Wake County, North Carolina, United States · On-site
$115k–$213k/yr
The Position Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence conve…
Skills: Quality Compliance, GxP Regulations, Risk-based Quality Management, Data Integrity, Strategic Project Leadership
Orange Township, Ohio, United States · Remote OK
$171k–$317k/yr
The Position Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity w…
Skills: Strategic leadership, Patient navigation, Reimbursement, Healthcare management, Team management
Berwyn, Illinois, United States · On-site
$163k–$302k/yr
The Position Senior Thought Leader Liaison (TLL) - Neuroimmunology We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of…
Skills: Neuroimmunology, Thought leader engagement, Strategic planning, Clinical data education, Market shaping
Daly City, California, United States · Hybrid
$157k–$291k/yr
The Position Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity w…
Skills: Vendor governance, SLA management, Operational excellence, Strategic planning, Capacity planning
Daly City, California, United States · On-site
$159k–$295k/yr
The Position The Opportunity In partnership with user and leadership teams across PAA (and select teams across CMG), this role will develop strategy, vision and be accountable to deliver and maintain products and tools t…
Skills: Product management, Market access, Contracting strategy, Agile methodology, Stakeholder management
Daly City, California, United States · On-site
$168k–$312k/yr
The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we al…
Skills: Antibody engineering, Biophysics, Computational biology, Machine learning, Python
Daly City, California, United States · On-site
$201k–$374k/yr
The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we al…
Skills: Machine learning, Artificial intelligence, Antibody engineering, Biophysical modeling, Drug discovery
Daly City, California, United States · Hybrid
$138k–$257k/yr
The PositionWhy Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity wh…
Skills: Compliance auditing, Risk mitigation, Healthcare compliance, Anti-kickback statute, Fraud and abuse laws
New York, New York, United States · On-site
$96k–$179k/yr
The Position Surgical Device Specialist (SDS), Ophthalmology – NY Metro An ever-transforming healthcare landscape requires a high level of agility and flexibility to navigate. At Genentech, we pride ourselves in our abil…
Skills: Surgical Device Training, Customer Relationship Management, Consultative Selling, Lead Generation, Technical Education
Hillsboro, Oregon, United States · On-site
$79k–$146k/yr
The Position Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Manufacturing…
Skills: MES, Computer System Validation, Change Management, SAP, PLC
Los Angeles County, California, United States · On-site
$138k–$255k/yr
The Position The Opportunity: As a Neurological Rare Disease Account Manager you will manage and develop long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As…
Skills: Account management, Sales, Healthcare provider relations, Reimbursement support, Clinical education
Arabi, Louisiana, United States · Hybrid
$103k–$192k/yr
The Position As a Clinical Research Engagement Lead (CREL) at Roche, you will act as the ultimate strategic partner and primary face of Roche Clinical Operations within your market. This is not a traditional coordination…
Skills: Clinical operations, Site engagement, Strategic planning, Study start-up, Relationship management
Hillsboro, Oregon, United States · On-site
$43k–$97k/yr
The Position Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations or…
Skills: Manufacturing, Equipment maintenance, Troubleshooting, Sterile filling, Packaging
Florence-Graham, California, United States · Remote OK
$160k–$297k/yr
The Position The Opportunity The State Government Affairs (SGA) Director is responsible for working collaboratively with internal and external stakeholders across the assigned states and Genentech’s Customer Engagement (…
Skills: Government affairs, Lobbying, Legislative advocacy, Strategic planning, Policy development
Oklahoma City, Oklahoma, United States · On-site
$138k–$255k/yr
The Position Therapeutic Area Manager (TAM), Immunology – Texoma Ecosystem From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single…
Skills: Account management, Immunology, Clinical sales, Strategic planning, Reimbursement
Hillsboro, Oregon, United States · On-site
$97k–$181k/yr
The Position Genentech's Hillsboro Technical Operations (HTO), located in Hillsboro Oregon, is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/…
Skills: Project management, Portfolio management, GMP, Fill/finish operations, Cross-functional leadership
Daly City, California, United States · On-site
$90k–$167k/yr
The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we al…
Skills: Administrative support, Calendar management, Travel logistics, Expense reporting, Event planning
Daly City, California, United States · On-site
$86k–$159k/yr
The PositionScientist 2 Neuroscience, gRED The Department of Neuroscience is seeking a highly motivated and talented researcher to join us as Scientist and contribute to our cutting-edge basic biology and drug discovery …
Skills: Neuroscience, Molecular biology, Cell biology, Primary rodent cultures, Live cell imaging
Daly City, California, United States · Hybrid
The Position Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while bo…
Skills: Product Management, Data Science, Artificial Intelligence, Machine Learning, Generative AI
Daly City, California, United States · Hybrid
$162k–$301k/yr
The Position Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity w…
Skills: Marketing strategy, Brand positioning, Market analysis, Competitive assessment, Customer journey mapping
Wake County, North Carolina, United States • On-site
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The Principal Quality Compliance Specialist will lead strategic quality initiatives and serve as the site expert on digital compliance and risk-based quality management. They will partner cross-functionally to embed a robust Quality Management System and drive continuous improvement across the manufacturing facility.
Candidates must hold a bachelor's degree in a scientific or technical discipline and possess 8–10 years of experience in a GxP environment. Deep expertise in global regulations, data integrity, and leading strategic quality projects in sterile manufacturing is required.
Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.
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 meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.
Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and 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.
We seek a highly impactful Principal Quality Compliance Specialist who possesses extensive experience in quality, compliance, and project execution, combined with a strong risk-based operational focus. In this critical role, you will lead a portfolio of diverse, strategic quality initiatives and be the site expert on digital compliance. This facility will ensure the consistent manufacturing of high-quality products that meet global regulatory requirements and Roche's rigorous internal standards.
As a Principal Quality Compliance Specialist, you will serve as the foundational compliance anchor and strategic project leader within our Quality Compliance team. You will play a vital role in embedding a robust, risk-based Quality Management System (QMS) across the site while championing continuous improvement initiatives that span local operations and global networks.
This position is a unique opportunity to embed a robust, risk-oriented Quality Culture into the site's operational design, support a continuous improvement culture, and drive operational excellence, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.
What You’ll Do
Lead Strategic Quality Projects:
Act as the primary site liaison for global compliance trends, knowledge sharing, and improvement initiatives.
Execute strategic Global Quality projects by translating network mandates into actionable project plans.
Develop and oversee local implementation strategies, ensuring alignment with project timelines.
Drive strategic site quality improvement initiatives to enhance operational performance.
Coordinate and lead targeted deep-dive assessments and complex risk assessments.
Apply QRM methodologies to translate risks into sustainable operational controls.
Provide subject matter expertise and support for critical site projects as required.
Cross-Functional Collaboration:
Partner cross-functionally (Operations, MSAT, QA, QC, Engineering) and with global leaders to harmonize standards and drive transformation.
Provide technical and organizational leadership to foster a proactive, risk-based quality culture.
Mentor and upskill the organization to enhance self-identification of risks and promote a culture of proactive issue resolution.
Core Quality Compliance Support
Serve as the site Subject Matter Expert (SME) for digital regulatory requirements and inspection commitments, assessing compliance status and leading remediation action plans.
Provide support to core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
Support key compliance processes, including Quality Escalations, Recalls, Inspection Management, Self-Inspections, Site Master File, Management Reviews, Supplier Management, and Health Authority engagement.
Bachelor's degree in a scientific/technical discipline (Advanced degree preferred).
Minimum 8–10 years in a GxP environment, with at least 4 years leading strategic quality improvement projects in manufacturing and/or QC environments.
Deep expertise in global GxP regulations (FDA, EMA, ICH, ISO) and their application in digital, sterile manufacturing and device packaging environments.
Extensive experience assessing Annex 4 and Annex 11 compliance in highly automated environments.
Proven ability to translate Data Integrity and QRM methodologies into robust operational controls for drug and combination products.
Experience with defining controls and governance associated with the use of Artificial Intelligence (Annex 22) preferred.
Track record of leading cross-functional teams to deliver strategic quality improvements.
Demonstrated success developing, implementing, or auditing site-wide Data Integrity programs within highly automated or digital footprints.
Broad experience across Quality and operations preferred.
Extensive experience with regulatory inspections and health authority interactions.
Strong collaborator skilled at proactively communicating quality risk and fostering a transparent, solution-oriented culture.
Exceptional ability to influence stakeholders, site teams, and global leaders without formal authority.
Thrives in ambiguity, challenges the status quo, and leverages Lean/Six Sigma to drive operational rigor.
Adaptable in dynamic, fast-paced environments while maintaining high-quality and safety standards.
Relocation assistance is available for this role.
The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $114,700 - $212,900. 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.
Link to 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.
About Genentech We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours. If you’d like to join our team, view our openings at gene.com/careers. Our patient resource center is dedicated to getting patients and caregivers to the right resources. You can reach them at 1 (877) GENENTECH (436-3683) Monday-Friday, 6am-5pm PST or [email protected]. Community Guidelines: 1. We want to foster positive conversation around the issues we are passionate about. To that end, we remove profanity, content that contains threatening language, content that is aimed at private individuals, personal information, and repeated unwanted messages. 2. Don’t mention any medicines by name — ours or anyone else’s. Because of the fair balance rules governing our industry, we cannot post any comments that reference any pharmaceutical brand, product, or service. Please do not mention any specific medicines by name, or include any links to third party sites in your comments. 3. This isn’t the place to report or discuss side effects. This site is not intended as a forum for reporting side effects experienced while taking a Genentech product. Instead, you should report any side effects to Genentech Drug Safety at 1-888-835-2555. You can also report side effects of any prescription product directly to the FDA at 1-800-FDA-1088 or by visiting www.FDA.gov/medwatch. 4. Don’t pitch your product or service. Please don't use our page as a place to promote your product or pitch your services. Please also avoid posting links to external sites. We reserve the right to remove any posts that are deemed promotional.
Offices: 1 Dna Way, South San Francisco, California 94080, US · 1000 New Horizons Way, Vacaville, California 95688, US · 1 Antibody Way, Oceanside, California 92056, US · 4625 NE Brookwood Pkwy, Hillsboro, Oregon 97124, US
About Genentech We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours. If you’d like to join our team, view our openings at gene.com/careers. Our patient resource center is dedicated to getting patients and caregivers to the right resources. You can reach them at 1 (877) GENENTECH (436-3683) Monday-Friday, 6am-5pm PST or [email protected]. Community Guidelines: 1. We want to foster positive conversation around the issues we are passionate about. To that end, we remove profanity, content that contains threatening language, content that is aimed at private individuals, personal information, and repeated unwanted messages. 2. Don’t mention any medicines by name — ours or anyone else’s. Because of the fair balance rules governing our industry, we cannot post any comments that reference any pharmaceutical brand, product, or service. Please do not mention any specific medicines by name, or include any links to third party sites in your comments. 3. This isn’t the place to report or discuss side effects. This site is not intended as a forum for reporting side effects experienced while taking a Genentech product. Instead, you should report any side effects to Genentech Drug Safety at 1-888-835-2555. You can also report side effects of any prescription product directly to the FDA at 1-800-FDA-1088 or by visiting www.FDA.gov/medwatch. 4. Don’t pitch your product or service. Please don't use our page as a place to promote your product or pitch your services. Please also avoid posting links to external sites. We reserve the right to remove any posts that are deemed promotional.
Offices: 1 Dna Way, South San Francisco, California 94080, US · 1000 New Horizons Way, Vacaville, California 95688, US · 1 Antibody Way, Oceanside, California 92056, US · 4625 NE Brookwood Pkwy, Hillsboro, Oregon 97124, US
