Associate Manager/Manager, Quality Assurance

QA Manager

The QA Manager ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing documentation for all quality system functions in accordance with cGMP and related company SOP's, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.

Responsibilities include managing and ensuring that facility meets all GMP, FDA and SOP requirements. The QA Manager will be responsible for managing all quality operations to include inspection of components, bulk, and final products for the Chantilly, VA, ensuring release lead times are met with timely product disposition. They will ensure that the facility is meeting all training requirements. The QA Manager will lead the communication of open quality document notification and resolution between all departments regarding Complaints, Investigations, Change Control, CAPA's (including verification of CAPA's) and other quality documents as needed. They will manage and maintain audit inspections (Internal and External) for the site. The QA Manager will be responsible for supporting the preparation, review, processing, and approval of various validation documents as application for the Granules, Chantilly, facility. They will provide QA support, review and approval for relevant documents including relevant procedures, batch records, specifications, stability reports, technical reports (i.e., Qualification, Validation, Transportation.), trend reports, Annual Product Quality Reviews and other documents as needed. The QA Manager will be responsible for performance and development of all Quality Assurance staff through mentoring and focusing on personal and professional growth. They will work with Quality leadership team for proactive succession planning and a high-performance culture through people. The QA Manager will guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year. They will provide the means for incorporating the necessary tools, equipment, and methods into the new and existing processes aimed at continuous improvement. The QA Manager will implement Quality management system tools and their compliance. They will develop and execute quality training modules for the organization. The QA Manager will ensure staff receives appropriate knowledge and skill development and growth opportunities. They will work with Regulatory Affairs to supply information needed for FDA filings. Other duties as assigned by management.

Knowledge & Skills include expert-level knowledge of the FDA guidance for Industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc...), cGMP compliance within the pharmaceutical manufacturing industry, writing and maintaining cGMP documentation, analyzing data/information and resolving complex issues, verbal and written communication skills, working and communicating with cross-functional teams, multiple priorities and re-prioritize tasks, strong computer skills and working knowledge of Microsoft Office Suite and Adobe, demonstrated ability to work on complex assignments in collaboration with various departments.

Experience & Education include Bachelor's degree in the life sciences (or equivalent work experience) minimum of 6+ years in a QA role within the pharmaceutical industry. Master's degree with 4+ years of pharmaceutical manufacturing experience and at least 3 years of those years in a progressive challenging QA department in the pharmaceutical industry.

Physical Requirements/Working Environment include standing, sitting, talking, hearing, and using hands and fingers to operate a computer and telephone keyboard. Specific vision abilities required by this job include close vision requirements due to computer work. Ability to sit at a computer terminal for an extended period of time. Light to moderate lifting up to 10-15 lbs is required. Ability to work in a confined area.