Ed/Vp, Quality Assurance

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Description

Executive Director/VP of Quality Assurance (ED/VPQA) will lead the overall Quality organization in the areas of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP); collectively referenced as GxP. The ED/VPQA will lead the maturation of the quality management systems (QMS) and partnerships with the Company's CDMOs/CROs/CTLs and service providers. Will assure compliance to all applicable regulations and represent Quality Assurance in interdepartmental teams, projects, and meetings with external partners.

The ED/VPQA is responsible for maintaining and enhancing the company Quality Systems related to training programs, GxP document control, clinical development, clinical site activities, non-clinical activities, production of clinical materials, and material testing; with an eye towards future commercialization. This position is the overall thought leader for Quality with a focus on driving quality & regulatory compliance activities for drug development, API/drug product production, and analytical activities.

Specifically, The ED/VPQA is responsible for ensuring that investigational materials and drug products are manufactured, tested, analyzed, packed, and released for use in non-clinical and clinical trials in accordance with industry best practices and respective regulatory requirements and/or registered approvals and in compliance with the principles of cGMP. The ED/VPQA is also responsible for assuring that clinical and non-clinical studies are managed and performed in accordance with the applicable GCP and GLP regulations. In addition, the ED/VPQA is responsible for oversite of suppliers, contract development manufacturing organizations (CDMOs), contract research organizations (CROs), and contract testing laboratories (CTLs) through GxP investigations and audits to ensure regulatory compliance.

• Support the continuous improvement of the Quality Management System related to document development, review, and approval as applicable to ensure GxP compliance is achieved and maintained (i.e. SOPs, complaints, deviations, investigations).

• Assure batch record review and release is performed in an efficient and timely manner.

• Assure quality events, deviations, and other non-conformances are properly investigated, explained, and documented.

• Assure root cause analysis of quality events, deviations, and other non-conformances are performed thoroughly and appropriate CAPAs are initiated.

• Assure the processing and management of change controls is performed in a timely fashion and consistent with the stage of product development.

• Review drug product regulatory dossiers for conformance to source documents.

• Assess and support GxP compliance for clinical studies, non-clinical studies, API/drug product manufacture, and GxP analytical topics (validation and transfer of analytical methods, setting of analytical specifications for the product filing(s)) to maintain compliance with the applicable GxP regulation as required by regulatory filings as well regional or national laws and guidelines. This includes:

• Review and approve protocols, reports, test methods and specifications.

• Conduct or oversee audits of clinical sites, CROs, CDMOs, CTLs, and other service providers as necessary.

• Conduct, review, and/or approve GxP related documentation.

• Verify development activities are coordinated and conducted in accordance with cGxPs, company SOPs, methods, and protocols.

• Represent Quality Assurance in cross-functional clinical development program teams and meetings with CDMOs, CROs, CTLs, and other service providers.

• Develop and manage the Quality organization's annual budget.

• Manage interdepartmental Quality matters and provide Quality related guidance to other departments.

• Manage and provide opportunities for growth for the members of the Quality Team.

Requirements

• Bachelor's degree or higher in a scientific discipline.

• Practical experience of at least 20 years in the pharmaceutical/biopharmaceutical industry, including 15 years of direct QA experience and 10 years supervisory experience in the QA environment; equivalent combination of advanced degree and less experience will be considered.

• Good practical working knowledge of FDA & EU (EMA, MHRA) regulations & cGxPs.

• Experience working with API production and a variety of drug product dosage forms, including solid and liquid oral and aseptically processed injectable drug products.

• Good working knowledge in the analytical space. Good understanding of analytical method validation, pharmaceutical drug substance/drug product analytical technique and microbiological testing requirements.

• Good working knowledge of the drug product development process and clinical/non-clinical study design and performance.

• Experience working with contractors and with developing/managing Quality Technical Agreements (QTAs)

• Experience performing evaluation, selection, maintenance, and for-cause audits of vendors (CDMO, CRO, CTL) and other service providers.

• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided.

• Excellent interpersonal, communication, writing, technical and problem-solving skills.

• Strongly preferred candidate with experience with FDA , MHRA, and EMA inspections, approvals, and guidances, including but not limited to site inspections, manufacturing, and registration inspections

• Strong analytical knowledge and experience