Sr Manager/Director, Validation , CVRM (Holly Springs)

Genentech • Cary, NC

1d • Hybrid

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.

We're seeking a highly skilled and experienced Head of Validation who will oversee the overall equipment qualification and end-to-end process validation strategy at the Holly Springs site, from plant start-up and launch through ongoing operations to ensure compliance with Roche standards, regulatory requirements while enabling efficient operations and business needs. This role will provide strategic and technical support to Quality, operations, network functions, and project teams to ensure the implementation of the validation lifecycle for products, equipment, facilities and utilities to deliver robust and contemporary manufacturing processes end-to-end.
Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.

Requirements

• BS/MS in chemical, biochemical engineering, or related field/experience.
• You have 15 years of work experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment with Process Research & Development, Engineering, Manufacturing, or Technical Services in a GMP environment (preferably drug product)
• You have extensive knowledge of cGMPs or equivalent regulations (ICH, FDA, EMA, USP/EP, Health Canada regulations, policies & guidelines) with a strong understanding of the regulatory requirements specific to aseptic processing.
• You have an ability to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
• You have strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources. Is able to coach others.
• You have a demonstrated ability for planning validation activities working collaboratively with cross-functional teams, including development, operations, quality assurance, automation engineering, and maintenance.
• This position is eligible for relocation benefits.

Responsibilities

• You will lead the validation lifecycle management and overall Validation strategy for all Holly Springs products, equipment, facilities, utilities, and processes.
• You will provide guidance and lead the management of validation lifecycle for all products, equipment, facilities and utilities, including IQ/OQ/PQ, cleaning validation, requalification/revalidation, and process validation. You will continuously evaluate the validation program and establish validation policies, procedures and training to ensure continued compliance with company standards and current regulatory requirements.
• You will ensure current plant startup and launch products and future product portfolio needs are embedded into the validation strategy. You will proactively identify and manage risks to current and future operations through a robust and contemporary validation program. Support regulatory submissions, as well as Health Authority inspections and audits.
• You will develop and lead a high performance team responsible for the validation lifecycle program, manage the recruitment, training and development of staff. You will assign validation resources to ensure that adequate and qualified personnel staff is available to perform and/or lead ongoing and project driven validation activities.
• You will ensure the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents within one’s functional area. Fosters a safe and compliant speak up culture. Actively build, support, and promote a culture of continuous improvement and learning from both successes and failures.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager