Job Description

About Us :

Modicus Prime’s mission is to improve the quality of pharmaceutical drug manufacturing and save patient lives by leveraging the power of AI and advanced analytics. Our AI platform solves for the cost, legal, and waste liabilities from product quality failures across pharmaceutical R&D and manufacturing. Modicus Prime is a Johnson & Johnson JLABS company and venture-backed by Austin-based Silverton Partners along with strategic partnerships with many large corporations including Takeda Pharmaceuticals, Oak Ridge National Laboratory (DOE), eLabNext (Eppendorf), Dotmatics, and PlugandPlay. Modicus Prime was most recently featured in the Wall Street Journal on July 18th, 2024, following our latest investment announcement.

We are now seeking a Vice President of GxP Quality and Compliance to join our company. If you are eager to impact the AI/ML integration in the pharmaceutical industry and enjoy rapidly scaling products and teams, consider applying to join our company.

Position Overview and Key Responsibilities :

As the VP of GxP Quality and Compliance, you will ensure that all software development, deployment, and operational processes align with Good Manufacturing Practices (GMP) and comply with the latest regulatory standards. Collaborating closely with engineering, quality assurance, regulatory, and leadership teams, you will embed compliance into workflows while driving operational excellence in highly regulated environments.

This role requires a cross-functional understanding of regulatory practices, particularly those governing the deployment of AI/ML-powered software solutions. You will build upon the company’s GxP compliance strategy, ensuring alignment with regulatory requirements, including FDA and EMA guidelines. Additionally, you will train and mentor both our team and our customers on GxP requirements related to AI/ML utilization, fostering a culture of compliance and quality excellence. Furthermore, you will oversee the creation, implementation, and monitoring of policies and procedures to ensure GxP compliance across all software development and deployment activities.

A key aspect of your role will involve supporting our customers in understanding and implementing a wide range of AI/ML software solutions within a GxP environment. You will provide expertise to help them navigate regulatory challenges and effectively deploy compliant AI/ML models using our software. By staying informed of regulatory changes and emerging trends in GxP compliance, you will proactively adapt company strategies and practices to maintain industry leadership.

You will also represent the company as a subject matter expert in GxP compliance during client engagements, industry forums, and regulatory interactions, ensuring our solutions meet the highest standards and foster customer trust.

This role is U.S.-based, and visa sponsorship cannot be accommodated at this time.

Basic Qualifications :

• 10+ years of experience in regulatory compliance roles within the pharmaceutical or biotech industries.
• Proven experience in leading cross-functional teams of engineers, quality assurance professionals, and regulatory experts to develop and implement strategies for AI/ML system validation in compliance with GxP standards.
• Extensive knowledge of GxP guidelines, including 21 CFR Part 11, GAMP 5, and EMA guidelines.
• Proven expertise in computer system validation (CSV) and experience managing validation processes for software in regulated environments.
• Strong understanding of GxP-compliant software development lifecycles, including change control and risk management.
• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Regulatory Affairs, or a related field.
• Proven experience with AI/ML systems and their validation in GxP environments.
• Experience with cloud-based GxP-compliant systems, such as AWS or Google Cloud.
• Certifications such as Certified Quality Auditor (CQA) or Certified Software Quality Engineer (CSQE).

Additional Information:

1. Location: Austin preferred

2. Job Type: Full-time

3. Pay (with equity): $200k - $220k depending on skills and/or qualifications

What We Offer :

• Enjoy the benefits of a flexible work schedule within a remote working environment, while also having the opportunity to connect with your colleagues through regular in-person meetings in Austin, including team luncheons.
• The chance to lead groundbreaking AI initiatives that are transforming the pharmaceutical industry.
• A supportive and collaborative team culture, with ample opportunities for professional growth and development, including conference speaking opportunities.

Equal Opportunity Employer Statement:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.

To Apply :

Please submit your CV and any relevant materials to info@modicusprime.com . We look forward to hearing from you and exploring how your ambitions and expertise can help shape the future of Modicus Prime and the pharmaceutical industry at large.

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