Senior Manager of Manufacturing

About the Role The Senior Manager of Manufacturing will lead day-to-day operations for the commercial aseptic manufacturing of drug and device products, overseeing departments such as Compounding, Equipment/Component Preparation, Sterile Filling, Inspection and Packaging. You will ensure SOP compliance and data integrity for GMP processes, and meet regulatory requirements (FDA, OSHA, OFCCP, EPA, etc.). What You'll Do

• Lead daily manufacturing operations across one or multiple value streams, aligning with production schedules and quality expectations.
• Provide leadership and technical guidance to manufacturing personnel to foster a collaborative, innovative culture focused on operational excellence, quality, safety, customer satisfaction, and financial goals.
• Develop and coach both non-exempt and exempt staff, including process supervisors; recruit aligned with strategic direction and support ongoing feedback and leadership development.
• Drive continuous improvement, identify opportunities to optimize processes, and act as a change agent with cross-functional teams.
• Ensure compliance with regulatory requirements, EH&S SOPs, and maintain inspection readiness; participate in audits; manage CAPAs and investigations; maintain QMS documentation and change controls.
• Interface with customers and regulatory personnel during audits, ensure on-time delivery, escalate issues as needed, and lead project scheduling and status updates.
• Monitor performance metrics (e.g., profitability and efficiency goals) and work to maximize OEE, yield, minimize downtime, and reduce WIP in adherence with cost discipline. What We're Looking For
• Demonstrated leadership and experience in manufacturing operations, preferably in aseptic drug/product manufacturing with a strong track record of regulatory compliance and quality systems (CAPA, change control, investigations).
• Ability to manage multiple departments and coordinate cross-functional teams; strong communication, problem-solving, and project management skills.
• Knowledge of GMP, FDA, OSHA, OFCCP, EPA requirements and quality systems; experience supporting audits and inspections.
• Commitment to safety, data integrity, and continuous improvement; ability to drive a culture of performance and accountability.