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.

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

22-Sep-2024

Closing Date

06-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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