Associate Director, Manufacturing QA

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.


The Senior Manager, Manufacturing Quality (Senior Manager, MQA) role reports directly to the Quality Site Head. The Sr. Manager of Quality Operations is responsible for overseeing day-to-day QA activities related to manufacturing operations, ensuring compliance with GMP standards and internal quality policies. This role supports batch record review, deviation investigations, and QA presence on the manufacturing floor. The Sr. Manager will lead a team of QA professionals and collaborate cross-functionally to drive continuous improvement and ensure timely batch disposition.

Responsibilities

• Implement and maintain "QA on the floor" practices to support GMP manufacturing.
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• Lead QA Operations team in reviewing batch records, manufacturing documentation, and ensuring timely batch disposition.
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• Provide QA oversight for Drug Substance and Drug Product manufacturing processes.
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• Support review and approval of Master Batch Records and associated documentation.
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• Collaborate with internal stakeholders and clients to address quality-related issues, including deviations and audit findings.
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• Participate in client audits and regulatory inspections as needed.
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• Ensure compliance with applicable regulations (US, EU, ROW), cGMP, 21 CFR, USP, and internal quality standards.
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• Maintain effective communication with project managers and manufacturing teams to align on timelines and deliverables.
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• Drive continuous improvement initiatives within QA Operations.
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• Train, mentor, and develop QA staff to ensure high performance and engagement.
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• Collaborate directly with clients to resolve issues (e.g., client comments on executed batch records, root cause investigation for major or critical deviation) and participate in client audits.
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• Provide support to manager and SLT as needed.
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Qualifications

• Bachelor's degree in science or engineering with a minimum of 5 years of relevant experience including leading and developing teams.
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• Relevant experience as a quality leader.
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• Knowledge of industry standards and regulation requirements for biologics and parenteral substances in clinical development and commercial.
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• Knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
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$140,000 - $170,000 a year

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.