Tech Ops Los Angeles, California, United States Full time 0022
At A2, our mission is to extend the reach of cell therapy to tackle the next frontier in cancer treatment: solid tumors.
Our team is dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illness.
Central to achieving this mission is our focus on recruiting the best talent and building an environment that enables our team to do the best work of their careers and make an impact on patients and society at large.
We are seeking a highly motivated Senior Manager, Quality to join our team reporting to the Head of Quality.
In this role, you will implement and execute the phase appropriate Quality Management System (QMS) enabling clinical investigational cell therapy manufacturing at our Agoura Hills California site.
You will be responsible for building and managing a Quality Operations/Systems team working in a matrix environment within A2’s Technical Operations function.
This position requires demonstrated Quality leadership and business acumen to drive operational objectives that ultimately contribute to our mission of changing cancer patients’ lives.
If you are looking to join a fun, fast paced & growing team in a cell therapy/tech ops environment…apply today!
Responsibilities:
Working within A2 Quality policies and guidance, establish and implement the Quality Operations unit in the A2 clinical manufacturing site.
Implement supporting, phase appropriate Quality Systems to enable FIH (First in Human) clinical manufacturing.
Support clinical product(s) tech transfer from Process Development to Manufacturing functions.
Support quality requirements for analytical tech transfer to clinical Quality Control unit, as applicable.
Recruit, develop and manage performance of QA/QS staff.
Prepare budget and resource plan, as directed.
Train and manage performance of direct reports in respect to environmental health and safety guidelines.
Train Tech Ops staff on Quality standards, as applicable.
Document and perform quality investigations, as needed, to ensure continuous improvement in product/process quality.
Perform GMP auditing of internal functions, and external services/suppliers, as directed.
Provide quality data and KPI summaries to support internal quality review meetings.
Write and review/approve technical documentation including SOPs, quality assurance electronic records, technical reports and summary reports.
Support the preparation of data packages for regulatory agencies and/or presentation, as required.
Work with A2 CMOs to establish phase appropriate quality/compliance requirements in the receipt and utilization of critical manufacturing reagents.
Work cross-functionally with Manufacturing, Process Development, Facilities/Engineering, and Supply Chain to execute on corporate goals.
Requirements
Basic Qualifications:
Bachelor’s degree in biology, biochemistry, bioengineering or related discipline and 10+ years of biotechnology or biopharmaceutical experience in clinical/commercial operations.
Of which 2+ years must be in cell/gene therapy products.
Minimum of 5 years’ management experience directly managing people and / or leading teams, projects, or programs.
Must have operational knowledge of applicable GMPs, ICH, and ISO regulatory requirements for drug/biologics.
Preferred Qualifications:
Ability to design and implement phase appropriate quality operations and systems meeting FDA requirements, in cell/gene therapy manufacturing.
Ability to use sophisticated analytical thinking to resolve operational problems and challenges, while paying attention to timelines and priorities.
Proven track record of independent decision making in functional/high matrixed issue resolution.
Proven ability to develop staff and build high performing teams.
Highly motivated, proactive and enthusiastic team player who builds strong relationships with colleagues and partners to deliver on corporate goals.
Ability to work independently, collaborate cross-functionally and utilize resources efficiently.
Excellent organizational, interpersonal, verbal and written communication skills.
At A2 we believe in investing in our team.
Our compensation & benefits programs are just one of the many ways we strive to help our employees take care of themselves and their families.
We offer a variety of programs, from comprehensive medical insurance to generous time off policies designed to help meet the needs of our diverse team.
Compensation and benefits include:
Competitive base salary and annual incentive opportunities Equity participation Comprehensive health and welfare benefits (including medical, dental, vision, life, disability, and accident insurance) Wellness and recognition programs Paid time off and holidays Environment where professional development is actively encouraged and supported.
Equal Opportunity Statement:
A2 is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.