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Senior Manager, Quality Systems & Compliance

MacroGenics, Inc. · Rockville, MD · Yesterday
On-siteQuality Assurance$138k–$210k/yrFull-time

About the Role

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, functional, 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.

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.
  • Performs other quality duties as assigned.

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.

Skills

  • 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.

Preferred Qualifications

  • 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.

Supervisory Responsibilities

May direct work of or delegate work to contractors.

Travel

Up to 10% may be required for business support, training, and development opportunities.

Pay

The annual rate of pay for this position ranges from $137,700 – $210,000. This role is eligible for the Company’s discretionary bonus and discretionary equity incentives.

Benefits

  • Medical / dental / vision / prescription coverage.
  • Employee wellness resources.
  • 401(k) plan with employer match.
  • Access to an Employee Stock Purchase Plan (ESPP).
  • Paid time off & paid parental leave benefits.
  • Disability benefits.

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