About this position:
The QA Manager, under the direction of the Associate Director of QA & Regulatory Affairs, will support process development, manufacturing and clinical operations by assisting in the implementation and maintenance of quality systems that ensure compliance with internal standards and expectations and regulatory requirements.
Job description and technical requirements:
- Partner with Production, Facilities, Quality Control, Clinical Operations, Product Development and other functions in ensuring high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Clinical Practices (GCPs).
- Train junior quality assurance staff and oversee their daily tasks and schedules.
- Prepare and lead regularly scheduled quality meetings with internal stakeholders from other functions.
- Identify, remedy and escalate any gaps or non-compliance with quality and regulatory standards to Associate Director of QA.
- Drive continuous improvement efforts on Quality and cGMP operations.
- Review Polices, Standard Operating Procedures (SOP), Master Batch Records, Forms, Reports, and equivalent documents for compliance to internal procedures and external GxP regulations.
- Oversee the release of Raw Materials and disposition of nonconforming materials.
- Lead the implementation and management of electronic quality management system.
- Manage Quality Systems including, but not limited to change control, document control, training, deviations and CAPA.
- Support and advise cGMP Operation functions on nonconformance investigations, qualification of cGMP equipment and systems, method transfers, and change control.
- Participate in quality risk assessments of internal operations to analyze risk and identify mitigations.
- Assist in the conduct of internal and external audits to ensure cGMP compliance.
- Understand and comply with company standard operating procedures and safety procedures.
- Other duties as assigned.
Qualifications and Experience:
- Prior experience in the biotechnology or pharmaceutical industry is required.
- Must have a Bachelor of Science (BS) degree. Advanced degree is preferred.
- Minimum of 5 years of hands-on experience using quality system processes such as investigations/CAPAs, change control, document management, validation, training, supplier qualification, internal/external audit, material release, batch release/disposition
- Minimum of 5 years of experience in a GXP regulated environment
- Strong technical writing skills including experience authoring QA SOPs
- Strong verbal and written communication skills
- Strong working knowledge in Microsoft Office applications is required
- Must be reliable, organized, detail oriented, and self-motivated
- Strong team-player and able to work well in small groups and independently
This is a full-time position for work in a laboratory environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. There is little to no travel required of this position, with the exception of required training and possible conference or event attendance.
About Armata Pharmaceuticals, Inc.:
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.