Summary:
The Head of Production (Sterile Injectables) is responsible for providing strategic and operational leadership for all aspects of sterile manufacturing operations. This role ensures compliance with cGMP regulations, drives operational excellence, and leads high-performing teams to achieve manufacturing objectives in a regulated environment.
Responsibilities:
- Direct and oversee all sterile manufacturing operations, including component preparation, formulation, compounding, aseptic filling, visual inspection, and packaging.
- Develop and implement production strategies to achieve manufacturing goals, supply commitments, and performance targets.
- Ensure all manufacturing activities adhere to cGMP regulations, internal quality systems, and regulatory requirements for sterile drug products.
- Maintain a continuous state of audit readiness and support regulatory inspections, internal audits, and customer audits.
- Lead and manage investigations, deviations, CAPAs, and change control processes impacting production operations.
- Establish, monitor, and report on key performance indicators (KPIs) related to safety, quality, delivery, and productivity to drive accountability and improvement.
- Champion operational excellence initiatives to enhance manufacturing efficiency, reduce waste, and improve process reliability.
- Build, develop, and lead high-performing production teams, fostering a culture of compliance, safety, and continuous improvement.
Qualifications:
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field required; Master’s degree preferred.
- 8–15 years of progressive experience in pharmaceutical manufacturing operations within a regulated cGMP environment.
- 5–12 years of leadership experience in sterile or aseptic pharmaceutical manufacturing settings.
- Proven experience overseeing operations such as formulation, compounding, aseptic filling, visual inspection, and/or packaging of pharmaceuticals.
- Strong knowledge of FDA cGMP regulations and regulatory expectations for sterile drug product manufacturing.
- Experience supporting regulatory inspections and maintaining audit-ready operations.
- Demonstrated ability to lead investigations, manage deviations, CAPAs, and change control activities.
- Proven leadership skills with experience developing and managing production teams in regulated environments.
