Senior Manager, Quality Systems & Compliance

Macro Genics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.

Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. Macro Genics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

The Senior Manager, Quality Systems develops, maintains, and improves the Quality Management system, supporting Technical Operations, Quality, and Clinical Development/Operations. This individual plays an integral role in ensuring internal operations, processes and systems of the Quality department are flexible, functionable, and meet phase-appropriate compliance standards. This is a cross‑functional role who serves as the primary liaison to internal customers for all quality system related items associated with GMP, GCP, and GLP, with a strong focus on outsourced GMP operations.

• Responsible for electronic QMS deployment, administration, operation, and improvement. Communicates with other departments to resolve issues, identify and close gaps, and ensure ease of use of the QMS for personnel.
  • Works with IT and external support services to configure the system over time as quality processes mature.
• Develops flexible, clinical phase appropriate site quality systems and processes (training, document control, quality events), applying processes and standards in alignment with the organization's strategy.
• Authors and reviews QMS documentation such as SOPs, work instructions and other controlled document types.
• Owns document management and control for electronic and paper-based systems.
• Owns the company‑wide training program and ensures appropriate company, role‑specific and GxP training is provided to new and current staff.
• Partners cross‑functionally to drive quality operations inspection readiness, makes recommendations and leads continuous process improvement.
• Provides input into quality event processes supporting external GMP operations, including deviations, CAPA, OOS/OOT, change control, SCARs and product complaints.
• Supports and may host regulatory inspections and partner audits.
• Perform other quality duties as assigned.

• Bachelor's degree in a science related field and a minimum of 7 (seven) years of experience working in a GxP environment
• Minimum 5 (five) years experience working with biological products regulated under 21 CFR Part 600
• Prior experience implementing and administering an eQMS for a biopharmaceutical company

• Knowledge of quality systems and USFDA cGMP regulations, industry practices, and international manufacturing regulations.
• Expertise in quality systems for early phase development company
• Proven experience as a quality and compliance subject matter expert
• Strong cross functional communicator with excellent written and verbal communication skills
• Self‑motivator with excellent prioritization skills and resourcefulness in a fast‑paced environment
• Ability to build strong customer‑focus relationships through responsiveness and delivery
• Tactful with promoting quality standards and ability to drive quality improvements
• Ability to operate effectively at both the management and operational level
• Familiarity with biologics manufacturing operations and testing
• Ability to accommodate occasional work outside of regular business hours for system administration or troubleshooting
• Expertise in authoring and designing deviation, CAPA, OOS/OOT, SCAR, product complaint and change control processes
• Travel up to 10% may be required for business support, training and development opportunities