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.

MacroGenics is a bold, highly engaged, and diverse team driven by a passion for improving the lives of patients through innovative science. We are committed to an inclusive workplace built on trust and respect. We value and nurture strong connections with one another and foster collaborative relationships. We empower our people and drive personal accountability. We encourage curiosity and embrace our entrepreneurial spirit. We celebrate our successes and create a learning environment where all employees can thrive!

Summary of Position

This position is responsible for representing the Quality Assurance (QA) Operations department providing strategic development, quality leadership, project management and technical knowledge/key support to all aspects of a project. Individual will be fully competent in Quality Assurance systems and understanding how they interlink with other business systems. Individual will help lead the Quality Assurance (QA) organization to generate a strong quality culture and continuous improvement mindset by building and maintaining strong working relationships with internal stakeholders which may include QC, Manufacturing, Facilities, Supply Chain and Development and encourage collaborative/supportive working within the different departments and across functional interfaces.

Responsibilities and Job Duties:

• Through active engagement with the Quality management team and internal stakeholders, helps define GxP practices and standards for the site and leads gap assessments and improvement projects as required to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
• Evaluates QA Operations processes and procedures to ensure efficiency and compliance with regulations and applicable guidances.
• Champions and facilitates/actively participates in development/improvements of QA Operations processes and procedures working effectively with internal stakeholders as required.
• Manages multiple projects with moderate complexity.
• Develops and implements project plans, conducts risk assessments and develops contingency plans to accommodate unforeseen events, ensures milestones are met and prioritizes as required to meet commitments.
• Prepares and presents project progress reports to keep management and team informed. Identifies problems, their resolution, trends, and their impact on project success; proposes recommendations for management action.
• Anticipates, recognizes, communicates, and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues with focus on increased productivity and improved compliance.
• Provides Quality leadership to cross-functional teams working on risk assessment, root cause analysis, and other investigative tools to ensure a holistic and systemic quality approach is embedded in all aspects of the Quality Management system.
• Applies risk management processes and principles and creates and utilizes risk analysis tools when assessing quality related issues.
• Provides advice and direction to other departments on quality issues.
• Provides advice and direction for the implementation of proper CAPA to resolve deviations and non-conformances.
• Supports review and approval of change controls, deviations and non-conformances, failure investigations, suspect analytical results, product quality complaints, and other operational quality events.
• Supports product release when required.
• Writes, reviews and approves QA SOPs supporting QA Operations responsibilities.
• Participates on internal committees/cross functional teams as the Quality Assurance representative as required.
• Provides training to staff to increase understanding of the regulatory GMP requirements and implementation of best practices.
• Promotes compliance across the site by adherence to, Quality Policies, SOPs and training programs.

Qualifications

Education & Credentials

Bachelor's degree in life sciences or a related area of study or other related field equivalent work experience.

Experience

• A minimum of 8 years in a GxP environment.
• A minimum of 7 years of experience in quality assurance and/or quality compliance within a biopharmaceutical or pharmaceutical manufacturing environment.

Knowledge, Skills and Abilities

• Strong understanding and demonstrated knowledge, interpretation and application of US, EU and ICH GMP regulations and guidances.
• Demonstrated leadership skills and demonstrated success in influencing without authority with a strength of character to guide cross functional teams.
• Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization.
• Excellent communication, negotiation, and risk-based decision-making skills, promoting openness, dialogue and collaboration.
• Competent problem solving, risk assessment and impact analysis abilities. Demonstrated knowledge and application of risk assessment tools.
• Demonstrated strategic and analytical (structural/logical) thinking capability with project management skills, with the ability to focus on execution of decisions while balancing multiple priorities.
• Must be able to critically interpret problems, data and effectively communicate in an impactful manner to management, and the broader organization with clarity and a high level of brevity and accuracy.
• Capable and confident communicator (both verbal and written) at all levels.
• Demonstrated training, coaching and mentoring skills.
• Hands-on-approach with an enthusiastic can-do approach.
• Proficient using MicroSoft Office, specifically with MicroSoft Word, Excel, Project, Visio.

Supervisory Responsibilities

None

Preferred Qualifications

• Prior experience with Master Control preferred
• Operational experience within a GMP manufacturing or laboratory setting is desirable
• Leader and key contributor to initiatives and advancement of the Quality organization.
• Wide application of technical principles, practices, and procedures.
• Strong understanding of business unit function and cross group dependencies/relationships.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Has a sound knowledge of various technical alternatives and their impact.

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.

Equal Opportunity Employer/Veterans/Disabled

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.