Senior/Principal Manufacturing Compliance Specialist

Genentech • Cary, NC

6d • $79,000 - $169,000 • Onsite

About The Position

The Senior/Principal Manufacturing Compliance Specialist will be part of Genentech’s Process & Compliance team, embedded in the Compounding, Filling, and Inspection (CFI) manufacturing organization at its Holly Springs, North Carolina facility. The role supports startup and operational readiness for a new, highly automated drug product manufacturing facility, then helps sustain compliance and continuous improvement after go-live. The position works with site operations, quality management, regulatory affairs, and digital systems to support high-volume compounding, liquid filling, and automated inspection operations.

During startup, the specialist creates and manages cGMP documentation, supports risk mitigation and readiness activities, manages deviations and change controls, develops training materials, and serves as a technical resource during initial regulatory inspections. After go-live, the role continues to lead deviation investigations, departmental change controls, documentation and compliance tracking, and cross-functional issue resolution. The specialist also serves as an SME during Health Authority inspections and site tours and mentors and trains Process & Compliance colleagues.

The role is based on-site in Holly Springs and involves working in cleanroom or gowned areas, including wearing scrubs, bunny suits, and safety boots. Up to 10% domestic and international travel is expected. The listed salary ranges are $79,000–$146,000 for Senior and $91,000–$169,000 for Principal. A discretionary annual bonus may be available. The position is not eligible for relocation benefits.

Requirements

• Bachelor’s degree in life sciences, physical sciences, or engineering.
• For the Senior level, 2–4 years of pharmaceutical industry experience; for the Principal level, 5–7 years.
• At least 2 years of hands-on experience owning deviations using standard root cause analysis methodologies such as 5 Whys or Is/Is-Not.
• Technical writing capabilities and experience authoring, reviewing, and approving cGMP documentation in Manufacturing Execution Systems (MES) and QMS/QDocs platforms.
• Up-to-date knowledge of cGMPs, Health Authority regulations, and Quality Systems.
• Strong problem-solving, project management, and interpersonal skills.
• Ability to navigate complex challenges, coach colleagues, and present confidently to small and large groups.
• Ability to work on-site in a fast-paced environment, including cleanroom or gowned areas.
• Ability to travel domestically and internationally up to 10%.

Nice To Haves

• Exposure to technology transfers, process validation, or regulatory inspections.
• Experience with Veeva platforms.

Responsibilities

• Author, review, and approve cGMP documentation, including SOPs, work instructions, training materials, and electronic batch records in the MES system.
• Identify and mitigate process risks and inefficiencies during facility startup to support operational readiness.
• Own and actively manage major, minor, and third-party deviations.
• Own and actively manage change controls.
• Advise on and support the development of learning and training materials for the CFI team.
• Support initial regulatory inspections as a technical resource or subject matter expert.
• Use root cause analysis tools, including 5 Whys and Is/Is-Not, to resolve complex operational challenges.
• Facilitate and lead departmental change controls and drive continuous process enhancements.
• Track compliance actions and maintain operational KPIs.
• Manage documentation updates, compliance actions, and tracking tools related to process enhancements.
• Serve as a subject matter expert, technical resource, and presenter during Health Authority inspections and site tours.
• Mentor and train Process & Compliance team members.
• Lead cross-functional issue resolution across compounding, liquid filling, and automated inspection operations.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for benefits described through the Roche/Genentech Benefits link.

What This Job Offers

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