Associate Director/Director, Quality Systems
Eleven Biotherapeutics, Inc. (EBI) is looking for a talented leader to create and lead the Quality function. This position reports to the Chief Development Officer and will be responsible for the strategic oversight and management of the Quality systems in compliance with worldwide regulations and guidance.
- Partner with the senior members of the clinical and CMC staff to develop plans for quality oversight;
- Lead the development and execution and oversight of the overall quality strategy through risk assessment and planning;
- Ensure compliance to applicable regulatory and quality SOPs and and other regulatory agency guidance rulings;
- Responsible for the application of quality systems necessary for the manufacture and release of clinical active pharmaceutical ingredient (API) and drug product (DP) and labeled clinical trial material;
- Conduct and/or supervises audits (GxP);
- Audit/review regulatory GLP and cGMP submissions for accuracy and completeness;
- Ensure inspection readiness and represent the company during FDA GLP & cGMP-related inspection;
- Oversee corrective actions that are outcomes of GxP quality audits;
- Identify ongoing risk assessment and collaboration with internal stakeholders;
- Manage external stakeholders including contract CROs and auditors and audits of investigator sites, vendors, commercials IRBs, database and pharmacovigilance;
- Responsible for the generation, review and reporting of audit metrics;
- Point of contact for compliance advice for product clinical teams;
- Provide quality support and oversight for key functional areas operating within the clinical, non-clinical and chemistry manufacturing and controls (CMC);
- Responsible for the application of quality systems necessary for the manufacture and release of clinical active pharmaceutical ingredient (API) and drug product (DP) and labeled clinical trial material.
- B.S. plus 8 years experience with at least 2 years in a management role
- An understanding of the how to effectively develop, implement and support a GxP program;
- Demonstrated knowledge of current US and European GMP and GLP regulatory requirements;
- Strong knowledge of GCP quality system requirements for clinical and commercial products;
- Experience managing GMP/GLP regulatory inspections and presenting to regulatory inspectors;
- Strong problem solving and risk based decision making skills;
- Excellent communication and influence skills with the ability to work across multiple cross-discipline functions; and
- Previous experience working with contract manufacturing strongly preferred.
About Eleven Biotherapeutics
Eleven Biotherapeutics is a clinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. The company’s therapeutic approach is based on the role of cytokines in diseases of the eye, the company’s understanding of the structural biology of cytokines and the company’s ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects.
For consideration, please send your resume to firstname.lastname@example.org
Please, no third party solicitation.