Senior Manager, Process and Compliance (Assembly and Packaging)

Genentech • Cary, NC

3d • $116,000 - $217,000 • Onsite

About The Position

Genentech is seeking a Senior Manager to lead the Assembly and Packaging Process and Compliance Team for the Apollo 11 project at its Holly Springs, North Carolina site. The facility is being developed as a highly automated, digitally connected manufacturing plant, with operations planned to launch in 2028. The role leads operational readiness, compliance, training, and continuous improvement for Assembly and Packaging.

During startup, the position focuses on SOP and documentation lifecycle strategy, operational risk management, MES batch-record governance, team learning and capability development, deviation and nonconformance investigation governance, change management, and regulatory inspection readiness. After go-live, the role transitions to leading the Process and Compliance Business Unit, with responsibility for team development, deviation and RCA oversight, change controls, continuous improvement, regulatory inspections and responses, departmental metrics, and cross-functional alignment. The position is based at the Holly Springs site, is not eligible for full-time remote work, and qualifies for relocation benefits.

Requirements

• BS or MS degree in Science or Engineering.
• 12+ years of relevant experience in bio/pharmaceutical manufacturing, quality, or engineering.
• Practical knowledge of device assembly and packaging equipment, processes, and materials/components.
• At least 5 years of experience as a deviation owner, using root cause analysis tools such as 5 Whys, Fault Tree Analysis, and Fishbone.
• At least 2 years of experience managing change controls.
• Demonstrated ability to lead cross-functional, multidisciplinary teams and collaborate across Operations, Engineering, QA, Supply Chain, Safety, and other departments.
• Experience working in an FDA-regulated bio/pharmaceutical environment.
• Strong understanding of cGMP regulatory requirements related to pharmaceutical manufacturing processes.
• Strong analytical and problem-solving abilities, including leading complex problem-solving efforts, investigating root causes, and proposing effective solutions to maintain efficient operations and regulatory compliance.

Nice To Haves

• Experience with Veeva QMS and Veeva QDocs.
• Advanced project management skills.
• Experience with high-volume, fully automated device assembly and packaging.
• Greenfield project experience.

Responsibilities

• Lead the Assembly and Packaging Process and Compliance Team and operational readiness efforts for the Holly Springs facility.
• Oversee authorship, review, and lifecycle strategy for manufacturing SOPs, work instructions, and critical documentation.
• Drive proactive operational risk identification and establish mitigation plans.
• Provide strategic oversight for governance, validation, and approval of manufacturing batch records in the MES system.
• Lead the strategy and framework for learning and technical capability development across the Assembly and Packaging team.
• Direct investigation governance and ownership for major and minor deviations and third-party nonconformances.
• Lead change management, including evaluation, approval, and execution of change controls across functional areas.
• Lead initial regulatory inspection readiness and serve as a senior subject matter expert and functional contact for Assembly and Packaging.
• Lead, mentor, and develop high-performing Process and Compliance team members after go-live.
• Oversee major and minor deviations, including investigations involving partners and third-party manufacturers.
• Drive the continuous improvement portfolio, including compliance actions, document updates, and strategic process enhancements.
• Champion complex root cause analysis investigations and cross-functional problem-solving for critical operational issues.
• Oversee the end-to-end change control process to support business evolution and regulatory compliance.
• Lead health authority inspections as a site presenter, process lead, and strategist for regulatory responses and commitments affecting Assembly and Packaging.
• Establish and govern departmental metrics, KPIs, and executive reporting cadence.
• Cultivate an inclusive, high-performing team culture focused on operational excellence, quality, and accountability.
• Direct cross-functional alignment and issue resolution across Assembly and Packaging, site leadership, and cross-site initiatives.

Benefits

• Relocation benefits.
• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits; specific benefits are described at the linked benefits page.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior