Location: San Diego, CA
Company: Mapp Biopharmaceutical
support of biodefense programs. The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biomedical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory and Clinical activities consistent with Mapp's product development objectives.
The Director of Quality Assurance - GCP partners with Quality Assurance leadership to ensure synergistic alignment of Operations/Quality Assurance functions. Provides leadership for all Quality Assurance GCP related activities at the partner and CRO sites. Basic Qualifications BA/BS Degree
in a related Science; MS Degree in a related Science preferred 10+ Years of Development experience in a regulated medical industry with a significant amount of this time in a role that has GCP compliance expectations interacting with both Quality Assurance and clinical personnel Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development) Knowledge of drug development regulations such as the US and ICH GCP's Auditing of partner organizations Ability to effectively manage multiple projects to meet timelines, technical and GCP-quality requirements Maintains confidentiality Ability to work in teams with diverse cultural and professional backgrounds Travel
required (up to 20% domestic travel) Preferred Qualifications Experience working in a virtual biotech setting Large molecule and/or biologics experience Responsibilities Mapp Focused Reviews GCP protocols, GCP study reports, and Standard Operating Procedures to ensure GCP compliance and assists the Clinical team with GCP compliance for clinical activities Ensures deployment of the GCP-Quality Assurance strategy as approved by senior management Contributes to GCP maintenance of the quality system, as directed Reports all critical and relevant Quality compliance matters to the head of Quality Assurance Ensures required Quality Assurance expertise is available and effective for GCP study execution Ensures internal and external GCP audit programs are deployed and effective Ensures Quality Assurance review and approval/rejection of all GCP related procedures, documents and records Ensures, where appropriate, that all Mapp GCP related investigations, deviations, audit and critical documentation activities are complete and compliant to support GCP activities Ensures risk management principles, the essence of ICHQ10 and a continuous improvement culture are built into QA ways of working Ensuring deployment of Quality Strategy as approved by senior management Support deployment and implementation of HIPPA and Gx P's Collaborating with and supporting Operations leadership as well as Corporate leadership Acting as point of contact with regulatory authorities regarding issues at the partner and clinical trial sites, as well as (CRO's) Clinical Research Organizations Supporting the development and harmonization of quality standards and processes Establishing compliant policies, procedures and specifications Ensuring regulatory commitments are met on time and sustainability measures are in place Maintain good relationship with Regulatory bodies as well as Food and Drug Administration (FDA) inspectors Ensuring required Quality Assurance management and quality expertise is available and effective for operations Ensuring where appropriate that all Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time Ensuring escalation to the Head of Quality Assurance and leadership of all critical concerns from sites related to product quality issues encountered at the CRO and partner's quality system Assists in constructing annual GCP training Leads or assists in authoring Clinical Standard Operating Procedures (SOP's) Acts as Gx P back-up for other members of Quality Assurance Partner Focused Influences a strong quality and compliance culture at the partner and contractor sites Acts as a SME on any QA-GCP issues at the partner sites Contributes as subject matter expert for matters relating to formal quality management and regulatory compliance at Mapp's partner clinical sites in collaboration with the Head of Quality Assurance Partners with key GCP customers on Quality system execution Acts as primary contact for discussions on GCP Quality matters with the clinical team, and key customers and contractors Acts as point of contact with regulatory authorities regarding issues at Clinical sites as needed Ensures GCP quality requirements are met Ensures enforcement of investigation of non-conformances, as well as fraud Ensures the Clinical sites are " audit ready" and compliant at all times Ensures, where appropriate, that all partner personnel training, investigation, deviation actions, critical documentation and audit actions are completed and compliant for GCP activities Writes GCP audit plans and other GCP-related documents 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 $130,000 to $250,000 plus any applicable bonuses. 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. 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. If your job responsibilities allow, you may choose to work remotely. Willingness to Travel (Domestic Travel = Approximately 20%) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through mappbio. /jobs/. No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
Job Posted by Applicant Pro
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.
Quality Assurance (QA) jobs involve ensuring that products or services meet certain standards of quality before they reach the consumer. Individuals in QA roles are responsible for planning and implementing inspection processes, conducting tests, and analyzing the results to detect defects. They work to prevent errors and improve the overall quality of the final output. Key characteristics of QA jobs include attention to detail, a systematic approach to problem-solving, and a strong understanding of industry-specific regulations and quality standards. These professionals play a critical role in customer satisfaction and maintaining the reputation of a brand or company.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
