Director/Sr. Director (Head) of Quality Assurance

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.

• BS required, MS preferred in a scientific/technical discipline with 15+ years of experience in a quality leadership position within the biological and/or pharmaceutical industry with specific experience in cell and gene therapy preferred.
• Significant experience supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred.
• Demonstrated experience with writing/reviewing deviations, laboratory investigations, and OOS investigations. Experience with root cause analysis a plus.
• Demonstrated experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
• Solid knowledge of FDA and EMA regulatory requirements for gene therapy and cell therapy
• Ability to apply cGMP regulations and international guidelines to all aspects of the position.
• Ability to write reports, business correspondence, and procedure manuals.
• Proven track record of successfully leading Quality initiatives and driving compliance in a regulated manufacturing environment.
• Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively present information to employees, top management, public groups, and/or boards of directors.
• Strong leadership and people management skills, with the ability to inspire and develop high-performing teams.
• Must be able to assess and utilize software and customized programs to meet QA and QC business needs.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and levels of the organization.
• Strategic mindset with the ability to translate business objectives into actionable Quality strategies and initiatives.

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.