Senior Manager, Process and Compliance (Assembly and Packaging)

Genentech • Holly Springs, NC

1d • Onsite

About The Position

Genentech is seeking a Senior Manager to lead the Assembly and Packaging Process and Compliance (P&C) 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 target of launching operations in 2028. The role leads operational readiness, compliance, training, and continuous improvement for Assembly and Packaging.

During startup, the Senior Manager will establish strategies and governance for SOPs and critical documentation, operational risk management, MES batch records, team learning and technical capability, investigations, change controls, and regulatory inspection readiness. Following go-live, the role will lead the P&C Business Unit, developing the team and overseeing investigations, root-cause analysis, change controls, continuous improvement, regulatory inspections, departmental metrics, and cross-functional alignment.

The position is based at the Holly Springs site and is not eligible for full-time remote work arrangements. Relocation benefits are available. The expected salary range is $116,000–$217,000. A discretionary annual bonus may be available based on individual and Company performance. The position also qualifies for benefits detailed at the link provided 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/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 with 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 to identify and resolve process-related issues.
• Ability to lead complex problem-solving efforts, investigate root causes, and propose effective 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 operational readiness, compliance, training, and continuous improvement for the Assembly and Packaging function.
• Oversee authoring, review, and lifecycle strategy for manufacturing SOPs, work instructions, and critical documentation.
• Drive proactive identification of operational risks and inefficiencies 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.
• Serve as the primary change management lead, driving evaluation, approval, and execution of change controls across functional areas.
• Lead initial regulatory inspection readiness and represent the site as a senior subject-matter expert and functional contact for Assembly and Packaging.
• After go-live, lead, mentor, and develop P&C team members to foster technical excellence and operational capability.
• Oversee and provide accountability for major and minor deviations, including partner and third-party manufacturing investigations.
• Drive 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 to support business evolution and regulatory compliance.
• Lead health authority regulatory 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.
• Eligibility for company benefits detailed at the link provided in the posting.
• A discretionary annual bonus may be available based on individual and Company performance.

What This Job Offers

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