MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with canceras well as various autoimmune disorders and infectious diseases.Our products and platforms have attracted multiple partnerships with leading pharmaceutical 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 Director/Director, Quality Assurance is responsible for leading and managing the GMP Quality Assurance organization. This person is accountable for the continuous development, execution and administration of a GMP Quality system which meets all compliance requirements with respect to cGMP as defined by global regulatory authorities and guidance. The Senior Director of GMP Quality Assurance will develop, maintain, and continually improve the Quality Management System, the Quality Assurance Program, as well as provide Quality and Compliance oversight for the Manufacturing and Supply Chain processes of MacroGenics' clinical and commercial products.
Responsibilities and Job Duties:
- Support the VP, Quality with strategic planning of the global quality management system (QMS). Establish short and long-range quality plans and objectives related to the QMS
- Lead the GMP Quality Assurance team to ensure adherence to company policies and procedures, regulatory and compliance requirements. Represent GMP Quality Assurance to external parties to demonstrate cGMP compliance, including partners and regulators.
- Oversee the development, implementation and maintenance of the QMS to ensure compliance with domestic and international GxP regulations and Company policies and procedures. Provide guidance, interpretation, support, training and input on regulations, guidelines, Company procedures and policies.
- Lead the preparation and execution of readiness plans for inspections by domestic and global regulatory authorities and audits from business partners. Provide leadership and support during the conduct of inspections/audits and for the identification and execution of any follow-up activities. Serve as the inspection/audit host, as assigned
- Establish and maintain phase appropriate cGMP compliance for all products manufactured, including internal production and external production facilities. Ensure a system of quality assurance is effective in batch disposition decisions.
- Develop and oversee the implementation of processes that manage batch disposition activities to meet company production schedules and distribution requirements.
- Establish and monitor quality metrics/trends and facilitate continuous improvement activities
Build and develop an organization of Quality Assurance leaders who ensure that best practices in cGMP compliance and biotechnology manufacturing processes, are identified and implemented to fully support MacroGenics' mission.
- Champion best practices with respect to the recruitment, selection, onboarding, training and development of the QA staff.
- Create and manage to departmental budgets within corporate targets.
Education & Experience
- Bachelor's degree, or higher, in biological sciences or related field
- Minimum of 12 years in cGMP environment, with at least 10 years of GMP Quality Assurance experience with increasing responsibilities.
- Minimum of 10 years in cGMP environment, with at least 8 years of GMP Quality Assurance experience with increasing responsibilities.
- Biotechnology experience, including both clinical and late clinical / commercial production
- Successful track record managing and developing large teams of people
- Experience with Implementation and maintenance of electronic solutions
- Prior experience preparing for and hosting regulatory inspections, particularly from US FDA and EU member states
Knowledge, Skills and Abilities
- Excellent prioritization skills
- Strong cross functional communicator
- Ability to lead managers who are responsible for directing and guiding others
- Individual must possess the ability to influence without direct authority
- Must possess excellent written and verbal communications skills
- Results driven with demonstrated successful outcomes
- Ability to recognize obstacles and barriers, and drive solutions and positive outcomes
- Ability and desire to lead diverse employees in a cooperative and friendly manner
- Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database)
Position will supervise an organization, with middle/lower management as direct reports and indirectly junior individual contributors through to lower management/supervisors
- Direct experience with ensuring compliance with US and EU cGMPs, additional regions desirable
- Maintaining commercial and clinical-stage quality assurance programs
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 firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service.
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