QA Manager Quality Assurance
Armata Pharmaceuticals is a clinical-stage biotechnology company advancing the development of precisely targeted bacteriophage therapeutics for the treatment of drug-resistant bacterial infections.
The QA Manager will support process development, manufacturing and clinical operations by implementing and maintaining quality systems that ensure compliance with internal and regulatory requirements and expectations.
- Partner with Production and Facilities, Quality Control, Clinical Operations and other operations colleagues in ensuring high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Clinical Practices (GCPs)
- Implement and maintain quality systems including, but not limited to, document control, change control, internal and external audits, GMP training, and validation
- Lead process deviation investigations and insure timely completion of corrective and preventive actions (CAPAs)
- Support quality assessments of internal operations to analyze quality compliance and assess risk
- Ensure process control measures are in place and followed in product manufacturing
- Maintain internal and external audit program to ensure GMP compliance
- Coordinate the preparation and submission of Investigation New Drug (IND) applications and IND annual reports and their equivalent in non-U.S. jurisdictions
- Maintain GMP training program
- Direct the activities and career development of assigned staff
- Understand and comply with company standard operating procedures and safety procedures
- Read and understand scientific language, literature and publications as necessary
- Other duties as assigned
|Minimum & Preferred Qualifications: Prior experience in the pharmaceutical industry is requiredMust have a Bachelor of Science (BS) degreeMinimum of 4 years of hands on experience using quality system processes such as investigations, change control, document management, validation, trainingMinimum of 5 years of experience in a GXP regulated environmentStrong technical writing skills including experience authoring and editing regulated documents Strong verbal and written communication skillsAbility to review and comprehend regulatory/quality documentationTraining skills and proven ability with risk-based quality management system or other applicable process improvement methodologyStrong working knowledge in Microsoft Office applications is requiredMust be reliable, organized, detail oriented, and a self-starter with the ability to prioritize and work with minimal supervisionStrong team-player and able to work well in small groups and independently Working Conditions: This is a full-time position for work in an office and GMP manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. There is little travel required of this position with the exception of required training and possible conference or event attendance.|
Position is salaried and is eligible for performance bonus. Pay is competitive and commensurate with skill set and experience. Benefits include medical, dental, vision and life insurance, vacation plan, and 401(k). Consideration for future stock option grants may be available.
Send cover letter and CV to: email@example.com