Senior Manager, Process and Compliance (Assembly and Packaging)

Roche • Holly Springs, 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 drug product manufacturing plant, with a planned operational launch in 2028. The role leads operational readiness, compliance, training, and continuous improvement for Assembly and Packaging.

During startup, the position focuses on the strategy and oversight of SOPs and critical documentation, operational risk management, MES batch record governance, learning and technical capability development, deviation investigations, change controls, and regulatory inspection readiness. Following go-live, the role leads the Process and Compliance Business Unit, including team development, deviation and investigation oversight, continuous improvement, complex root cause analysis, change control, health authority inspections and responses, departmental metrics, and cross-functional alignment.

The position is based in Holly Springs and is not eligible for full-time remote work arrangements. Relocation benefits are available. The expected salary range is $116,000–$217,000, with a discretionary annual bonus potentially available based on individual and company performance. The position qualifies for company benefits; specific benefits are not enumerated in the posting.

Requirements

• BS or MS degree in Science or Engineering.
• 12+ years of relevant bio/pharmaceutical manufacturing, quality, or engineering experience.
• Practical knowledge of device assembly and packaging equipment, processes, and materials or 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 and multidisciplinary teams and collaborate across departments such as Operations, Engineering, QA, Supply Chain, and Safety.
• 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 solutions that support 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 oversee operational readiness, compliance, training, and continuous improvement.
• Oversee the authoring, review, and lifecycle strategy for manufacturing SOPs, work instructions, and critical documentation.
• Drive proactive operational risk identification and establish mitigation plans.
• Provide strategic oversight of governance, validation, and approval frameworks for 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 as a senior subject-matter expert and functional point of contact for Assembly and Packaging.
• After go-live, lead, mentor, and develop Process and Compliance team members.
• Oversee major and minor deviations, including partner and third-party manufacturing investigations.
• Govern the continuous improvement portfolio, including compliance actions, document updates, and strategic process enhancements.
• Lead complex root cause analysis investigations and cross-functional problem-solving for critical operational issues.
• Oversee the end-to-end change control process.
• 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 are available.
• A discretionary annual bonus may be available based on individual and company performance.
• The position qualifies for company benefits; the posting refers to a benefits link but does not specify the individual benefits.

What This Job Offers

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