Manager, QA Operations

4 days ago

Santa Monica CA United States Neogene Therapeutics Full time

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.

RequiredPreferredJob Industries
  • Other

  • Senior QA Engineer

    6 days ago

    Santa Monica, United States Torpago, Inc. Full time

    Through innovative spend management software, robust card issuing capabilities, and a modular approach, Torpago empowers banks to offer their customers white-labeled, industry-leading business credit card programs. Fresh off of $16mm in new funding, we're looking for a highly motivated Senior Quality Assurance Engineer to join our team. We are seeking an...

  • Senior QA Engineer

    6 days ago

    Santa Monica, United States Torpago, Inc. Full time

    Through innovative spend management software, robust card issuing capabilities, and a modular approach, Torpago empowers banks to offer their customers white-labeled, industry-leading business credit card programs. Fresh off of $16mm in new funding, we're looking for a highly motivated Senior Quality Assurance Engineer to join our team. We are seeking an...

  • Operations Management Lead

    7 days ago

    Santa Monica, California, United States Veo - Operations Careers Full time

    About Veo">Veo is a mission-driven company dedicated to making clean transportation accessible to all.We design, build, and operate fully electric micromobility systems, including e-bikes, e-scooters, and cargo bikes.Our goal is to end car dependency by providing safe, efficient, and responsive mobility services that make communities more sustainable and...

  • QA Manager

    12 hours ago

    Washington, DC, United States CipherStaff Full time

    Direct hire. Seeking senior SQA Manager. Must be US Citizen and/or Greencard holder in order to attain low level clearance. Position is currently hybrid with two to three days on-site in Washington, DC L'enfrant Plaza area. Pay range from $120,000 to $138,000 a year with full benefits but will depend on experience. Bachelor's degree required. Must not have...

  • Senior Security QA

    11 hours ago

    Santa Clara, CA, United States SA TECHNOLOGIES Full time

    All SA Technologies requirements are Direct Client Requirements from IT Hiring Managers. We guarantee you the best rate for your skills and performance. Job Description Position: Senior Security QA Duration: 6 Months+ Key Responsibilities Work closely with Security Development and QA teams. Develop solutions to complex problems. Exercise considerable...

  • QA Engineer

    1 day ago

    Santa Monica, CA, United States Prosum2 Full time

    Contract Company Description Our Client is creator of the nation's most popular in-home fitness and weight loss solutions. They are a Multi-channel Marketer, with mobile, print, online, radio, and various other presences. Offering the most innovative, results-oriented programs and skilled, motivational trainers, their core purpose is to help people achieve...

  • Senior QA Engineer

    1 day ago

    Santa Clara, CA, United States SA TECHNOLOGIES Full time

    All SA Technologies requirements are Direct Client Requirements from IT Hiring Managers. We guarantee you the best rate for your skills and performance. Job Description Duration: 6 Months Key Responsibilities Work closely with Security Development and QA teams. Develop solutions to complex problems. Exercise considerable latitude in determining technical...

  • Senior Learning Consultant

    1 day ago

    New York, NY, United States QA Limited Full time

    Sales - Digital Customer Success & Consultancy Title Contract type QA Ltd Permanent Job advert Location: Remote (with travel) Your role will be the lead subject matter expert in the AI Practice with responsibility for product design and development. You will represent the AI group’s needs for the design of bespoke, off-the-shelf and certification products...

  • QA Testing Engineer

    12 hours ago

    Sunnyvale, CA, United States Redolent Infotech Pvt. Ltd. Full time

    One of our direct clients is urgently looking for a QA Test Engineer @ San Bruno, CA TITLE: QA Test EngineerLOCATION: Sunnyvale, CADuration: 6 to 12+ Months Description: 8+ Years of experience in QA Manual and Automation testing. Experience with Retail / E-Commerce domain is a must. Manual and Automation Testing. Functional, End to End. Test data management,...

  • Sr. QA engineer

    1 day ago

    Santa Clara, CA, United States SA TECHNOLOGIES Full time

    All SA Technologies requirements are Direct Client Requirements from IT Hiring Managers. We guarantee you the best rate for your skills and performance. Job Description Duration: 6 Months+ Rate: Open Principal Duties and Responsibilities Immediate opportunity for a talented Principal Quality Engineer to join a team of software professionals developing the...

  • Sr Quant QA Engineer

    1 day ago

    Pasadena, CA, United States ideaVat Full time

    • Work closely with quantitative developers, financial engineers, and system QA Engineers in transforming quantitative business requirements and use cases into test cases for model validation, functional, regression, and integration testing. • Create, execute, track, and report on model validation, functional, and integration test cases of highly...

  • QA Director

    12 hours ago

    , MA, United States Scilligence Full time

    We are looking for a QA Director to join our Cambridge team in Massachusetts. The primary role of this position is to lead our QA team and optimize our QA processes. Responsibilities: Manage and lead QA team (remote) Optimize our QA strategy that aligns with the company's goals and objectives. Optimize our software testing process, including test planning,...

  • QA Automation Engineer

    1 day ago

    Glendale, CA, United States Prosum2 Full time

    We are a technology services company that puts people before technology. Yes, we have deep experience consulting, implementing solutions, providing managed services and staffing engagements. But we believe that, by focusing on relationships, we are better able to improve people’s experiences and lives through technology. Technology is at its best when it...

  • QA Technician

    3 weeks ago

    Santa Ana, United States Rich Products Corporation Full time

    Rich's, also known as Rich Products Corporation, is a family-owned food company dedicated to inspiring possibilities. From cakes and icings to pizza, appetizers and specialty toppings, our products are used in homes, restaurants and bakeries around the world. Beyond great food, our customers also gain insights to help them stay competitive, no matter their...

  • QA Engineer

    1 day ago

    San Francisco, CA, United States Stitch Fix Full time

    Qualifications You have experience in working on large, cross-functional teams and projects You are an expert in agile methodology, QA tools/systems, have a deep understanding of ERP/transactional systems like Oracle Cloud and other financial systems You love to launch and lead the QA practice for enterprise applications You love to work in a hyper growth...

  • System QA Manager

    6 days ago

    Suffern, NY, United States WMC Health Network Full time

    The System QA Manager is responsible for creating and maintaining the laboratory's Quality plan that will be compliant with CLSI, CAP and NYSDOH standards for all hospital locations within the Bon Secours Charity Health network. The System QA Manager makes sure that quality standards are followed by all departments, provides technical expertise as needed,...

  • System QA Manager

    6 days ago

    Suffern, NY, United States WMC Health Network Full time

    The System QA Manager is responsible for creating and maintaining the laboratory's Quality plan that will be compliant with CLSI, CAP and NYSDOH standards for all hospital locations within the Bon Secours Charity Health network. The System QA Manager makes sure that quality standards are followed by all departments, provides technical expertise as needed,...

  • QA Analyst

    6 days ago

    Durham, NH, United States Lonza Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents. Join Lonza AG as an Associate Director, QA Sterility Assurance - LSA, and become part of an outstanding team dedicated to hardworking and flawless execution in life sciences. This outstanding...

  • QA Automation Engineer

    4 weeks ago

    Detroit, MI, United States Tandym Group Full time

    A top financial company is seeking a QA Automation Engineer. This client is a leader in the web and mobile spaces.Responsibilities:Work alongside QA SMEs and Business/Dev/IT leaders to craft and implement automation strategies for multiple platforms and use cases.Directly execute the overall testing automation strategy, especially as it relates to API...

  • Senior QA Engineer Qa

    1 day ago

    San Francisco, CA, United States YOPESO Vertriebsgesellschaft mbH Full time

    Hands-on development, maintenance, and execution of manual and automated test cases. Participation in the design of the testing software architecture and continuous improvement of code quality. Contributes to code reviews, adhering to coding standards and best practices for maintainable and reliable code. Participation in agile planning and execution process...