Manager, QA Operations - Neogene Therapeutics

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Manager, QA Operations ensures compliance with the quality system's procedures and assessing 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.

Responsibilities

• 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 ensure resolution of issues to release product.
• Approval of Deviations and CAPAs Support Disposition of product for 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.

Education and Experience

• Bachelor's degree with a minimum seven (7) years of experience OR Master's Degree and a minimum five (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 initial job description.
• Ability build collaboration amongst individuals.
• Proficient in MS Word, Excel, Power Point 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 $94,719 to $118,399. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, 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 including medical, prescription drug, dental, and vision coverage.

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.