Quality Assurance Manager

Overview of this Position: The Quality Assurance Manager leads quality oversight for sterile manufacturing operations, ensuring full compliance with FDA regulations, EU GMP, and Annex 1 requirements. This role is responsible for batch record review and lot release, as well as driving robust deviation investigations and CAPA management to maintain product sterility assurance and regulatory compliance. The QA Manager partners closely with manufacturing, quality control, and engineering teams to support efficient production while upholding the highest standards of aseptic processing and contamination control in a dynamic, growth-oriented environment.

Non-Negotiable Requirements:

• Bachelor’s degree in biology or related field

• Strong working knowledge of FDA regulations, EU GMP, and Annex 1

•Proven working experience in lot release, deviation management, and CAPA systems

•Experience supporting regulatory inspections and audits (FDA/Client)

•Excellent problem-solving, communication, and leadership skills.

 Preferred Requirements:

•Experience with electronic quality management systems (eQMS).

•Strong understanding of risk management principles (e.g., ICH Q9).

•Ability to manage multiple priorities in a fast-paced environment.

 Responsibilities Include:

• Ensure operations are conducted in accordance with applicable FDA regulations, EU GMP requirements, and Annex 1 guidance for both sterile and non‑sterile manufacturing activities

•Review batch records and supporting documentation in accordance with approved procedures to ensure product quality and data integrity prior to disposition

•Lead and support deviation investigations, including documentation of root cause analysis and implementation of timely, compliant resolutions

•Develop, implement, and track Corrective and Preventive Actions (CAPAs) in alignment with quality system requirements to mitigate recurrence of identified issues

•Review and approve SOPs, protocols, and validation documentation related to sterilization processes, aseptic filling, cleaning, and gowning practices

•Ensure personnel qualification and training requirements for aseptic operations— including media fills and gowning qualifications—are maintained, current, and effective

•Support internal and external audits, including regulatory inspections, and maintain a state of audit readiness; serve as a subject matter expert for sterile manufacturing and Annex 1 compliance when required

•Partner with Manufacturing, Quality Control, and Regulatory Affairs to ensure alignment on quality standards, expectations, and regulatory commitments

•Monitor quality metrics and performance indicators to identify trends and support continuous improvement initiatives

•Provide guidance and training to QA personnel and cross‑functional teams on quality systems, compliance expectations, and best practices; support departmental operations and staff development

The duties listed above are intended to describe the essential functions of this position. Additional responsibilities may be assigned as needed. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods, using a computer, and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.