Senior Manager, Analytical Sciences and Technology (CVRM)

About the role

The Holly Springs Quality Control team at Roche/Genentech is looking for an experienced leader to establish and head its Analytical Sciences and Technology team. The site is a $2B greenfield manufacturing facility for Cardiovascular, Renal and Metabolism (CVRM) medicines, with a planned launch in 2028. You will first focus on laboratory start-up, establishing QC methods for facility, utility and process qualifications, then move to method lifecycle management and routine QC support, including QC quality records and stability/sampling.

Key responsibilities

• Build a proactive quality culture based on psychological safety, open communication and accountability, and a proactive safety culture through Behavior-Based Safety principles.
• Drive a high-performing lab culture with Lean Leadership, active coaching and continuous improvement.
• Harmonize QC standards with the global network and ensure compliance across site operations.
• Author, review and approve technical, scientific and compliance documents such as test methods, validation and stability protocols and SOPs.
• Establish KPIs focused on compliance, right-first-time execution and continuous improvement.
• Own QMS records, including investigations, deviations, CAPAs and change controls.
• Lead strategic projects supporting the QC network strategy and evaluate new technologies.
• Present QC topics during regulatory inspections and maintain audit readiness.

Required profile

• B.S. or M.S. degree in a science-related discipline, with at least 8 years of experience in pharmaceutical or biopharmaceutical manufacturing, including 3 years in QC operations at a finished drug product commercial site.
• Extensive technical knowledge of analytical methods and laboratory instrumentation, with method validation, qualification and transfer experience.
• Experience owning a stability program at a commercial manufacturing site.
• In-depth knowledge of cGMP, ICH guidelines and FDA, EMA and other global health authority requirements.
• Proven technical leadership, project management and communication skills; extensive deviation investigation experience.
• Preferred: greenfield project experience, medical device functionality testing (autoinjectors, pen injectors), physical chemistry and microbiological method lifecycle management, and contract laboratory method establishment.

What we offer

• Salary range of $120,100 - $223,100 depending on experience, qualifications and location; a discretionary annual bonus may be available.
• Relocation assistance.