Manufacturing Operations Quality Advisor (cGMP/Medical Products)

Type of Requisition:

Regular

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Public Trust/Other Required:

NACI (T1)

Job Family:

Functional Experts

Job Qualifications:

Skills:

cGMP Compliance, Communication, Manufacturing Compliance

Certifications:

None

Experience:

10 + years of related experience

US Citizenship Required:

Yes

Job Description:

Seize your opportunity to make a personal impact as a Manufacturing Operations Quality Advisor supporting the Defense Health Agency . GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career.

At GDIT, people are our differentiator. Our work depends on having a detail oriented Manufacturing Operations Quality Advisor to utilize their experience in the area of Manufacturing Compliance and Risk Mitigation of drugs, biologics, and blood products. This position will focus on ensuring products in development follow Good Manufacturing Practices (cGMPs) per FDA 21 CFR (Code of Federal Regulations).

HOW YOU WILL MAKE AN IMPACT:

• Serve as a top level technical or functional expert, providing guidance/ consultation to Product Managers (PdMs) as needed to enable informed decision making and risk analysis.
• Provide support to product development efforts focused on manufacturing compliance and risk mitigation aspects for various product development efforts of maturity that spans from early clinical (phase 1) to late clinical development (phase 3) and beyond. This work directly supports medical product development for a variety of combat casualty care and infectious disease programs.
• Be a substantive participant in Integrated Product Teams (IPTs) and provide input regarding technical and compliance of biopharmaceuticals (including blood products) and risk management/mitigation.
• Collaborate as necessary to identify regulatory affairs (RA) strategies that will optimize product development.
• Provide subject matter expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC); assess CMC related risk of commercial partners; and perform audits and provide GMP compliance advice.
• Conduct risk assessments, vendor qualifications and for-cause audits.
• Advise the PdMs and Project Managers (PjMs) in regard to issues involving regulatory compliance and risk.
• Support the review of PWS’ and provide input regarding manufacturing compliance requirements of the effort.
• Conduct Quality Assurance reviews of GMP manufacturing  related documents (SOPs, Analytical Methods, Manufacturing Methods, Batch Production Records, Campaign Summary Reports, Stability Reports, Release Testing, Deviations, and CAPAs).
• Assist Development partners and Contract Manufacturing Organization (CMO) in cGMP compliance and inspections by regulatory health authorities.
• Provide expert written reviews, briefings, and recommendations to PdMs for developmental medical projects to include reviewing and interpreting results with an emphasis on compliance with FDA requirements. 
• Provide review of documents that will be submitted to the FDA or other Governmental or Military organizations.
• Successfully communicate with personnel at various echelons through the use of effective interpersonal and communication skills.
• Manage numerous efforts and effectively prioritize and multi-task requirements that have a direct impact on the Program.
• Attend and participate in site visits and provide product support in IPT meetings and briefings, etc.
• Facilitate meetings with contractors to track Technical Transfer activities with CMOs.

WHAT YOU'LL NEED TO SUCCEED:

• Education: Master's degree in related field, or the equivalent combination of education, professional training or work experience.
• Required Experience: 10+ years of experience in regulated manufacturing compliance.
• Required Technical Skills: Have knowledge/experience with cGMP and regulatory requirements.  Have familiarity with IND amendment submissions, technical transfer with CMOs, start-up commissioning of a new contract facility, and qualification and validation of equipment and processes.
• Security Clearance Level: No clearance, however must be able to obtain a T1 (Public Trust)
• Required Skills and Abilities: Excellent verbal and written communication skills to communicate with personnel at various echelons. Intermediate experience with Microsoft Office Sui