Careers in Quality

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.
• 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.

About Auro Vaccines, LLC

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 parent company is Aurobindo Pharma USA, Inc. Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients.  Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes.  Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of ...the top 100 most prescribed products in the world.  In past years, Aurobindo has received more ANDA approvals than any of our competitors.  Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010)

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