Manager, QA Operations

The Manager, Quality Assurance (QA) Operations ensures compliance with the quality system's procedures and assesses regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices. This role is accountable for routine Quality Assurance duties related to the production and disposition of products manufactured and tested on behalf of Neogene. This role is based in Santa Monica, CA, and reports to the Director of Quality.

What you will do:

• Provide quality assurance support across departments (Manufacturing, Supply Chain, QC, Process Development, Regulatory Affairs) within Neogene and externally to assure compliance and relationships.

• Perform several activities to ensure compliance with applicable quality goals and regulatory requirements.

• Batch documentation ensures resolution of issues to release product.

• Approval of Deviations and CAPAs Support the Disposition of products for the U.S. and other countries.

• Support New Product Introductions.

• Support quality assessments of internal operations to analyze quality compliance and assess risk.

• Provide QA guidance on product development projects and technical transfer activities

• Support Management Review activities and oversee trending of important quality, product, and GMP metrics.

• Support regulatory inspections, internal audits, and external audits from partners.

• Develop QA Standard Operating Procedures to ensure Quality goals are met

• Review routine manufacturing and quality control data for in-process and finished product.

• Develop solutions to more complex problems.

• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.

Minimum Qualifications:

• Bachelor's degree with a minimum of 7 years of experience OR Master's Degree and a minimum of 5 years of experience OR PhD with a minimum of two(2) years experience in a GMP environment.

• Knowledge of and ability to apply GMP in conformance to US, EU, and ROW standards.

• Proficient in cGMP regulations, quality systems, and regulatory requirements.

• Experience writing, evaluating, and closing investigations, CAPAs and change control records.

• Experience conducting internal and external audits.

• Experience supporting Quality Control Analytical and Facilities & Engineering teams.

• Will to accept temporary responsibilities outside of the initial job description.

• Ability to build collaboration amongst individuals.

• Proficient in MS Word, Excel, PowerPoint, and other applications.

• Willingness to think outside of the box and adapt best practices for stage-appropriate products.

• Demonstrate organizational, prioritization, and proficiency.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $95,446 to $119,308. However, base pay may vary depending on multiple individualized factors, including market location, and job-related experience. If hired, the employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

• Short-term incentive bonus opportunity

• Equity-based long-term incentive program

• 401(k) plan

• Paid vacation and holidays; paid leaves

• Health benefits include medical, prescription drug, dental, and vision coverage.

Date Posted

Closing Date