Position Summary

The Director Quality is responsible for ensuring compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and regulations and company practices/standards. This role is accountable for routine Quality Assurance duties related to the production and disposition of products manufactured and Quality Control tested by or on behalf of Neogene. Responsible for oversight of development, implementation, maintenance and performance of the Quality Assurance systems and programs. This role is based in Santa Monica, CA, and reports to Sr. Director, Quality in NL. This position is a fulltime role and offers the option for a hybrid work arrangement.

Essential Functions and Responsibilities

• Lead and management of QA and QC teams for all US- Neogene sites.
• Drive strategy and roadmap in support of the company's Quality Vision.
• Ensure quality assurance support across functions within Neogene (e.g., Manufacturing, Supply Chain, QC, Process Development, Facilities and Engineering, Analytical Development, Clinical Development, Regulatory Affairs) and externally to assure compliance and strong relationships.
• Perform a wide variety of activities to ensure compliance with applicable Quality objectives and global regulatory requirements.
• Authoring, review and/or approval of GxP records and documents (both internal and external) including but not limited to master and executed production batch records, deviations/investigations, corrective actions, change controls, protocols and reports.
• Provide guidance, support and oversee all activities related to product disposition and new product introductions.
• Ensure quality systems, processes, specifications, and SOPs are designed to be appropriate for the development, manufacture, testing, timely release and distribution of product, and meet all relevant regulatory requirements, and are consistent with the global Quality strategy.
• Authoring/reviewing of CMC sections of global regulatory submissions.
• Provide QA guidance on product development projects, technical transfer activities and on developing solutions to more complex problems.
• Support Management Review activities and oversee trending of key quality, product and GMP metrics.
• Support regulatory inspections, internal audits, and external audits from partners.
• Design, effective implementation, monitoring and maintenance of the Quality Management System for GMP.
• Reviews routine manufacturing and quality control data for in-process and finished product.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Perform other duties as assigned.

Supervisory Responsibilities

• Leading QA/QC team and day-to day supervision of onsite employees.

Required Skills/Abilities

• Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Self-motivated, detail-oriented, and willing to accept responsibilities outside of initial job description.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Willingness to think outside of the box and adapt best practices for stage appropriate products.
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Education and Experience

• Bachelor's Degree and a minimum of twelve (12) year's experience OR Master's Degree and a minimum of ten (10) year's experience in a GMP environment.
• Experience in writing, evaluating, and closing investigations, CAPAs and change control records.
• Experience with conducting and managing internal and external audits.

The anticipated salary range for candidates who will work in Santa Monica, CA is $170,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

At this time, Neogene is not sponsoring VISAs.

Neogene Therapeutics requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.