Job Description Summary
Project lead for Analytical Method transfers and post-importation testing exemption application management
Job Description
Major Accountabilities:
• Establish and maintain a prioritised tracker for all post importation exemption applications. Coordinate supporting documents from manufacturing sites and relevant functions. Compile and quality-check submission packages. Coordinate submission applications, proof of payment and respond to Health Authority queries. Escalate overdue inputs through established governance channels.
• Analytical Method transfer: 1) Lead end-to-end method transfer schedules between sites and the local laboratory, 2) Draft, review, and approve method transfer plans, protocols, comparative testing strategies, acceptance criteria, and final reports. 3) Act as the Subject Matter Expert (SME) to resolve out-of-specification (OOS) results, deviations, and analytical challenges, 4) Ensure equipment and reference standards are available
• Complete an orderly handover at the end of the project.
Key Performance Indicators:
• Adherence to cGMP and SOPs
• Project targets are met
• Quality related processes carried out in a timely way
• GxP risks proactively identified and effectively mitigated
• Timely close out of deviations, out of specifications and corrective and preventative actions
• Compliance with all aspects of the Code of Conduct/ Novartis Policies and Procedures
Minimum Requirements:
Work Experience:
• Managed health authority submissions and applied guidelines to ensure compliance.
• Engaged with SAHPRA on regulatory, quality, and compliance-related matters.
• Post-importation testing exemption and analytical method transfer.
• Collaborated with Quality Control (QC) laboratories to support testing, investigations, and compliance requirements.
Skills:
• Knowledge and understanding of GMP, quality systems and quality and regulatory practices
• Understanding and interpretation of regulations & guidelines
• Document management
• Analytical thinking and problem solving
• Project management
• Planning & organizing
• Good time management
• High compliance
• Communication and interpersonal skills.
• Self Awareness
Languages :
• English.
Skills Desired
Collaboration, Communication, Compliance Reviews, Data Integrity, Decision Making, GMP Compliance, Managing Ambiguity, Problem Solving, Process Improvements, Project Management, Quality Assurance (QA), Quality Compliance, Quality Management, Quality Management Systems (QMS), Quality Manuals, Regulatory Compliance, Regulatory Requirements, Risk Management, SOP DocumentationSkills Required
- Experience managing health authority submissions and applying guidelines to ensure compliance
- Experience engaging with SAHPRA on regulatory, quality, and compliance matters
- Experience with post-importation testing exemptions and analytical method transfers
- Experience collaborating with Quality Control laboratories on testing, investigations, and compliance requirements
- Knowledge of GMP, quality systems, and quality and regulatory practices
- Understanding and interpretation of regulations and guidelines
- Document management skills
- Analytical thinking and problem-solving skills
- Project management skills
- Planning and organizing skills
- Good time management
- High compliance orientation
- Communication and interpersonal skills
- Self-awareness
- English language proficiency
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
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.
