Sr. Director/Executive Director, Quality Control

The Sr. Director/Executive Director, Quality Control is responsible for leading and strategically directing the Quality Control organization and is accountable for the continuous development, execution and administration of a Quality Control function meeting all compliance requirements with respect to cGMP as defined by US, EU and rest of world regulatory authorities and guidance.

The Sr. Director/Executive Director, Quality Control is responsible for activities including internal QC testing, testing at contract testing labs, contract drug substance, drug product manufacturing organizations (CMOs), commercial and developmental stability (Stability). This individual will work closely with other areas such as Biopharmaceutical Development, Manufacturing, Supply Chain Operations, Quality Assurance and CMC Regulatory Affairs to manage method transfers, method qualification and validation, data oversight and ensure timelines coincide with product development and production schedules. The Sr. Director/Executive Director, Quality Control work extensively with key stake holders to ensure that the Quality Control laboratory is aligned to overall business objectives, and drive a commitment to quality across the organization.

Anticipated Start Date: October 2025

Responsibilities and Job Duties:

• Ensures internal and external quality control testing is performed in compliance with cGMP and maintains data integrity, within a system of quality assurance
• Manages relationships with external partners and vendors to ensure seamless integration methods, data, and/or expertise into internal processes
• Own product specifications, approve certificates of analysis, and ensure product usage is supported by stability data
• Contribute to product regulatory filings and licenses, and leads completion of sections related to Quality Control
• Develop and oversee the implementation of processes that manage batch testing activities to meet company production schedules and distribution requirements
• Build and develop an organization of Quality Control leaders, ensure best practices in Quality Control testing and personnel development are sought after and implemented to fully support MacroGenics' mission
• Create and manage to departmental budgets within corporate targets
• Leads continuous improvement initiatives within Quality Control, and leads key Quality projects within the wider MacroGenics teams
• Stays abreast of industry trends and advancements in quality control methodologies, incorporating relevant innovations into MacroGenics.
• Develops and executes a comprehensive quality control strategy aligned with leading business practices from external bench marks, incorporating long-term goals and initiatives, to drive sustained quality improvement and competitiveness in the market.

Qualifications:

Education & Experience

Sr. Director, Quality Control

• Bachelor's degree, or higher, in biological sciences or related field
• Minimum of 10 years in cGMP environment, with at least 8 years of Quality Control experience with increasing responsibilities and PhD in relevant Quality Control field, or 12 years without PhD

Executive Director, Quality Control

• Bachelor's degree, or higher, in biological sciences or related field
• Minimum of 12 years in cGMP environment, with at least 10 years of Quality Control experience with increasing responsibilities and PhD in relevant Quality Control field, or 15 years without PhD

Knowledge, Skills and Abilities

• Technical understanding of antibody structure, activity and related process impurities
• Individual must possess the ability to influence without direct authority
• Must possess ability to handle multiple priorities in a fast-paced environment
• Must possess excellent written and verbal communications skills
• Results driven with demonstrated successful outcomes
• Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
• Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)
• Biotechnology experience, including both clinical and late clinical / commercial production, including cell-based potency methods and protein separation techniques
• Direct experience of ensuring compliance with US and EU cGMPs, additional regions desirable
• Proven track record in managing priorities, project management, and cross functional communication
• Implementation and maintenance of laboratory information management solutions
• Preparing for and hosting regulatory inspections, particularly from US FDA and EU member states

Supervisory Responsibilities:

Position will supervise an organization, with middle/lower management as direct reports and indirectly junior individual contributors through to lower management/supervisors

Additional Information

The annual rate of pay for this position ranges from $222,200 - $338,800 (Sr, Director, Quality Control) and $237,800 - $362,500 (Executive Director, Quality Control). 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.

Equal Opportunity Employer/Veterans/Disabled

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