Epicrispr Biotechnologies
Senior Manager, Clinical Quality Assurance
Epicrispr Biotechnologies, San Francisco, California, United States, 94199
Overview
Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that enables safe and persistent control of targeted gene regulation. Our proprietary platform represents a new class of therapeutics for treating severe diseases across multiple areas, including complex diseases influenced by multiple genes. Position Summary
The Senior Manager, Clinical Quality Assurance (CQA) is responsible for ensuring that clinical trials are conducted in accordance with applicable regulatory requirements (e.g., GCP, FDA, EMA, ICH), company SOPs, and industry standards. This individual will lead and support GCP QA activities including audits, inspection readiness, and quality oversight of clinical development programs to ensure the highest standards of quality and compliance. Key Responsibilities
Develop, implement, and maintain GCP compliance programs / procedures and quality systems to support clinical trial execution. Lead and conduct internal and external GCP audits (e.g., investigator sites, CROs, vendors, clinical documentation). Oversee CAPA plans to ensure timely and effective resolution of audit findings and quality issues. Provide QA oversight for clinical development programs, including review of protocols, study reports, and other key clinical documents. Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Therapeutics, CMC and other departments to support study execution and regulatory readiness. Prepare and support regulatory agency inspections (FDA, EMA, etc.), including mock inspections and coordination of responses to observations. Monitor trends and emerging issues in GCP and regulatory guidance to ensure continuous improvement and proactive compliance. Train and mentor company staff on GCP and contribute to GCP training programs across the organization. Lead or contribute to QA projects that enhance quality culture and process efficiency across clinical development. Qualifications
Bachelor’s or advanced degree in life sciences, pharmacy, nursing, or a related field. Minimum 8+ years of relevant experience in Clinical Quality Assurance, including 3+ years in a leadership or managerial role. In-depth knowledge of ICH-GCP, E6-R3 guidelines, FDA, EMA and other relevant international regulatory requirements. Experience conducting clinical site, vendor, and system audits. Proven experience in inspection readiness and participation in regulatory inspections. Strong project management, problem-solving, and interpersonal skills. Ability to work independently in a fast-paced, matrixed environment. Excellent communication and writing skills. Certification (e.g., RQAP-GCP) preferred. Preferred Attributes
Experience with global clinical trials and working in multinational environments. Prior experience in biotech, pharmaceutical, or CRO settings. Familiarity with electronic systems (eTMF, EDC, QMS, Veeva Vault, etc.). Lean or Six Sigma training is a plus. Compensation
The base pay range for this position is $160,000 - $180,000 USD annually. This range is an estimate; actual salary may vary based on factors including education, experience, tenure, skills, and internal equity and market considerations. Equal Employment Opportunity
Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that enables safe and persistent control of targeted gene regulation. Our proprietary platform represents a new class of therapeutics for treating severe diseases across multiple areas, including complex diseases influenced by multiple genes. Position Summary
The Senior Manager, Clinical Quality Assurance (CQA) is responsible for ensuring that clinical trials are conducted in accordance with applicable regulatory requirements (e.g., GCP, FDA, EMA, ICH), company SOPs, and industry standards. This individual will lead and support GCP QA activities including audits, inspection readiness, and quality oversight of clinical development programs to ensure the highest standards of quality and compliance. Key Responsibilities
Develop, implement, and maintain GCP compliance programs / procedures and quality systems to support clinical trial execution. Lead and conduct internal and external GCP audits (e.g., investigator sites, CROs, vendors, clinical documentation). Oversee CAPA plans to ensure timely and effective resolution of audit findings and quality issues. Provide QA oversight for clinical development programs, including review of protocols, study reports, and other key clinical documents. Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Therapeutics, CMC and other departments to support study execution and regulatory readiness. Prepare and support regulatory agency inspections (FDA, EMA, etc.), including mock inspections and coordination of responses to observations. Monitor trends and emerging issues in GCP and regulatory guidance to ensure continuous improvement and proactive compliance. Train and mentor company staff on GCP and contribute to GCP training programs across the organization. Lead or contribute to QA projects that enhance quality culture and process efficiency across clinical development. Qualifications
Bachelor’s or advanced degree in life sciences, pharmacy, nursing, or a related field. Minimum 8+ years of relevant experience in Clinical Quality Assurance, including 3+ years in a leadership or managerial role. In-depth knowledge of ICH-GCP, E6-R3 guidelines, FDA, EMA and other relevant international regulatory requirements. Experience conducting clinical site, vendor, and system audits. Proven experience in inspection readiness and participation in regulatory inspections. Strong project management, problem-solving, and interpersonal skills. Ability to work independently in a fast-paced, matrixed environment. Excellent communication and writing skills. Certification (e.g., RQAP-GCP) preferred. Preferred Attributes
Experience with global clinical trials and working in multinational environments. Prior experience in biotech, pharmaceutical, or CRO settings. Familiarity with electronic systems (eTMF, EDC, QMS, Veeva Vault, etc.). Lean or Six Sigma training is a plus. Compensation
The base pay range for this position is $160,000 - $180,000 USD annually. This range is an estimate; actual salary may vary based on factors including education, experience, tenure, skills, and internal equity and market considerations. Equal Employment Opportunity
Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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