Senior Manager, Process and Compliance (Assembly and Packaging)

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 116,000 - 217,000; Full time

Benefits offered by this job

Relocation assistance

Annual bonus

Job summary

Genentech, a member of the Roche group, seeks a Senior Manager to lead the Assembly and Packaging Process and Compliance team at the Holly Springs site. You will manage operational readiness, regulatory readiness, and continuous improvement for SOPs, deviations, and change controls.

The role requires 12+ years in bio/pharma manufacturing, strong RCA skills, and proven cross-functional leadership across Operations, QA, and Safety.

Qualifications

• BS/MS in Science or Engineering with 12+ years in bio/pharma manufacturing, quality, or engineering.
• Experience with device assembly, packaging equipment, and materials/components.
• 5+ years as deviation owner using RCA tools such as 5 Whys, Fault Tree Analysis, and Fishbone.
• 2+ years managing change controls.
• Strong cross-functional collaboration across Operations, QA, Supply Chain, Safety, etc.

Responsibilities

• Oversee SOPs, work instructions, and critical documentation for Assembly and Packaging.
• Drive proactive risk management plans prior to operational impact.
• Govern MES batch records validation and approval framework.
• Lead learning and technical capability development for the A&P team.
• Direct investigation governance for major/minor deviations and third-party nonconformances.
• Lead change controls and regulatory inspections readiness as site SME.
• Mentor and build high-performing A&P team post go-live.

Skills

Deviation ownership

Change controls

Cross-functional leadership

Root cause analysis

Problem solving

Regulatory compliance

Project leadership

Data analysis

Education

BS/MS in Science or Engineering

Tools

Veeva QMS

Veeva QDocs

Job description

Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products. The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028. Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.

The Opportunity

We're seeking a Senior Manager to lead the Assembly and Packaging Process and Compliance Team for the Apollo 11 project based at the Holly Springs site. The successful candidate will lead operational readiness, compliance, training and continuous improvement efforts for the Assembly and Packaging function at the Holly Springs facility. The position transitions from initial site startup strategy—focusing on SOP lifecycle, risk management, MES batch records, and operational and regulatory readiness to post go-live leadership over deviation management, RCA, change controls, continuous improvement, metrics governance, and team development.

Key Start-up Responsibilities

• You will oversee the authoring, review, and lifecycle strategy for manufacturing-centric standard operating procedures (SOPs), work instructions, and critical documentation for the Assembly and Packaging area.
• You will drive proactive risk management initiatives to identify operational risks and inefficiencies in new processes and establish strategic mitigation plans prior to operational impact.
• You will provide strategic oversight for the governance, validation, and approval framework of manufacturing batch records within the MES system.
• You will lead the strategy and framework for learning and technical capability development across the A&P team.
• You will direct the investigation governance and ownership for major/minor deviations and third-party nonconformances.
• You will serve as the primary change management lead, driving evaluation, approval, and execution of change controls across functional areas.
• You will lead initial regulatory inspection readiness, representing the site as a senior SME and functional point of contact for Assembly and Packaging

Post Go-Live Responsibilities

• You will lead, mentor, and build high-performing P&C team members to foster technical excellence and operational capability.
• You will provide oversight and accountability for major and minor deviations, including partner and third-party manufacturing investigations.
• You will drive the continuous improvement portfolio, governing compliance actions, document updates, and strategic process enhancements.
• You will champion complex Root Cause Analysis (RCA) investigations and lead cross-functional problem-solving efforts for critical operational issues.
• You will oversee the end-to-end change control process to support business evolution and regulatory compliance.
• You will lead health authority regulatory inspections as a key site presenter, process lead, and strategist for regulatory responses and commitments impacting the Assembly and Packaging area.
• You will establish and govern departmental metrics, KPIs, and executive reporting cadence to accelerate continuous improvement and business alignment.
• You will cultivate an inclusive, high-performing team culture focused on operational excellence, quality, and high accountability.
• You will direct cross-functional alignment and issue resolution across operational areas (assembly and packaging), site leadership, and cross-site initiatives.

Who You Are

• You have a BS/MS degree in Science or Engineering with 12+ years of deep, relevant bio/pharmaceutical manufacturing, quality, or engineering experience.
• You have practical knowledge of device assembly and packaging equipment, processes, and materials/components.
• You have at least 5+ years experience as a deviation owner, using root cause analysis tools such as “5 Whys”, “Fault Tree Analysis” and “Fishbone”.
• You have 2+ years experience managing change controls.
• You have a demonstrated ability to lead effectively cross-functional and multi-disciplinary teams, and collaborate with colleagues across different functional departments (Operations, Engineering, QA, Supply Chain, Safety, etc.) to enable collective progress across the organization.
• You have experience in working in an FDA regulated bio/pharmaceutical environment, and a strong understandin of cGMP regulatory requirements related to manufacturing processes in the pharma industry.
• You have strong analytical and problem-solving abilities to identify and resolve process-related issues.
• You are able to lead complex problem solving efforts, investigate root causes, and propose effective solutions to ensure efficient operations and compliance with regulatory requirements.

Preferred

• You have experience with Veeva QMS and Veeva QDocs
• You have advanced project management skills
• You have experience with high volume fully automated device assembly and packaging and greenfield project experience.

The expected salary range for this position based on the primary location for this position is $116,000 - $217,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Link to Benefits

This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.