The Opportunity:

The Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our QC Microbiology 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 core QC capabilities to support facility, utility, and process qualifications—before pivoting to routine commercial operations following site licensure.

Leadership:

• You will 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. 

• 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 ensure appropriate staffing, resource allocation, and workload balancing to support business priorities and changing operational demands

• 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 use data-driven decision making to identify trends, mitigate risks, and improve operational performance.

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

• You are experienced in presenting Microbiology 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 Microbiology methods, laboratory instrumentation, and analytical method validation, qualification, and transfer within the pharmaceutical or biopharmaceutical industry.

• You have extensive experience in contamination control strategies, environmental and utility system monitoring. 

• 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.

• 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 $120,100 - $223,100. 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.

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