External Quality Senior Associate

United States, Hayward (California)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The QA External Quality Senior Associate will serve as the External QA subject matter expert for process validation activities and tech transfer of manufacturing processes.  For these quality-related items, the incumbent manages the process for notifying the customer and assuring the customer’s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale, that root cause analysis and corrective and preventive action is appropriate and, where applicable, that customer approval is received.  

The QA External Quality Senior Associate leads Joint Quality Team meetings –establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QA representative and tracks and publishes monthly and quarterly quality KPIs.

Key Accountabilities:

  • Partner with internal customer as part of moderately complex change control review serving as the Quality Subject Matter Expert and Final QA approver.
  • Partners with internal customers such as MSAT, Manufacturing, and Engineering etc. as part of the Process Validation team serving as the Quality SME and/or final QA approver
  • Deviation / Investigation / CAPA support – Full Root cause analysis, review and approval of TrackWise related records.
  • Interact with internal and external customer as part of Joint and Internal project Teams serving as the Quality Subject Matter Expert for any customer related quality issues. Supports multiple customers.
  • Reviewing and approving various product specific documents, as needed. To include Product Quality Reviews, Tech Transfers and Process Validaiton documents.
  • Lead projects define project plan, scope, and deliverables as assigned.  Manage and track Key Performance Indicator Quality metrics and attend other meetings- represent department at site meetings (lot release, CRB, Q Council)
  • Support Customer and/or Regulatory audits and inspections
  • Act as the Quality delegate when requested including meeting coverage and delegation of tasks.

 Key Requirements:

  • Bachelors required
  • Managed and developed strategies for Process Validation activities for commercial Biotech/Pharma processes
  • Project Management including public speaking/presentation skills, building and maintaining strong Customer relationships, meeting facilitation  
  • Self-starter, excellent written and verbal communication at all levels, able to manage challenging workloads and changing priorities, excellent attention to detail, works effectively individually and with teams, positive attitude, customer focused, works well under pressure, confident making quality decisions, able to motivate others. Practices safety awareness at all times and considers impact of actions prior to executing activities.
  • Experience with Commercial Cell Culture and Downstream Recovery activities.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement themselves.  At Lonza, we respect and protect our people and our environment.  Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R27662