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 transfers to CMOs
• Establishes and maintains quality agreements with CMOs to ensure adherence to regulatory requirements
• Provides QA support for identification of risks, risk assessments, action plans, remediation plans for any GMP manufacturing and testing deviations and investigations at partner sites
• Functions, as assigned, as Lead Auditor for GMP manufacturing, testing, packaging, labeling, and storage vendors, and supports other functional vendor audits as needed
• Influences a strong quality and compliance culture at the partner and contractor sites
• Contributes as subject matter expert for matters relating to formal quality management and regulatory compliance at Mapp's partner sites in collaboration with the Head of Quality Assurance
• Partners with key customers on Quality system execution
• Acts as primary contact for discussions on Quality matters with key customers and contractors
• Deploys the quality and compliance strategy to deliver strategic business objectives at partner site - in conjunction with the applicable site
• Ensures the existence/establishment of effective manufacturing control at partner sites
• Ensures enforcement of investigation of non-conformances, as well as fraud
• Ensures partner sites are "audit ready" and compliant at all times
• Ensures, where appropriate, that all personnel training, investigation, deviation actions, critical documentation and audit actions at the manufacturing sites are completed on time
• Writes audit plans and other documents
• Maintains confidentiality

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. Mapp's anticipated pay scale for this position is $62.50 to $103.37 per hour, which is equivalent to an annualized rate of $130,000 to $215,009.60. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. Currently this opening is a temporary position only through an agency, although if it converts to regular Mapp employment, the following benefits would apply: Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short- and long-term disability, and a 401K plan that includes Company contributions to eligible employees. Full-time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.

Willingness to potentially travel (Domestic Travel = Approximately Once a Quarter + International Travel = Approximately Once Per Year) may be required for this position.

Mapp invites you to apply by submitting your information through the Mapp Biopharmaceutical, Inc. Job Openings website page. This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

Mapp is an equal opportunity employer and employment decisions are not based on any protected status. Mapp uses a wide variety of advertising and outreach to find qualified applicants for employment.

Mapp is an Equal Opportunity Employer/Veterans/Disabled.