Senior Manager, Quality Systems & Compliance

MacroGenics 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. MacroGenics' 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.

Summary of 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.

Responsibilities and Job Duties

• 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.

Qualifications

Education, Credentials & Experience

• 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, Skills and Abilities

• 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

Supervisory Responsibilities

May direct work of or delegate work to contractors

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

Additional Information

The annual rate of pay for this position ranges from $137,700 - $210,000. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including 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, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.