Senior Manager, Quality Systems & Compliance

MacroGenics, Inc.•Rockville, MD

7h•$137,700 - $210,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Experience maintaining clinical-stage quality assurance programs
Experience developing and/or managing quality systems for a biopharma company with an outsourcing model
Ability to perform GMP supplier audits
Experience ensuring compliance with GLPs and GCPs from a quality perspective

Responsibilities

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.