Validation System Business Process Owner (BPO)

TL;DR

Validation System Business Process Owner (BPO) (Biotech/Pharma): Ensuring the integrity and compliance of digital validation systems and processes with an accent on cGMP regulations and Roche standards. Focus on optimizing Qualification/Validation business processes, leading enterprise-wide change management, and architecting robust mitigation plans for global manufacturing sites.

Location: Must be based in Holly Springs, NC or Philadelphia, PA

Salary: $114,400–$212,400

Company

hirify.global, a member of the Roche group, is a pioneer in the biotechnology industry dedicated to discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Drive and implement sustainable digital validation system strategies in collaboration with global teams.
• Optimize and build Qualification/Validation business processes and maintain documentation standards.
• Collaborate with cross-functional experts in Quality, Manufacturing, Engineering, and IT to ensure harmonized solutions.
• Act as a primary thought partner to senior management, translating technical challenges into strategic insights.
• Lead enterprise-wide change management and training programs for advanced validation systems.
• Manage the end-to-end lifecycle of master data and templates within the Validation System.

Requirements

• Bachelor's or Master's degree in Engineering, Life Sciences, or related technical field.
• 10+ years of experience in the pharmaceutical or biotechnology industry.
• Deep knowledge of FDA (CFRs), EMA, and ICH regulations, specifically 21 CFR Part 11.
• Proven track record in matrix leadership and cross-functional team management.
• Ability to travel domestically and internationally up to 20% of the time.
• Must be authorized to work in the United States.

Nice to have

• Experience with Validation Lifecycle Management Systems (VLMS).
• Demonstrated ability to lead enterprise-level projects from requirements analysis to implementation.

Culture & Benefits

• Competitive salary with discretionary annual bonus based on performance.
• Comprehensive benefits package including health, retirement, and wellness programs.
• Opportunity to work in a global, science-driven environment with a focus on patient impact.
• Commitment to diversity, inclusion, and equal opportunity employment.