Executive Director – Head of Quality
MapLight Therapeutics is an Equal Opportunity Employer offering a competitive salary and benefits package.
MapLight Therapeutics is a venture-backed clinical stage biotechnology company that focuses on drug development for central nervous system disorders. Our platform utilizes cutting-edge technologies including optogenetics and spatial transcriptomics to execute a circuit-based approach to target discovery. We are searching for a highly motivated Executive Director – Head of Quality. Reporting to the Chief Scientific Officer, the desired candidate will be responsible for defining and driving the Quality vision and mindset of the company in close collaboration with the executive leadership team. The candidate will develop and administer MapLight’s clinical quality strategy, global quality system, SOPs and training to ensure organizational compliance with regulatory requirements. The candidate should be prepared to prioritize and perform key day-to-day deliverables. While Maplight has in-house laboratories for pre-clinical research, all GXP activities are outsourced to external vendors. The position is remote with the ability to work from home when travel is not required. Office space is available for onsite work in Redwood City, CA and Burlington, MA if desired. This is a fantastic opportunity to join a small team and have a significant impact in addressing unmet patient needs by advancing MapLight’s novel pipeline.
Specific responsibilities include, but are not limited to:
- Drive execution of all aspects of Quality including clinical trial execution and manufacture of drug substance and drug products.
- Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions, and drive risk analysis and mitigation strategies.
- Implement the development, maintenance and management of quality systems that conform to applicable US and international regulatory requirements.
- Ensure appropriate systems are in place for follow up and closing investigations and audit observations.
- Ensure that exceptions are analyzed for corrective preventive actions and product impact.
- Provide leadership, guidance, and direction to MapLight personnel consistent with cGXP requirements.
- Conduct and/or manage internal and external audits to ensure compliance to relevant regulations, policies, and procedures.
- Evaluate facility, procedures, equipment, personnel and processes at CMOs, CROS, CDMOs, contract labs, and distributors to ensure consistent delivery of product that meets all applicable requirements.
- Interact with manufacturing, clinical, operations and other functional management as they impact the quality operation.
- Evaluate and sign off on compliance documentation including approving regulatory filings for designated products.
- Use considerable analytical and judgment skills to drive continuous improvements.
- 15+ years experience in the pharmaceutical biotech industry in combination with drug substance/drug product manufacture, development, quality, clinical, and/or regulatory
- 7+ years of Quality leadership experience, with a successful track record
- Experience with preclinical through Ph2 product development preferred
- Experience with part 11 and implementing electronic QMS preferred
- Understanding of worldwide requirements of cGXP and quality systems for clinical and commercial products
- Comfort dedicating significant time to day-to-day quality deliverables (document review, SOP authoring, audits, etc.)
- Ability to travel up to 15% of the time
- Bachelors or Advanced degree in a scientific discipline