Apnimed is a rapidly growing pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea (OSA) could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program, AD109, targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Apnimed is committed to innovation, as well as state-of-the-art advancements in sleep medicine, which is leading to the development of a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Recognized by the Boston Business Journal as one of the Best Places to Work in both 2024 and 2025, we are continuing to grow and build the foundational operations that enable our employees and our mission to thrive. Summary : The Senior Manager, Quality Systems support regulatory inspections and audits through preparation of records, reports, metrics, and system demonstrations; and monitor industry trends and regulatory expectations. Present quality system performance trends and recommendations to Quality leadership, lead or support continuous improvement initiatives, and collaborate cross-functionally to standardize quality processes across departments. Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline. 8+ years of Quality Assurance, Quality Systems, or Quality Management experience within the pharmaceutical, biotechnology, or life sciences industry, including: Demonstrated experience managing electronic Quality Management Systems (eQMS), including administering or supporting platforms such as Dot Compliance, Veeva Quality, MasterControl, TrackWise Digital, ComplianceWire, or similar. Working knowledge of FDA, EMA, ICH, GCP, GMP, and GLP requirements. Experience supporting regulatory inspections and external/internal audits. Preferred: Direct administrator experience with Veeva Quality, and experience with computerized system validation (CSV) and 21 CFR Part 11 compliance. Preferred: Experience supporting both development-stage and commercial pharmaceutical operations, and implementing or enhancing eQMS platforms. Ability to manage simultaneous priorities and changing deadlines. Excellent oral and written communication skills. Strong analytical, organizational, and project management skills. Proficiency in the use of MS Word, PowerPoint; experience with Adobe Acrobat Professional. 401(k) with company match Generous time off for vacation Generous healthcare benefits Flexible working environment Motivated and experienced team Winner of 2024 and 2025 Boston Business Journal Best Places to Work Location and Other Information: Apnimed is a publicly licensed company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical. We are a small growing Company with an inclusive environment. Must be able to travel as necessary. Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment. Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea.
Senior Manager, Quality Systems and Compliance employer: Apnimed
Apnimed is recognized for its innovative approach to treating sleep apnea, offering competitive salaries and a supportive work environment. Employees benefit from opportunities for professional growth and collaboration across various departments. The company's commitment to employee satisfaction is reflected in its accolades as a top workplace.
