Manager, Quality Management System (QMS) and Compliance

$120,000 - $150,000/Yr

Zenas BioPharma - Waltham, MA

Full-time - Mid Level

Hybrid - Waltham, MA

Professional, Scientific, and Technical Services

About the position

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation!

Responsibilities

• Provide guidance on all aspects of the Quality Management System (QMS) (e.g. training administration, document control, deviations, investigations, CAPAs, change control, supplier management program, and associated governance).
• Support decision making on implementation to ensure alignment with strategic plans, operational effectiveness, and effectively communicate throughout implementation activities.
• Support implementation and qualification of software for all Quality Management Systems as needed.
• Support quality improvements to maintain compliance and improve efficiency as part of continuous improvement initiatives.
• Provide system oversight, ensure system compliance, and usage to regulatory and corporate requirements as they relate to training, document control, and lifecycle records management.
• Ensure rapid communication of Quality issues, including issues of significant deviations with project/products, to business partners and senior management.
• Coordinate content and readiness for quality management review meetings, ensuring that key quality metrics, trends, and improvement actions are effectively monitored and summarized.
• Support inspections, audits, global submissions, and dossier approvals.
• Participate in inspection readiness across the GxP departments.

Requirements

• Bachelors' degree and 5 years' experience engaging Quality activities within a cGMP environment in the Biopharmaceutical industry.
• Knowledge of Quality Assurance principles, practices, and standards.
• Knowledge of Veeva systems recommended.
• Ability to perform as an individual contributor capable of driving work independently.
• Efficacy and efficiency in making and acting on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.
• Flexibility to work non-traditional work hours when needed, given international operations across time zones.
• Excellent communication and interpersonal skills, with the ability to effectively interact with cross-functional teams, senior management, and external stakeholders.

Benefits

• Annual performance bonus
• Equity
• Full range of benefits
• Other incentive compensation plans