Senior Manager, QC Chemistry and Device Testing (CVRM)

About the role

The Holly Springs Quality Control team at Roche/Genentech is looking for an experienced leader to establish and head its QC Chemistry and Device Testing team. The role builds a team that delivers safe, compliant and efficient testing for CVRM (Cardiovascular, Renal, and Metabolism) products at the new Holly Springs site, initially through laboratory start-up work before moving to routine commercial operations after site licensure.

Key responsibilities

• Lead the QC Chemistry and Device Testing team, building a proactive quality and safety culture based on psychological safety, Behaviour-Based Safety and Lean Leadership.
• Establish KPIs focused on compliance, right-first-time execution and continuous improvement.
• Author, review and approve technical, scientific and compliance documents such as test methods, validation protocols and SOPs.
• Own QMS records including investigations, deviations, CAPAs and change controls.
• Take part in evaluating and implementing new technologies and lead strategic QC projects.
• Present QC topics during regulatory inspections and maintain audit readiness.
• Partner with the global network to harmonize QC standards and ensure compliance across sites.

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 at a finished drug product commercial site.
• Proven technical leadership, project management and budget management (OpEx/CapEx).
• Excellent communication and coaching skills, with experience managing budgets and optimizing resources.
• Preferred: greenfield project experience, hands-on device functionality testing (autoinjectors, pen injectors), and Operational Excellence certification (Lean Six Sigma, 5S, Kaizen).

Required skills

• Analytical methods, instrumentation and method validation, qualification and transfer.
• cGMP operations, ICH guidelines and FDA, EMA and other regulatory requirements.

What we offer

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