Principal Quality Compliance Specialist, CVRM (Holly Springs)

Welcome to Holly Springs North Carolina home to Roche/Genentechs 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 facilitys 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 todays 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 wont just build a plantyou will build the future of medicine.

The Opportunity

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 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 Roches 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 sites 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 Youll 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.

Who You Are

• Bachelors degree in a scientific/technical discipline (Advanced degree preferred).

• Minimum 810 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 $114700 - $212900. 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 companys 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.