What are the responsibilities and job description for the Director / Sr. Director (Head) of Quality Assurance position at Epicrispr Biotechnologies?
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.
Epicrispr Biotechnologies is seeking a highly motivated Director / Sr. Director (Head) of Quality Assurance.
This position requires ambition, adaptability, and a team-oriented mindset, but also a strong ability to organize parallel projects and work independently to develop a strong quality infrastructure.
Position Summary
The Director / Senior Director of Quality will oversee all quality aspects of the organization from Quality Assurance to Quality Control. The ideal candidate will define and implement the Quality Management System (QMS), including all quality policies and procedures pertaining to the cGMP manufacturing of products for the biotechnology industry. This position will be responsible for the overall implementation and compliance of the Quality Management System, while simultaneously working cross functionally with business and operational functions to successfully deliver on our customer commitments. The Director / Sr. Director of Quality will manage with a strong sense of quality ownership, strategic thinking, creative thinking, and the drive to identify quality problems and develop effective and practical solutions while ensuring standards are achieved through continuous improvements.
Responsibilities :
This position requires ambition, adaptability, and a team-oriented mindset, but also a strong ability to organize parallel projects and work independently to develop a strong quality infrastructure.
- Lead and oversee the Quality function for the company, ensuring compliance with regulatory requirements and industry standards.
- Develop and implement a comprehensive Quality strategy aligned with business objectives, regulatory requirements, and industry best practices.
- Act as the primary GCP and GMP QA subject matter expert and point of contact for all GCP / GMP related matters and issues.
- Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines.
- Prepare, communicate, and manage budgets and goals for the Quality Assurance unit.
- Supervise and guide internal audits of various departments / processes.
- Write, revise, review and / or approve SOPs, controlled forms, and related documents to ensure best practices and current operations.
- Responsible for completing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.
- Address observations or recommendations as well as implement corrective / preventive actions as needed.
- Prepare and approve quality agreements.
- Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements in accordance with company policy.
- Provide mentorship, guidance, and support to Quality Assurance and Quality Control team members, fostering a culture of learning, collaboration, and continuous improvement.
- Drive cross-functional collaboration and alignment with other departments, such as Manufacturing, Regulatory Affairs, and Clinical Operations, to achieve quality and compliance objectives.
- Adhere to company safety requirements. Maintains a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
Qualifications The requirements listed below are representative of the knowledge, skill, and / or ability required to perform this job successfully.
Compensation : The salary range for this position is $176,000 to $285,000 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.
Salary : $176,000 - $285,000