RQA Quality Assurance Subject Matter ExpertBookmark This
RQA Quality Assurance Subject Matter Expert
We have a long term contract opportunity available for one of our U.S. Federal Government clients located in Washington, DC. A Quality Assurance Subject Matter Expert is needed to provide advice, program management (PM) support, and mentorship to a government agency. The mission of this federal agency is to develop medical countermeasures to various Chemical, Biological, Radiological, and Nuclear (CBRN) threats, Influenza and emerging diseases. The successful candidate will work closely with government and contractor personnel to implement quality initiatives, perform audits and support product development teams composed of non-clinical, clinical, regulatory, CMC, manufacturing and project management experts. This candidate will apply quality assurance principles and practices across the portfolio of pharmaceutical product development and late stage manufacturing efforts within the organization.
Position Responsibilities: 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 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.
- Recognized Quality expert with minimum of 20 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. Device/IVD development and experience with the Quality System Regulations 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.
- Skilled auditor with experience in compliance activities and a proven ability to conduct manufacturing facility/site inspection and audits for regulatory compliance. Ability to support regulatory inspections.
- 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.
- Ph.D. or M.S. in life sciences or related field.