Senior Quality Compliance Specialist, CVRM (Holly Springs)
Genentech
Senior Quality Compliance Specialist, CVRM (Holly Springs)
Job Description
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.The OpportunityWe are looking for a highly impactful Senior Quality Compliance Specialist with broad experience, a robust risk-based operational focus, and a strong compliance mindset. This critical role is essential for guaranteeing the integration of risk based principles and data integrity controls into the operational design of our processes to deliver top-quality products, consistently meeting global regulatory requirements and Roche's stringent internal standards.As a key member of the Quality Compliance team, you will hold strategic responsibility for the comprehensive design and implementation of the site's Quality Risk Management and Data Integrity initiatives. You will work in tandem with a variety of cross-functional partners, including Engineering, MSAT, Warehouse, Operations, Quality, QC, and Global organizations, to proactively identify and address risks, establishing a robust, risk-oriented Quality Culture throughout the site.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 Quality Risk Management (QRM)Serve as the premier site expert in QRM, actively facilitating complex risk assessments and translating risk-based data into sustainable operational controls.Apply advanced proficiency in QRM methodologies (e.g., FMEA, PHA) and risk-based decision-making to complex operational challenges.Lead or support risk assessments and change control activities, particularly for high-impact processes.Owner of the site risk register and lifecycle management of risk assessments.Data IntegrityTake full ownership of the site Data Integrity program, ensuring all automated, digital, and analytical systems comply with internal standards and global regulations.Coordinate and lead targeted deep-dive assessments focusing on data integrity elements. Identify and assess risks, integrating risk-based controls into the operational design of recipes, analytical methods and associated procedures.Establish the site data integrity cultural program and integrate into the site ramp up strategy. Change ControlServe as site subject matter expert for change control.Chair the site Change Review Board, providing cross-functional leadership to evaluate, challenge, and approve high-impact modifications during commissioning, validation, and commercial phases.Drive consistent execution of the change control program.Core Quality Compliance Support Partners cross-functionally to drive a proactive, risk-based quality culture providing technical and organizational leadership toward resolving compliance issues.Provide oversight of core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.Support compliance processes, including Quality Escalations, Product Recalls, Inspection Management, Self inspection, the Site Master File, Management Review, Supplier Management and Metrics & Reporting.Support compliance processes, including Quality Escalations, Product Recalls, Inspection Management, Self inspection, the Site Master File, Management Review, Supplier Management, Metrics & Reporting and Health Authority engagement..Serves as subject matter expert on global regulated requirements and inspectional commitments, assessing the state of compliance and participation in the action plans to correct deficiencies.Serve as the site contact to engage with global stakeholders regarding compliance trends, knowledge sharing and improvement initiatives. Who You AreBachelor's degree in a scientific/technical discipline (Advanced degree preferred).Minimum of 8–10 years in a GxP environment, with at least 4 years of accumulated experience in leading QRM, Data Integrity or Change Control programs at a manufacturing site. Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and their practical application in a digital manufacturing landscape for sterile drug product manufacturing and device assembly and packaging.Experienced with the translation of QRM methodologies into operational controls for drug and combination products. Demonstrated success developing, implementing, or auditing site-wide Data Integrity compliance programs within highly automated/digital facility footprints.Broad experience across Quality and/or operations preferred. Extensive experience with regulatory inspections and health authority interactions.Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue.You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.Relocation Assistance is available for this role. The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $94,000 - $174,600. Actual pay will be determined based on experience, 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.BenefitsGenentech 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.
Locations
- Holly Springs
Salary
94,000 - 174,600 USD / yearly
Skills Required
- leading QRMintermediate
- global GxP regulationsintermediate
- regulatory inspectionsintermediate
Required Qualifications
- Bachelor's degree in a scientific/technical discipline (Advanced degree preferred). (degree in a scientific)
- Minimum of 8–10 years in a GxP environment, with at least 4 years of accumulated experience in leading QRM, Data Integrity or Change Control programs at a manufacturing site. (experience, 10 years)
- Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and their practical application in a digital manufacturing landscape for sterile drug product manufacturing and device assembly and packaging. (experience)
- Experienced with the translation of QRM methodologies into operational controls for drug and combination products. (experience)
- Demonstrated success developing, implementing, or auditing site-wide Data Integrity compliance programs within highly automated/digital facility footprints. (experience)
- Broad experience across Quality and/or operations preferred. (experience)
- Extensive experience with regulatory inspections and health authority interactions. (experience)
- Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue. (experience)
- You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards. (experience)
- Bachelor's degree in a scientific/technical discipline (Advanced degree preferred). (degree in a scientific)
- Minimum of 8–10 years in a GxP environment, with at least 4 years of accumulated experience in leading QRM, Data Integrity or Change Control programs at a manufacturing site. (experience, 10 years)
- Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and their practical application in a digital manufacturing landscape for sterile drug product manufacturing and device assembly and packaging. (experience)
- Experienced with the translation of QRM methodologies into operational controls for drug and combination products. (experience)
- Demonstrated success developing, implementing, or auditing site-wide Data Integrity compliance programs within highly automated/digital facility footprints. (experience)
- Broad experience across Quality and/or operations preferred. (experience)
- Extensive experience with regulatory inspections and health authority interactions. (experience)
- Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue. (experience)
- You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards. (experience)
Responsibilities
- Quality Risk Management (QRM)Serve as the premier site expert in QRM, actively facilitating complex risk assessments and translating risk-based data into sustainable operational controls.Apply advanced proficiency in QRM methodologies (e.g., FMEA, PHA) and risk-based decision-making to complex operational challenges.Lead or support risk assessments and change control activities, particularly for high-impact processes.Owner of the site risk register and lifecycle management of risk assessments.
- Quality Risk Management (QRM)
- Serve as the premier site expert in QRM, actively facilitating complex risk assessments and translating risk-based data into sustainable operational controls.
- Apply advanced proficiency in QRM methodologies (e.g., FMEA, PHA) and risk-based decision-making to complex operational challenges.
- Lead or support risk assessments and change control activities, particularly for high-impact processes.
- Owner of the site risk register and lifecycle management of risk assessments.
- Data IntegrityTake full ownership of the site Data Integrity program, ensuring all automated, digital, and analytical systems comply with internal standards and global regulations.Coordinate and lead targeted deep-dive assessments focusing on data integrity elements. Identify and assess risks, integrating risk-based controls into the operational design of recipes, analytical methods and associated procedures.Establish the site data integrity cultural program and integrate into the site ramp up strategy.
- Take full ownership of the site Data Integrity program, ensuring all automated, digital, and analytical systems comply with internal standards and global regulations.
- Coordinate and lead targeted deep-dive assessments focusing on data integrity elements. Identify and assess risks, integrating risk-based controls into the operational design of recipes, analytical methods and associated procedures.
- Establish the site data integrity cultural program and integrate into the site ramp up strategy.
- Change Control
- Serve as site subject matter expert for change control.
- Chair the site Change Review Board, providing cross-functional leadership to evaluate, challenge, and approve high-impact modifications during commissioning, validation, and commercial phases.
- Drive consistent execution of the change control program.
- Serve as site subject matter expert for change control.
- Chair the site Change Review Board, providing cross-functional leadership to evaluate, challenge, and approve high-impact modifications during commissioning, validation, and commercial phases.
- Drive consistent execution of the change control program.
- Core Quality Compliance Support
- Core Quality Compliance Support
- Partners cross-functionally to drive a proactive, risk-based quality culture providing technical and organizational leadership toward resolving compliance issues.
- Provide oversight of core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
- Support compliance processes, including Quality Escalations, Product Recalls, Inspection Management, Self inspection, the Site Master File, Management Review, Supplier Management and Metrics & Reporting.
- Support compliance processes, including Quality Escalations, Product Recalls, Inspection Management, Self inspection, the Site Master File, Management Review, Supplier Management, Metrics & Reporting and Health Authority engagement..
- Serves as subject matter expert on global regulated requirements and inspectional commitments, assessing the state of compliance and participation in the action plans to correct deficiencies.
- Serve as the site contact to engage with global stakeholders regarding compliance trends, knowledge sharing and improvement initiatives.
- Partners cross-functionally to drive a proactive, risk-based quality culture providing technical and organizational leadership toward resolving compliance issues.
- Provide oversight of core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
- Support compliance processes, including Quality Escalations, Product Recalls, Inspection Management, Self inspection, the Site Master File, Management Review, Supplier Management and Metrics & Reporting.
- Support compliance processes, including Quality Escalations, Product Recalls, Inspection Management, Self inspection, the Site Master File, Management Review, Supplier Management, Metrics & Reporting and Health Authority engagement..
- Serves as subject matter expert on global regulated requirements and inspectional commitments, assessing the state of compliance and participation in the action plans to correct deficiencies.
- Serve as the site contact to engage with global stakeholders regarding compliance trends, knowledge sharing and improvement initiatives.
Benefits
- general: 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.
- general: 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.
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