Senior Manager, Clinical Quality Assurance (CQA)

Who Are We?

Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. 

We are looking for exceptional team members who want an active role in building a rapidly growing biotech.

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 salary range for this position is $$160,000 to $180,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.

Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants for employment 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.