Senior/Principal Manufacturing Compliance Specialist

Genentech • Holly Springs, NC

5d • Onsite

About The Position

The Senior/Principal Manufacturing Compliance Specialist will be a key member of the Process & Compliance team embedded in Genentech’s Compounding, Filling, and Inspection (CFI) manufacturing organization in Holly Springs, North Carolina. The role supports startup and sustained operations at the site, helping establish operational readiness and compliance for high-volume drug product manufacturing. It works closely with site operations, quality management, regulatory affairs, and digital systems.

For the Apollo 11 project, the specialist will drive manufacturing compliance from initial facility startup through go-live and ongoing operations. The role leads creation and lifecycle management of cGMP documentation, manages deviations and change controls, and supports regulatory compliance across compounding, filling, and inspection. During startup, the specialist will help ensure operational readiness and support initial regulatory inspections. After go-live, the role will lead compliance activities, support continuous improvement, serve as a regulatory inspection subject matter expert, and mentor team members.

The position is based on-site in Holly Springs and includes work in cleanroom or gowned areas. Up to 10% domestic or international travel may be required. The stated 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 capability and experience authoring, reviewing, and approving cGMP documentation in Manufacturing Execution Systems 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.
• Willingness to travel domestically or internationally up to 10%.

Nice To Haves

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

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 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 investigate and resolve operational challenges.
• Lead departmental change controls and continuous process enhancements; track compliance actions and 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.

Benefits

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

What This Job Offers

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