• Direct the Quality compliance requirements of Emergent Product Development Gaithersburg


• Develop and implement Quality Systems and infrastructure appropriate for product development and in compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) regulatory requirements.


• Manage the Quality Assurance (QA) department to effectively assure Quality requirements for the supply and testing of Emergent products from pre-clinical testing through BLA submission and monitor compliance for the management and conduct of clinical trials.


• Ensure Quality operations employed at EPDG are aligned to EBS corporate practices


• Manage the document control function ensuring all documentation is appropriately controlled and archived

Major Responsibilities include but not limited to:

-          Establish a Quality Assurance Unit at EPDG appropriate to addressing all Quality requirements for product development and ensure effective implementation of quality practices on site

-          Provide oversight and direct the Quality resources at EPDG to ensure appropriate support and compliance of all development projects and operations at EPDG

-          Host regulatory audits at EPDG, serve as a lead auditor for EPDG or oversee regulatory audits at third party facilities where required

-          Oversee the review, and approval of deviations, investigations and violations affecting Development, and approves corrective action recommendations and final conclusions

-          Coordinate and/or conduct audits and reviews of technical, pre-clinical and clinical study reports and regulatory submissions to ensure appropriate quality for the intended purpose

-          Coordinate and support Corporate Compliance, as necessary,  in conducting QA audits of potential clinical and non-clinical trial sites,, clinical databases, clinical study reports, clinical study files and Contract Research Organizations  and ensure they are appropriately evaluated for suitability, and audited in compliance with GLP when appropriate

-          Coordinate and support Corporate Compliance, as necessary,  in conducting QA audits of potential manufacturing sites and ensure they are appropriately evaluated for suitability, and audited in compliance with cGMP

-          Ensure that Clinical Supplies are manufactured, packaged and tested according to appropriate quality standards, procedures and regulations.

Requirements:

Bachelors in Chemistry, Biochemistry, Biology, Microbiology or related science discipline. 10-12 years of QA or Compliance experience supporting GMP. GLP, and/or GCP operations in biologics industry; previous management experience required; 3-5 years experience conducting compliance auditing required. Working knowledge of GMPs, GLPs, GCPs and ICH guidelines. Ability to lead projects with minimal supervision required.