Director/Sr Director, Quality Assurance

Escient is seeking a dynamic, creative and highly motivated individual for the position of Director/Senior Director to lead, develop, and manage all aspects of quality assurance and training programs within the company to ensure all Gx-P-related activities (GCP, GMP and GLP) are conducted according to appropriate internal and external quality standards, including those regulated by the FDA and other relevant authorities. 

The ideal candidate must be able to work in a fast-paced environment with drug development professionals and be able to respond to changing priorities in a thoughtful, creative manner.  

Primary responsibilities include: 

Leading and directing the implementation of QA policies and procedures to ensure cohesive and consistent quality plans are executed 

Developing and maintaining the QMS, including quality processes and audit activities within Escient facilities and externally with 3rd party suppliers/external vendors (CDMOs) to ensure each operate in accordance with all relevant regulatory standards and remain compliant and held accountable to such standards 

Overseeing the GMP compliance of manufacturing and production related operations 

Identifying potential areas of compliance vulnerability and risk; developing and implementing corrective action plans for resolution to ensure conformity with regulatory commitments and regulations 

Acting as primary lead during inspections. Prepare facilities and staff for successful inspections and product approvals by relevant regulatory agencies. 

Establishing and promoting a culture of compliance, adherence to processes, and documentation to ensure successful product development  

Leading the development of company training programs for GxP-related procedures, practices, and system requirements 

Providing metrics on a periodic basis to update senior leadership of the operation and progress of quality and compliance efforts  

Leading and building the quality assurance team in pursuit of department objectives; provide coaching and support as needed 

Developing and managing department budget 

Ensuring appropriate audits across sites to ensure compliance to include pre-audit preparation with all development and/or manufacturing sites. Evaluate and follow up on the appropriateness and completeness of corrective actions plans. 

Responsible for complaint handling system, including procedures, investigations, and responses  

Assisting in regulatory CMC submissions 

Remaining current with quality management trends. Review and interpret new regulations and ensure that quality systems evolve appropriately. 

Participate in and represent QA in project meetings and discussions as needed 

Providing GMP hands on expertise for internal and external manufacturing and distribution programs and assist with the quality oversight of GMP activities including material receipt, intermediate and bulk drug product manufacture, packaging and labeling, and batch review and disposition. 

Providing phase appropriate technical quality expertise throughout all phases of drug development for the management of internal and external Contract Testing Laboratories, e.g., QC activities, including: 

QC Oversight of CMO/CTOs (CXO Liaison) 

Method Development and qualification, validation, and technology transfer of assays 

Stability and Reference Standard Program Development/Management 

EDUCATION AND QUALIFICATIONS 

• Bachelor’s degree in life sciences, chemistry, or engineering. Master’s or PhD preferred. 
• A minimum of ten years of relevant industry experience in quality assurance in support of clinical research, product development, regulatory affairs and/or regulatory compliance 
• Direct or supervisory experience in GXP auditing/compliance experience 
• Strong working knowledge of applicable regulations, guidelines, and industry standards (i.e., ICH-GCP, GLP, and GMP guidelines, FDA, EMA and other international Quality Systems regulations and standards 
• Knowledge of pharmaceutical/biotechnology process and auditing practices 
• Successful executed efforts to drive efficiency in Quality operations 
• Experience in establishing QA standards with respect to operations, product development, R&D, and manufacturing 
• Direct experience with interacting with US regulatory authorities for pre-approval inspections 
• Experience working with QA at CDMOs and managing third party contract facilities 
• Experience in emerging (clinical-development stage) and commercial-stage pharmaceutical companies 
• Travel will be required to the extent necessary for regulatory and specific quality assurance meetings (anticipated 5-15%). Attendance at relevant professional conferences is encouraged.  

Escient Pharmaceuticals, Inc.’s Human Resources team manages its own recruitment and employment process. To protect the interest of all parties involved, Escient will only accept resumes from a recruiter if an executed search agreement is in place at the start of the recruitment effort for a particular open position. Unsolicited resumes sent to Escient from recruiters do not constitute or create any type of relationship between the recruiter and Escient, and Escient shall not pay any fees should we hire any individual from those resumes. Recruiters are requested not to contact or present candidates directly to Escient’s hiring manager or employees.