Senior Manager, GCP Auditing
Novartis - Emeryville, CA

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About Novartis Vaccines and Diagnostics:
The Novartis Vaccines and Diagnostics Division provides more than 20 products to fight vaccine-preventable viral and bacterial diseases. It also creates sophisticated instruments, assays and software to test blood donations for infections.

Our Mission: We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life.
We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest ideas and work in our company.

Our Culture: At Novartis, our performance-oriented culture and responsible approach are the foundations of our success. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.

Novartis ranked in the top three among pharmaceutical companies in Fortune magazine’s “World’s Most Admired Companies” for the past six years.
Honored by National Organization for Rare Disorders Corporate Award for our research on rare diseases.
DiversityInc ranks Novartis #7 in its Top 10 Companies for Global Diversity in 2010, second year in a row we were in the top 10.
We are currently seeking an experienced Senior Manager, GCP Auditing to join our team in Emeryville, California. Working as a member of a dynamic, global clinical quality group this position will have an emphasis on IV diagnostics.

Responsibilities:
  • Accountable for proper execution and completion of audits based on the CQA audit program and CQA Standard Operating Procedures; Takes a lead role in tracking progress of projects/studies to be audited for planning and scheduling purposes as assigned by the global audit program
  • Accountable for the management and selection of external consultants for audit purposes
  • Independently Lead / co-lead study audits at investigator sites globally
  • Takes a lead role in the review of document audits such as, Clinical Study Reports and Safety Reports and other audits and assessments as required.
  • Takes a lead in proper assessment and conduct of internal system audits and assists in vendor and CRO audits as specified in the audit program
  • Prepare written audit reports using the audit report database and report templates
  • Accountable for proper evaluation; adequacy and completeness of corrective and preventive action plans (CAPA).
  • Participates and/or leads process improvement initiatives as it related to CQA auditing and related processes and ensures measuring the effectiveness of such initiatives
  • Maintain required knowledge of applicable regulations, industry and company GCP standards and procedures
  • May serve as an advisor on GCP related topics for clinical operations staff and contribute to CQA GCP forum presentation, development, and may execute other trainings as required.
  • Support regulatory inspections as necessary
  • Trains new or junior staff in Clinical QA on auditing practices and techniques
  • May act as owner of CQA SOPs relating to audit preparation, executing and reporting
Compensation and Benefits:
The success of Novartis depends on the performance and dedication of our Group company associates. We strive to be an employer of choice that attracts, retains and motivates talented and performance-driven people to our affiliates around the world.
Novartis benefits programs are an integral part of the total compensation policy and strategy and are designed to meet the challenges of growing, global competition for talent.
These programs support the overall business objectives and strategy of Novartis. Benefits are aligned with local legislation and practices in each country and are established to provide a framework of security for associates. Minimum requirements Requirements:
  • B.S. degree in biology or chemistry
  • Minimum of 5 years of GCP auditing experience. Additional clinical research experience in setting up and overseeing clinical trials is desirable.
  • Strong understanding of GCP regulations and experience with site inspections and management.
  • Superb interpersonal and communication skills
  • Domestic and International Travel required. Niche

Novartis - 3 years ago - save job - block
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About this company
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Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...