Quality Manager - 21986 in San Diego

Quality Manager – Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company? Then we have the right team for you! In this role, you are responsible for the duties listed below.

QUALIFICATIONS

Immediate opening for a Quality Manager in San Diego, CA who possess: Bachelor’s Degree in a Scientific Discipline 5+ years of direct pharmaceutical experience within QA & QC 2+ years of experience in a quality management role Familiarity with MasterControl and other relevant quality software Email resumes to View email address on click.appcast.io and call View phone number on click.appcast.io.

FULL DESCRIPTION

The Site Quality Manager for the San Diego office is responsible for overseeing all aspects of quality related matters to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the Company’s policies. The position requires a strong background in Quality Assurance (QA), chemistry, or microbiology, and experience in aseptic manufacturing. In addition to ensuring compliance with industry standards this role is responsible for leading quality improvement initiatives at the site and assuring that the site is capable of supplying products of high quality and value in a timely manner.

QUALITY OVERSIGHT

Direct oversight of the Quality Assurance and Quality Control groups. Manage all product release activities, ensuring compliance with regulatory standards. Oversee the site supplier qualification and auditing program. Ensure all aspects of the handling, manufacturing, and distribution of products at the site comply with the requirements of the corporate quality manual, relevant quality agreements or policies, and meet all relevant GMP regulatory and legislative requirements. Provide general management oversight for Quality at the site as directed by the Vice President, Quality, US. Manage the quality relationship with any customer for whom we contract manufacture, ensuring clear communication, adherence to quality agreements, and satisfaction of their quality standards and requirements.

QUALITY SYSTEM MANAGEMENT

Ensure local quality system and standard operating procedures are in place and that compliance with cGMP is maintained through training and audit. Ensure high product quality through qualification and validation based on quality risk analysis. Ensure the QA department operates cost‑effectively and efficiently, maintaining an innovative approach based on productivity improvement, best practice implementation, and harmonization with technical operations.

PROJECT LEADERSHIP

Lead and report on various quality improvement projects within the quality, laboratory, and manufacturing areas. Facilitate regulatory agency inspections (e.g., FDA) and customer audits. Together with management, provide direction, formulate strategies, and make decisions ensuring the efficient operation of the site as a whole.

INVESTIGATIONS AND REPORTING

Lead quality investigations on an as‑needed basis, providing expert analysis and resolution. Author the Annual Product Quality Review (APQR) for the site. Ensure on‑time completion of required reports, such as CAPA (Corrective and Preventative Actions) and Deviation reports.

OPERATIONAL SUPPORT

Provide necessary QA oversight during site media fills. Offer input and support for site validation activities. Assist in developing and monitoring the site QA/QC financial budgets. Ensure all components, drug product containers, closures, in‑process materials, packaging material, labels, and drug products are released in accordance with the registered specifications. Responsible for timely implementation of safety, security, industrial hygiene, and ecology regulations in all parts of the QA department.

STAFF DEVELOPMENT

Train and develop staff within QA and QC groups. Provide leadership, direction, and support to QA department personnel, ensuring they are qualified, achieve a high level of competence, are motivated, and carry out their duties safely.

EDUCATION REQUIREMENTS

Baccalaureate degree in a scientific discipline such as Chemistry, Microbiology, or a related field.

SKILLS AND WORK EXPERIENCE REQUIREMENTS

Minimum of 5 years of direct pharmaceutical experience within QA, chemistry, or microbiology; with preference to aseptic manufacturing experience. Proven leadership experience in a quality management role. Proficient in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint, Access, Project). Familiarity with Adobe Acrobat. Knowledge of QlikView, Master Control, MODA, and LIMS software programs. Salary Range: $125‑130k/year For immediate and confidential consideration, please email your resume to View email address on click.appcast.io and call View phone number on click.appcast.io. More information can be found at #J-18808-Ljbffr Energy Jobline ZR