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Director, Quality Assurance - GCP
Location:
San Diego, CA
Description:
Director, Quality Assurance - GCP FULLY REMOTE Job #23-02A 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 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 pharmaceutical 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 GxP'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 GxP 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 https://mappbio.applicantpro.com/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, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. Job Posted by ApplicantPro
Company:
Mapp Biopharmaceutical
Posted:
December 26 2023 on ApplicantPro
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More About this Listing: Director, Quality Assurance - GCP
Director, Quality Assurance - GCP is a Quality Assurance QA Job at Mapp Biopharmaceutical located in San Diego CA. Find other listings like Director, Quality Assurance - GCP by searching Oodle for Quality Assurance QA Jobs.
Director, Quality Assurance - GCP is a Quality Assurance QA Job at Mapp Biopharmaceutical located in San Diego CA. Find other listings like Director, Quality Assurance - GCP by searching Oodle for Quality Assurance QA Jobs.