Senior Manager, Analytical Sciences and Technology, CVRM
About 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 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 Opportunity: The Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our Analytical Sciences and Technology 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 activities—establishing QC methods to support facility, utility, and process qualifications—before pivoting to method lifecycle management and ongoing support of routine QC operations to include QC Quality records and stability/sampling.
Requirements
- Hold a B.S. or M.S. degree (Science related discipline) with a minimum of 8 years of experience in pharmaceutical or biopharmaceutical manufacturing.
- At least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site.
- Extensive technical knowledge of analytical methods, laboratory instrumentation, with proven experience in analytical method validation, qualification, and transfer within the pharmaceutical or biopharmaceutical industry.
- Experience in stability program ownership for a commercial manufacturing site.
- In-depth working knowledge of cGMP operations, ICH guidelines, and global Health Authority regulatory requirements (FDA, EMA, etc.).
- Proven technical leadership capabilities and demonstrated project management skills, with a track record of effectively managing workload distribution, timelines, and competing priorities.
- 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.
- Extensive experience in deviation investigation.
Nice To Haves
- Experience in a greenfield project.
- Hands-on knowledge or oversight of Medical Device Functionality testing (e.g., autoinjectors, pen injectors).
- Experience in both Physical Chemistry and Microbiological Method Lifecycle Management.
- Experience in method establishment and oversight at contract testing laboratories.
Responsibilities
- Champion a proactive quality culture built on psychological safety and transparent communication—empowering your team to speak up, simplify processes, and take personal accountability for owning quality.
- Drive a proactive safety culture by fostering Behavior-Based Safety (BBS) principles and ensuring strict compliance with site safety processes and regulatory standards.
- Foster a high-performing, engaged lab culture by practicing Lean Leadership, providing active coaching, and embedding continuous improvement into daily operations.
- Partner with the global network to harmonize QC standards and ensure seamless execution and compliance across site operations.
- Author, review, and approve critical technical, scientific, and compliance documents (e.g., test methods, validation/stability protocols, SOPs).
- Establish key operational performance measures (KPIs) with a focus on Compliance, Right-First-Time (RFT) execution and continuous improvement to meet business objectives.
- Own Quality Management System (QMS) records, including investigations, deviations, CAPAs, and change controls.
- Participate in the identification, evaluation, and implementation of new technologies in alignment with business objectives or regulatory requirements.
- Have responsibility for strategic projects to support execution of QC network strategy.
- Be experienced in presenting QC topics during regulatory inspections and maintaining a continuous state of audit readiness across QC operations.
Benefits
- Relocation assistance is available for this role.
- A discretionary annual bonus may be available based on individual and Company performance.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
