Quality Assurance Manager

We are excited to offer a unique and rewarding career opportunity for a motivated and experienced Quality Assurance Manager to join Antharis Therapeutics, a cutting-edge pre-clinical company in San Diego. Antharis is dedicated to discovering and developing novel immunotherapeutics, including monoclonal antibodies and antibody-drug conjugates, aimed at treating a wide range of disease states. Our innovative approaches, including hybridoma technology, are designed to accelerate the development of lead candidates for rapid clinical advancement.

We seek a Quality Assurance Manager with proven expertise in antibody discovery, specifically utilizing hybridoma technology. The successful candidate will be responsible for designing and executing immunization and screening strategies to generate diverse panels of antibodies targeting key proteins in oncology and immuno-oncology. In-depth knowledge of the latest advancements in antibody generation technologies is essential, along with the ability to apply these practices at the bench.

This role offers an excellent opportunity to contribute to groundbreaking therapeutic developments while ensuring the highest quality and compliance standards.

Essential Job Functions:

·       Lead the development, implementation, and continuous improvement of quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards.

·       Initiate, manage, and investigate nonconformances and corrective and preventive actions (CAPAs), coordinating necessary activities across departments and external parties.

·       Monitor and manage the effectiveness of quality systems, including deviations, investigations, and CAPAs, utilizing data trending to identify areas for improvement.

·       Ensure final products meet established specifications and end-user expectations by reviewing quality control (QC) data and adjusting product specifications.

·       Act as the subject matter expert (SME) for Quality and Compliance in product development, process characterization, validation, and GMP (Good Manufacturing Practice) activities.

·       Oversee and participate in internal assessments, audits, and regulatory inspections to maintain compliance with applicable regulations and standards.

·       Drive continuous improvement initiatives by implementing best practices, new systems, and process changes to enhance the Quality Assurance function.

·       Develop and revise Standard Operating Procedures (SOPs) and other CGMP documentation to support risk assessments, process validation, and product comparability studies.

·       Manage the GMP Quality System for product development, from clinical phases to commercial manufacturing, ensuring adherence to quality standards.

·       Provide oversight and QA input on risk management activities, regulatory submissions, and GMP facility, equipment, and method qualifications.

·       Ensure effective IT quality processes are in place and provide guidance on compliance with regulatory requirements.

·       Monitor regulatory requirements and industry trends, conduct gap analyses, and implement necessary changes to maintain the Quality System’s compliance.

·       Manage GMP training programs, ensuring they cover all relevant regulatory requirements and are implemented effectively.

·       Track and analyze key performance indicators (KPIs) related to quality systems, escalating issues and risks to senior management as needed.

·       Manage and oversee GMP activities performed by third-party vendors, ensuring compliance with internal and external standards.

·       Work collaboratively with cross-functional teams to ensure timely, high-quality completion of projects aligned with scientific and regulatory standards.

·       Hire, train, coach, and develop Quality Assurance specialists, providing leadership and oversight of their activities.

·       Perform additional duties as required.

Qualifications:

• Minimum of 5 years of experience in a Quality Assurance role, with at least 7 years of relevant experience in the biotech, pharmaceutical, or IVD (in vitro diagnostics) industries leading projects, systems, and personnel.
• Advanced knowledge of manufacturing processes and procedures in the biotech or sequencing industry, including acceptance activities, production and process controls, traceability, and quality auditing.
• Proven ability in writing procedures, protocols, and reports and driving investigations to root cause.
• Bachelor's degree in life sciences (e.g., Chemistry, Biology, Microbiology, Biochemistry), pharmacy, or a related engineering field.
• Relevant certifications (e.g., ASQ, SQA, ISO) are preferred.
• Working knowledge of CGMP requirements for biologics manufacturing, aseptic manufacturing, and basic understanding of cell biology and cell culture.
• Strong problem-solving and analytical skills to proactively identify and address issues with a solution-oriented approach.
• Ability to interpret and apply CGMP requirements effectively, ensuring compliance with regulatory standards.
• Superior organizational skills, with the ability to manage and prioritize multiple projects simultaneously, ensuring timely completion of assignments and meeting deadlines.
• Proven ability to lead teams and work collaboratively within matrix organizations to drive performance and foster partnerships.
• Strong communication skills (both verbal and written) to maintain alignment between internal and external stakeholders.
• Track record of managing performance metrics and improving processes for enhanced quality outcomes.
• Strong drive for quality and continuous process improvement.
• Self-starter with high energy, initiative, and independence, capable of instilling a sense of urgency and pace within the team.
• Demonstrated ability to move fast and make decisions decisively, with a passion for working in a growing company.
• Collaborative and creative mindset, willing to take prudent risks to drive transformative treatments for patients.
• Focus on achieving challenging timelines through superior planning, risk assessment, and inspiring teams to work efficiently.
• Committed to building partnerships and fostering a collaborative work environment, prioritizing company and team success over personal goals.

Benefits:

·       Compensation based on relevant experience, skill set, and market factors.

·       401(k) plan with employer match.

·       Comprehensive wellness program, including medical, dental, and vision coverage.

• ·       Unlimited time off policy.