Quality Assurance SME

Background: A Quality Assurance Subject Matter Expert (Quality Systems and GxP) is needed to provide contracted staffing support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. BARDA's mission is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. For more information on BARDA please visit their official website.

https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx and specifically the Division of Regulatory and Quality Affairs:  https://medicalcountermeasures.gov/barda/rqa

Essential duties and responsibilities include but are not limited to the following. Other duties may be assigned:

• Serve as a source of general quality guidance and as a technical resource for quality issues and compliance issues.
• Review and evaluate documentation related to Quality Management Systems, Quality Agreements, quality documents, development plans, development study reports, study protocols.
• Review development activities and documentation to ensure products meet specifications, are produced and tested in compliance with approved procedures and applicable regulations/industry standards.
• Assist in Quality investigations of GMP activities as subject matter expert (SME).  Provide assessments of recommended corrective and preventative actions; ensure implementation of corrective and preventative actions.
• Audit function:  Lead, support, and participate in auditing activities, including supplier audits, contractor audits, manufacturing site audits, and regulatory inspections.  Evaluate responses to audit findings for adequacy.  Ensure timely and effective close-out of corrective and preventative actions.
• Serve as 'man in the plant' as required.
• Support development, organization, maintenance of SOPS, internal quality documentation, files, records and quality databases.

Education:

• BS. or M.S. in life sciences or related field.

Requirements:

• Recognized Quality expert with minimum of 10 years progressive experience in drug development, manufacturing environment with extensive experience in regulatory compliance and auditing in cGMP regulated industry.
• Skilled in developing, implementing, managing, and integrating Quality Management Systems for drug and biologic development and manufacture. Experience with device and/or IVD development, including FDA Quality Management System Regulation, 21 CFR Part 820, ISO 13485, and related quality system requirements, is a plus.
• Experienced in the development of manufacturing processes for drugs and biologics with a strong ability to effectively interact with diverse teams to identify opportunities to improve quality and resolve quality/compliance issues.
• Solid knowledge of FDA, EMA and ICH cGMP requirements regarding cGMP for clinical supplies and final products supported by a broad expert knowledge base in all GXPs. Must be able to interpret and apply regulations and guidance independently with understanding of the approach and perspectives of regulatory agencies. Familiarity with GCP as related to execution and compliance monitoring of clinical trials is desirable.
• Experience performing supplier, contractor, manufacturing site, and product acceptance audits in a regulated GxP environment.
• Audit certification, such as ASQ Certified Quality Auditor, or CQA, is preferred. Equivalent formal auditor training and demonstrated experience leading GxP, cGMP, supplier, contractor, manufacturing site, or product acceptance audits may be considered. Additional relevant certifications, such as ASQ Certified Pharmaceutical GMP Professional, ASQ Certified Medical Device Auditor, ISO 13485 Lead Auditor, RQAP-GCP, RQAP-GLP, or RAC-Drugs/RAC-Devices, are a plus.
• Expertise in validation and operation of cGMP manufacturing facilities.
• Willingness and eagerness to work in a hands-on capacity.
• Ability to work both independently and in a collaborative team setting and successfully build relationships with internal teams.
• Demonstrable track record managing projects of significant scope and complexity while meeting all deliverables and timelines.
• Excellent verbal and written communication skills.  Ability to effectively present information to management.
• Ability and willingness to travel, as required, to conduct and support audits, site visits, manufacturing oversight, product acceptance activities, and related quality/compliance engagements.

Must be a US Citizen or full Green Card holder.