Quality Systems Specialist
The Quality Systems Specialist at MapLight Therapeutics plays a pivotal role in supporting the development and manufacturing of the company's products. Reporting to the Senior Manager of Quality Systems within the Quality Assurance department, this position is integral to maintaining and enhancing the Good Manufacturing Practice (GMP) Quality Management System, ensuring compliance with applicable GxP regulations, company policies, and standard operating procedures.
Key responsibilities include managing the full lifecycle of controlled documents within the electronic Quality Management System (ZenQMS), ensuring accuracy and compliance with regulatory and internal requirements. The specialist will collaborate with internal stakeholders to align documentation processes, provide support on document control and quality system procedures, and assist in the creation and revision of Standard Operating Procedures (SOPs) and Work Instructions (WIs). Additionally, the role involves supporting the onboarding of new employees and managing quality system processes such as deviations, Corrective and Preventive Actions (CAPAs), and change controls.
Candidates should possess a bachelor's degree in a scientific discipline or equivalent work experience, with a minimum of five years in the biotechnology or pharmaceutical industry. A solid understanding of FDA, EMA, and ICH guidelines and regulations, along with familiarity with GCP, GMP, and GLP standards, is essential. The role requires excellent attention to detail, organizational and communication skills, and proficiency in Microsoft Office Suite. Experience with electronic quality management systems (eQMS) is strongly preferred.
This hybrid position requires three days per week onsite at the company's office in Burlington, MA. Compensation includes an annual salary ranging from $100,000 to $125,000, with additional benefits such as an annual bonus opportunity, medical, dental, vision, life and AD&D insurance, short-term and long-term disability coverage, a 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
MapLight Therapeutics fosters a collaborative and innovative work environment, focusing on drug discovery for central nervous system disorders. The company combines cutting-edge technologies to identify novel drug targets and develop effective therapies, offering employees the opportunity to contribute to meaningful advancements in psychiatric treatment.