Auro Vaccines LLC is a clinical-stage vaccine development company pioneering a major evolutionary step in the design and development of preventive and therapeutic vaccines for infectious diseases.

The Quality Assurance Manager will be responsible for overseeing and approving cGMP and GCLP/GLP activities conducted internally and by outside contractors as well as measuring and monitoring cGMP Compliance levels at contractor sites through the performance of audits. 

 

The incumbent should also be familiar with the development, implementation, and maintenance of a Quality Management Systems (QMS) supporting the testing of preclinical and human clinical samples. The candidate should be knowledgeable in assay development, qualification and validation of clinical assays, and the qualification/validation of equipment and laboratory instruments. and systems to support vaccine trials, including documentation and reviewer strategies.

 

This candidate is required to work in a team environment or independently to meet defined objectives based on an established timeline and deliver project work in a manner that is consistent with the company’s values.

• Responsible for measuring and monitoring cGMP Compliance levels at contractor sites through the performance of audits. 
• Reviews and approves master batch records, and other supporting cGMP documentation, including, but not limited to QA Agreements, investigations, Out-of-Specification (OOS) results, product development and validation reports. 
• Reviews and approves executed production batch records and provides disposition to CTM materials.  Manages quality investigation activities and other issues or events at CMOs. 
• Directly responsible and accountable for all Quality oversight activities relating to preclinical and clinical assay testing.
• Develop, implement, and maintain a Quality Management System (QMS) that supports the execution of preclinical and clinical assay testing.  This includes a high-level quality manual, and a phase appropriate, incremental road map/plan for implementation of GCLP/GLP, followed by quality system SOPs, forms and other documentation reporting mechanisms.
• Provide quality oversight to the execution of preclinical and clinical assay testing.  This includes, but may not be limited to: review and approval of analytical method SOPS, qualification and validation protocols and reports, as well as analytical instrument and equipment IOQ/PQ and calibration activities; review and approval of laboratory and quality system SOPs; and critical review/audit of immunoassay testing activities.
• Oversee the Clinical Assay Laboratory Analyst GCLP/GLP training programs.  Provide introductory and periodic GCLP/GLP refresher training to Clinical Assay Laboratory personnel.
• Assure a phase appropriate/incremental approach to levels of GCLP/GLP compliance, from preclinical testing through to the testing of samples supporting licensed products.

• Perform other duties as assigned and be cooperative when assigned those additional responsibilities.

• A background in GCLP/GMP and the development, implementation, and maintenance of quality systems supporting these regulated activities. 
• A working understanding of immunological assays, biostatistics, as it applies to the execution of immunoassays, and critical data review and approval is required.
• A working understanding of assay qualification and validation, and the calibration, qualification/validation of laboratory instruments and equipment.
• Must have excellent writing and verbal communication skills, and exhibit attention to detail and accuracy.
• The ability to work in a cross-functional environment with a can-do, hands on, attitude to drive productivity and efficiency is required.  Ability to provide negative feedback to Clinical Assay Laboratory personnel in a positive fashion.
• Able to support Clinical Assay Laboratory Management in troubleshooting technical or regulatory issues or investigations.

 

To protect the safety of our workforce, customers, and communities, the policy of the Company requires all employees and workers in the U.S. to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  All applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. 

• A minimum of a scientific Bachelor’s degree is required with at least 5+ years of experience, and/or advanced degree Master’s or Ph.D. degree with at least 3+ years direct pharmaceutical/vaccine industry experience with clinical testing in a GCLP/GLP environment is preferred.
• Hands on experience with the development, implementation and maintenance of quality systems supporting clinical assay testing in a GCLP/GLP setting.
• Experience in immunoassays, analytical method qualification/validation, and laboratory equipment and instrument calibration, qualification, and validation.
• Ability to review/audit/authorize regulated cGMP activities.
• A background in immunology, microbiology and/or virology are essential.

OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.