Principal Quality Lead (Pharmaceutical)

TL;DR

Principal Quality Lead (Pharmaceutical): Developing and delivering Quality strategies, audits, and compliance conclusions for molecules in development and post-approval products with an accent on GxP frameworks (GCP, GVP, PHC, CS). Focus on leading complex quality strategies, managing regulatory authority inspections, and solving unprecedented compliance problems in a global matrixed organization.

Location: Onsite presence is required at South San Francisco, CA or Oceanside, CA campus

Salary: $158,200 - $293,800

Company

hirify.global, a pioneer in the biotechnology industry, is dedicated to discovering and developing medicines for people with serious and life-threatening diseases.

What you will do

• Design and implement complex Quality strategies based on the Critical to Quality framework (GCP, GVP, PHC, CS).
• Lead the development of audit methodologies and use data analytics to generate quality evidence and insights.
• Conduct and lead 'for cause', critical, and complex audits, ensuring timely reporting and evaluation of actions.
• Manage regulatory authority inspections, including providing staff training and presenting quality conclusions.
• Establish partnerships with stakeholders to define QA approaches and propose strategy modifications.
• Mentor and train International and Senior Quality Leads on GxP regulations and company policies.

Requirements

• Bachelor's degree in a scientific or quality-related field (Advanced degree preferred).
• Minimum 10 years of experience in the pharmaceutical industry or nonclinical/clinical research.
• Minimum 8 years in a Quality Assurance/auditing role related to GCP, PV, or CS.
• Proven track record of leading complex audits in multiple GxP/CSV areas.
• Strong digital and data literacy with the ability to use visualization tools to generate business insights.
• Experience working within a global, multicultural matrixed organization.

Culture & Benefits

• Work for a company recognized on the Fortune 100 Best Companies to Work For list for 24 years.
• Contribute to groundbreaking science in oncology and multiple sclerosis.
• Discretionary annual bonus based on individual and company performance.
• Comprehensive corporate benefits package.