Senior/Principal Manufacturing Compliance Specialist

Genentech; Holly Springs (NC); Sur place; USD 79 000 - 169 000; Plein temps

Résumé du poste

Genentech in Holly Springs, NC, seeks a Senior/Principal Manufacturing Compliance Specialist to drive cGMP documentation and regulatory readiness for the Apollo 11 project. You will manage deviations, changes, and inspections while partnering across site operations, quality, regulatory affairs, and digital systems.

The role requires hands-on experience with MES/QMS (e.g., Veeva), strong RCA skills, and a bias for continuous improvement in a fast-paced, plant-of-the-future environment with up to

Qualifications

• Bachelor’s degree in life sciences, physical sciences, or engineering required.
• 2+ years hands-on experience owning deviations using RCA methods (5 Whys, Is/Is-Not).
• Experience authoring, reviewing, and approving cGMP docs in MES/QMS like Veeva.

Responsabilités

• Author, review, and approve cGMP documentation (SOPs, work instructions, training materials, eBRs) in MES.
• Identify and mitigate startup risks to ensure operational readiness.
• Manage deviations and change controls; support regulatory inspections as SME.
• Mentor P&C team and lead cross-functional issue resolution.
• Post go-live: drive continuous improvements and maintain KPIs.

Connaissances

Problem solving

Project management

Interpersonal skills

Technical writing

Formation

Bachelor’s degree in life sciences/physical sciences/engineering

Outils

Veeva

MES

QMS

Description du poste

The Position

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:

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:

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

Post Go-Live Responsibilities:

• You will 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.
• You will facilitate and lead departmental change controls, driving continuous process enhancements, tracking compliance actions, and maintaining operational KPIs.
• You will own documentation updates, compliance actions, and other tracking tools related to process enhancements.
• You will serve as a Subject Matter Expert (SME), technical resource, and presenter during Health Authority regulatory inspections and site tours.
• You will mentor and train P&C team members while leading cross-functional issue resolution across compounding, liquid filling, and automated inspection segments.

Who You Are:

• You 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.
• You possess at least 2+ years of hands-on experience owning deviations utilizing standard RCA methodologies (e.g., 5 Whys, Is/Is-Not).
• You 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).
• You possess up-to-date knowledge of cGMPs, Health Authority regulations, Quality Systems, and preferably have exposure to tech transfers, process validation, or regulatory inspections.
• You 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.
• You are 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.

The expected salary range for this position based on the primary location for this position of Holly Springs, NC is $79,000 - $146,000 (Senior) or $91,000 - $169,000 (Principal) . 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.

This position is not eligible for relocation benefits

Link to Roche/Genentech Benefits

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.