Senior/Principal Manufacturing Compliance Specialist

The Opportunity

This role is a key driver within our Process & Compliance (P&C) team, embedded directly in our state-of-the-art Compounding, Filling, and Inspection (CFI) manufacturing organization in Holly Springs. As part of this high-performing team, you will help establish and sustain the operational baseline for Genentech's largest-ever facility investment, driving innovation and total quality in high-volume drug product manufacturing. You will collaborate closely with cross-functional partners across site operations, quality management, regulatory affairs, and digital systems to ensure seamless startup execution and long-term compliance excellence.

As a Senior/Principal Manufacturing Compliance Specialist for the Apollo 11 project, you will drive manufacturing compliance and operational readiness from initial facility startup through sustained go-live operations in Holly Springs. You will lead the creation and lifecycle management of key cGMP documentation, manage deviations and change controls, and ensure full regulatory compliance across compounding, filling, and inspection operations.

Key Start-Up Responsibilities

• Author, review, and approve critical cGMP documentation, including standard operating procedures (SOPs), work instructions, training materials, and electronic batch records in the MES system.
• Proactively identify and mitigate process risks and inefficiencies during the facility startup phase to ensure flawless operational readiness.
• Own and actively manage major and minor deviations, including third party.
• Own and actively manage change controls.
• Advise on and support development of learning/training materials for the CFI team.
• Support initial regulatory inspections as a technical resource/SME.

Post Go-Live Responsibilities

• Own and actively manage minor, major, and third-party deviations, leveraging root cause analysis (RCA) tools such as "5 Whys" and "Is/Is-Not" to resolve complex operational challenges.
• Facilitate and lead departmental change controls, driving continuous process enhancements, tracking compliance actions, and maintaining operational KPIs.
• Own documentation updates, compliance actions, and other tracking tools related to process enhancements.
• Serve as a Subject Matter Expert (SME), technical resource, and presenter during Health Authority regulatory inspections and site tours.
• Mentor and train P&C team members while leading cross-functional issue resolution across compounding, liquid filling, and automated inspection segments.

Who You Are

• Hold a Bachelor's degree in life sciences, physical sciences, engineering and have 2-4 (Senior) or 5-7 (Principal) years of pharmaceutical industry experience.
• Possess at least 2+ years of hands-on experience owning deviations utilizing standard RCA methodologies (e.g., 5 Whys, Is/Is-Not).
• Have proven technical writing capabilities and experience authoring, reviewing, and approving cGMP documentation within Manufacturing Execution Systems (MES) and QMS/QDocs platforms (e.g., Veeva).
• Possess up-to-date knowledge of cGMPs, Health Authority regulations, Quality Systems, and preferably have exposure to tech transfers, process validation, or regulatory inspections.
• Demonstrate strong problem-solving, project management, and interpersonal skills, with the ability to navigate complex challenges, coach colleagues, and present confidently to small and large groups.
• Comfortable working on-site in a fast-paced environment, including cleanroom/gowned areas (scrubs, bunny suits, safety boots), with up to 10% domestic/international travel.