ audits in compliance with local and global regulatory agencies. Performs lot release activities across all products.
• Support all aspects of the Quality Management System (QMS) to ensure compliance with GMP, GLP, GCP, and other applicable GxP guidelines.
• Collaborate with cross-functional teams, including Research and Development, Discovery, Regulatory Affairs, Manufacturing, Clinical Operations, and Supply Chain, to ensure seamless integration of quality processes throughout the product life cycle in alignment with GxP requirements.
• Conduct risk assessments and implement proactive measures to prevent and address quality issues, deviations, and non-conformances within the GxP context.
• Support regulatory inspections, ensuring readiness and effective responses to inspection findings, with a focus on GxP compliance.
• Establish and maintain key performance indicators (KPIs) to monitor and report on the effectiveness of the Quality Assurance program within the GxP framework.
• Drive the development and execution of training programs to enhance the skills and knowledge of quality personnel and other relevant stakeholders, with emphasis on GxP principles.
• Drive continuous improvement initiatives across the organization to increase compliance and / or productivity.
• Supports IND and NDA CMC module authoring, review and QC, supports responses to requests for information from regulatory agencies; supports the creation of reports and documentation needed for regulators and actively scans quality landscape to ensure alignment and identify laws and regulations that impact the company’s policies.
• Collaborate on appropriate change and communication approach as needed, manage changes in systems or procedures when necessary, and provide GxP Quality Assurance oversight of vendors, requalification and quality agreements.
• Responsible for supporting Quality Operations in Batch record review, OOS, deviations, change controls and product complaint investigations and GxP archives. Support continuous improvement of the quality system to ensure product reliability, quality, efficacy, and compliance. Oversees compliance auditing program to fulfill regulatory requirements.
• Follow applicable regulations, including FDA, ICH, and applicable Regulatory / Health Authorities.
• Support commercialization initiatives including implementation of Drug Supply Chain Security Act (DSCSA) serialization, develop commercial stage SOPs and Policies, and regulatory submissions.

Qualifications:

• Advanced degree strongly preferred.
• 15 years of progressive leadership in Quality within a biotechnology company.
• Deep expertise in ICH, FDA, and EMA guidelines.
• Strong track record of managing audits. 

Location: This is a hybrid role with three days per week onsite in either our Burlington, MA or Redwood City, CA offices. Please refer to the city listed on the top of this post for this role's location. 

MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.