Senior Manager, QC Chemistry and Device Testing (CVRM)

Location: Holly Springs, North Carolina, United States of America. Relocation assistance is available.

Salary: $120,100–$223,100 per year, plus a potential discretionary annual bonus.

Company

hirify.global, a member of the Roche group, develops medicines for serious and life-threatening diseases through biotechnology and scientific research.

What you will do

• Establish and lead the QC Chemistry and Device Testing organization for CVRM products at a new high-volume drug product manufacturing site.
• Build laboratory capabilities supporting facility, utility, and process qualifications before transitioning to routine commercial operations.
• Define KPIs focused on compliance, Right-First-Time execution, operational performance, and continuous improvement.
• Author, review, and approve test methods, validation protocols, SOPs, and other technical and compliance documents.
• Own QMS records, including investigations, deviations, CAPAs, and change controls, while maintaining audit readiness.
• Partner with global QC teams and lead technology, network-strategy, and operational-improvement projects.

Requirements

• B.S. or M.S. degree in a science-related discipline and at least 8 years of pharmaceutical or biopharmaceutical manufacturing experience.
• At least 3 years of direct QC operations experience at a finished drug product commercial manufacturing site.
• Extensive knowledge of analytical methods, laboratory instrumentation, and analytical method validation, qualification, and transfer.
• In-depth knowledge of cGMP operations, ICH guidelines, and global health authority requirements, including FDA and EMA standards.
• Demonstrated technical leadership, project management, communication, coaching, budget management, and resource-optimization skills.
• Ability to work at the Holly Springs, North Carolina site.

Nice to have

• Experience with a greenfield pharmaceutical or biopharmaceutical project.
• Hands-on knowledge or oversight of medical device functionality testing, such as autoinjectors and pen injectors.
• Formal Operational Excellence certification, such as Lean Six Sigma Green or Black Belt, 5S, or Kaizen.

Culture & Benefits

• Entrepreneurial, fast-paced environment focused on accountability and operational excellence.
• Quality culture built around psychological safety, transparent communication, coaching, and continuous improvement.
• Behavior-Based Safety principles and compliance with site safety and regulatory standards.
• Opportunity to launch a state-of-the-art facility planned to begin operations in 2028.
• Relocation assistance is available for the role.