Quality Assurance Specialist – GMP

Quality Assurance Specialist – GMP

FULLY REMOTE

Temporary Assignment Through Outside Agency - Approximately 6 Months

Approximately 40 Hours Per Week

#26-03AT

Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.

The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high-quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.

The Quality Assurance Specialist - GMP is an individual contributor who is an experienced GMP employee functioning as a key member of the Quality Assurance team who also partners with the CMC, and as needed, non-clinical, and clinical development functions. Additionally, the successful candidate partners with Principal Investigators and the program teams to deliver on Mapp's portfolio.

Basic Qualifications

• BS/BA Degree in a related Science; MS Degree in related Science preferred
• 10+ Years of Development experience in a regulated pharmaceutical industry, preferably within a Biologics/mAb Product Development environment
• 10+ Years of experience in a QA-GMP role in Drug Substance and/or Drug Product activities
• Possesses the knowledge to act as a SME on any QA-GMP issues
• Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance and Drug Product manufacturing activities
• Direct experience in providing QA oversight for cGMP manufacturing operations
• Knowledge of GMP drug development regulations
• Previous technical CMC experience with large molecule (preferably monoclonal antibody) Drug Substance and/or Drug Product development/commercialization
• Previous experience with auditing biological and parenteral manufacturing facilities, laboratories that perform regulated activities
• Experience overseeing GMPs (as a Sponsor) at third-party locations

Preferred Qualifications

• Experience across all phases of biologic drug development (Clinical phases 1 through 4 of drug development)
• Knowledge of additional drug development regulations such as GCPs and GLPs
• Previous experience supporting Pre-approval Inspections is desirable
• Experience working virtual

Responsibilities

Mapp Focused

• Provides quality oversight for cGMP manufacturing and batch release
• Partners with all CMC functional team members to assure the advancement of the integrated CMC program scope or work
• Reviews and approves GMP protocols, reports, Standard Operating Procedures, documentation, and any other relevant documents to ensure GMP compliance
• Participates in assigned Program team meetings and stakeholder meetings as required
• Contributes to the development and maintenance of the global quality systems in line with current regulatory requirements, meeting US FDA and ICH requirements, and others as needed
• Supports deployment and implementation of GMP practices, policies and procedures
• Acts as assigned as point of contact with regulatory authorities regarding quality-related issues at third party GMP manufacturing sites
• Reports all critical and relevant Quality compliance matters to the Head of Quality Assurance
• Ensures required Quality Assurance management and quality expertise is available and effective for operations
• Participates as assigned in the deployment of effective internal and external GMP audit programs
• Ensures, where appropriate, that all Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time
• Ensures escalation to the Head of Quality Assurance and program team leadership of all critical concerns from the site related to product quality issues encountered at sites and the partner's quality system
• Ensures that QA team maintains appropriate independence in order to ensure that there is no conflict of interest between regulatory requirements and day-to-day operational priorities
• Ensures risk management principles, the essence of ICH Q10, and a continuous improvement culture are built into QA ways of working
• Authors, as assigned, Mapp Standard Operating Procedures (SOP's) related to GMP and other Mapp QMS related activities

Partner Focused

• Acts as a SME on any QA-GMP at the partner sites and internally for program teams
• Provides QA oversight for all cGMP activities at the GMP manufacturing, packaging, and labeling sites including, but not limited to, review and approval of all manufacturing documentation (batch records, process flow documents etc. ) and final release of GMP material
• Supports, as assigned, the evaluation/selection of potential contract manufacturing organizations (CMOs)
• Provides quality input for technology…