Senior/Principal Manufacturing Compliance Specialist

Roche • Holly Springs, NC

6d • $79,000 - $169,000 • Onsite

About The Position

The Senior/Principal Manufacturing Compliance Specialist is a key contributor to Genentech’s Process & Compliance team, embedded in the Compounding, Filling, and Inspection (CFI) manufacturing organization at its Holly Springs, North Carolina facility. The facility is Genentech’s largest-ever investment and is being developed as a highly automated, digitally connected drug product manufacturing plant, with operations planned to launch in 2028.

The role drives manufacturing compliance and operational readiness from facility startup through sustained go-live operations. It leads the creation and lifecycle management of cGMP documentation, manages deviations and change controls, and supports regulatory compliance across compounding, filling, and inspection. The specialist collaborates with site operations, quality management, regulatory affairs, and digital systems, and contributes to startup execution and long-term compliance excellence.

During startup, the specialist authors, reviews, and approves cGMP documentation; identifies and mitigates process risks; manages deviations and change controls; supports training material development; and serves as a technical resource during initial regulatory inspections. After go-live, the specialist continues deviation and change-control ownership, drives process enhancements and compliance tracking, serves as an SME during inspections and site tours, and mentors team members. The role is on-site, includes work in cleanroom/gowned areas, and requires up to 10% domestic or international travel.

Requirements

• Bachelor’s degree in life sciences, physical sciences, or engineering.
• At least 2 years of hands-on experience owning deviations using standard root cause analysis methodologies such as 5 Whys or Is/Is-Not.
• Proven technical writing capabilities and experience authoring, reviewing, and approving cGMP documentation within 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/gowned areas.
• Willingness to travel up to 10% domestically and internationally.

Nice To Haves

• Exposure to technology transfers, process validation, or regulatory inspections.
• Experience with 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 and subject matter expert.
• Use root cause analysis methods, including 5 Whys and Is/Is-Not, to investigate and resolve complex operational challenges.
• Facilitate and lead departmental change controls and drive continuous process enhancements.
• Track compliance actions and operational KPIs.
• Maintain documentation updates, compliance actions, and tracking tools related to process enhancements.
• Serve as an SME, 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 at the linked Roche/Genentech Benefits page.

What This Job Offers

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