QA Manager Operations

Posted 2 Days Ago
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Sandoz, CA
Senior level
Biotech • Pharmaceutical
The Role
The QA Manager Operations is responsible for ensuring compliance with cGMP regulations and managing quality aspects in production and testing. Key responsibilities include oversight of production activities, batch release execution, exception investigations, technical complaint reporting, and supporting continuous improvement projects.
Summary Generated by Built In

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!
Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures  


 

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

  • Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
  • Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review
  • Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration
  • Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
  • On-time and GMP-compliant release of dosage forms -No Complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
  • Successfully Support continuous improvement Projects -Executes batch release in compliance with registration  

What you’ll bring to the role:Essential Requirements:

  • Minimum 10-15 years of experience in handling ointments, creams and lotions
  • Critical Negotiations.
  • Functional Breadth.
  • Project Management.
  • People Leadership.
  • Collaborating across boundaries.
  • Operations Management and Execution.

Skills:

  • Continuous Learning.
  • Dealing With Ambiguity.
  • Employee Performance Evaluations.
  • Gmp Procedures.
  • People Management.
  • Qa (Quality Assurance).
  • Quality Control (Qc) Testing.
  • Quality Standards.
  • Self Awareness.
  • Technological Expertise.
  • Technological Intelligence.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

The future is ours to shape!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.


 

Skills Desired

Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Top Skills

Gmp
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The Company
HQ: Basel
110,000 Employees
Hybrid Workplace
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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