Senior Manager, QC Chemistry and Device Testing (CVRM)

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:

The Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our QC Chemistry and Device Testing team.

In this critical role you will build a highly effective and engaged organization capable of delivering safe compliant and efficient testing for our CVRM (Cardiovascular Renal and Metabolism) products manufactured at the Holly Springs site. Initially you will focus on laboratory start-up activitiesestablishing core QC capabilities to support facility utility and process qualificationsbefore pivoting to routine commercial operations following site licensure.

Leadership:

• You will champion a proactive quality culture built on psychological safety and transparent communicationempowering your team to speak up simplify processes and take personal accountability for owning quality.

• You will drive a proactive safety culture by fostering Behavior-Based Safety (BBS) principles and ensuring strict compliance with site safety processes and regulatory standards.

• You will foster a high-performing engaged lab culture by practicing Lean Leadership providing active coaching and embedding continuous improvement into daily operations.

• You will partner with the global network to harmonize QC standards and ensure seamless execution and compliance across site operations.

Technical and functional tasks:

• You will establish key operational performance measures (KPIs) with a focus on Compliance Right-First-Time (RFT) execution and continuous improvement to meet business objectives.

• You will author review and approve critical technical scientific and compliance documents (e.g. test methods validation protocols SOPs).

• You will own Quality Management System (QMS) records including investigations deviations CAPAs and change controls. .

• You will participate in the identification evaluation and implementation of new technologies in alignment with business objectives or regulatory requirements.

• You will have responsibility for strategic projects to support execution of QC network strategy.

• You are experienced in presenting QC topics during regulatory inspections and maintaining a continuous state of audit readiness across QC operations.

Who you are:

• You hold a B.S. or M.S. degree (Science related discipline) with a minimum of 8 years of experience in pharmaceutical or biopharmaceutical manufacturing. This includes at least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site.

• You have extensive technical knowledge of analytical methods laboratory instrumentation and analytical method validation qualification and transfer within the pharmaceutical or biopharmaceutical industry.

• You have in-depth working knowledge of cGMP operations ICH guidelines and global Health Authority regulatory requirements (FDA EMA etc.).

• You have proven technical leadership capabilities and demonstrated project management skills with a track record of effectively managing workload distribution timelines and competing priorities.

• You have exceptional communication skills with the demonstrated ability to inspire motivate and coach a team while collaborating effectively with internal cross-functional groups global partners suppliers and external customers.

• You have proven experience managing operational and capital budgets (OpEx/CapEx) with a track record of driving cost-efficient laboratory operations and resource optimization.

Preferred:

• Experience in a greenfield project.

• Hands-on knowledge or oversight of Medical Device Functionality testing (e.g. autoinjectors pen injectors).

• Formal Operational Excellence certification (e.g. Lean Six Sigma Green/Black Belt 5S Kaizen).

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 $120100 - $223100. 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.