Description

Job Purpose:

Provide strategic and operational leadership for Quality Operations supporting aseptic manufacturing, including Blow-Fill-Seal (BFS) and conventional sterile filling processes. Ensure full compliance with FDA 503B regulations, cGMP requirements, and applicable regulatory standards by establishing, maintaining, and continuously improving robust Quality Systems. Oversee quality oversight of facilities, utilities, equipment, and environmental monitoring programs to ensure sterility assurance and a sustained state of control. Lead and develop a high-performing Quality Operations organization, fostering a strong culture of quality, data integrity, inspection readiness, and continuous improvement. Partner cross-functionally with Manufacturing, Engineering, and Supply Chain to enable compliant, efficient operations, ensure uninterrupted supply, and serve as the primary Quality representative during regulatory inspections and audits.

Essential Duties and Responsibilities: 

· Provide Quality Operations leadership for aseptic manufacturing, including Blow-Fill-Seal (BFS), conventional sterile filling, visual inspection, and secondary packaging operations.

· Ensure compliance with FDA 503B regulations, cGMP requirements, and data integrity standards across all manufacturing and quality activities.

· Own and maintain site Quality Systems, including deviations, investigations, CAPA, change control, complaints, and document control.

· Provide Quality oversight and approval for batch record review, product disposition, validation activities, and aseptic process controls.

· Support sterility assurance programs, including environmental and utilities monitoring, contamination control strategy, and aseptic process simulations.

· Lead inspection readiness and serve as the primary Quality representative during FDA, customer, and regulatory audits.

· Partner with Manufacturing, Engineering, and Technical Services to support equipment qualification, process changes, capital projects, and technology transfers impacting filling, inspection, and packaging operations.

· Lead, develop, and mentor the Quality Operations team while driving a strong culture of quality, compliance, and continuous improvement.

· Oversee Quality review and approval of facilities, utilities, and equipment qualification, calibration, maintenance, and lifecycle management activities.

· Establish and monitor Quality metrics and KPIs to assess performance, identify trends, and drive continuous improvement initiatives.

· Lead, coach, and develop the Quality Operations team, ensuring appropriate staffing, training, and succession planning.

· Ensure effective supplier quality management, including qualification, audits, and oversight of critical vendors and contract service providers.

· Review and approve procedures, protocols, reports, and quality agreements to ensure regulatory compliance and operational alignment.

· Drive a culture of quality, accountability, and continuous improvement across the site.

· Escalate quality risks appropriately and ensure timely, effective mitigation to protect patient safety and product quality.

Knowledge & Skills:

• Comprehensive understanding of FDA      regulatory frameworks covering both 503B Outsourcing Facility requirements      and cGMP operations, including 21 CFR Parts 210/211 and applicable      guidance documents.
• Strong expertise in sterility assurance,      aseptic processing, environmental monitoring, and contamination control      strategies within sterile manufacturing, visual inspection, and secondary      packaging.
• Experience leading FDA inspections,      regulatory audits, and customer audits, with strong inspection readiness      and response capabilities.
• Proven ability to apply quality risk      management principles and data-driven decision-making to ensure product      quality and patient safety.
• Strong leadership, coaching, and      organizational development skills, with the ability to build and sustain      high-performing Quality teams.
• Effective cross-functional collaboration      skills, partnering with Manufacturing, Engineering, Technical Services,      and Supply Chain.
• Experience with change control, deviation      investigations, and CAPA systems within a GMP-regulated manufacturing      environment.
• Experience with quality approval for      process validation and equipment qualification (IQ/OQ/PQ), media fills,      cleaning validation, and lifecycle process management.
• Proficiency with quality metrics, KPIs, and      continuous improvement methodologies to drive compliance and operational      excellence.
• Strong leadership capabilities with      experience coaching and developing high-performing teams across operations      and quality. 
• Prior experience supporting regulatory      inspections (FDA, state board of pharmacy, or third-party audits).
• Must be detailed oriented and have      excellent organizational skills.
• Must have excellent communication and      technical writing skills.
• Ability to drive continuous improvement      initiatives while maintaining regulatory compliance and quality standards.
• Strong organizational skills with the      ability to manage multiple priorities in a fast-paced, regulated      environment.

Education/Experience: 

• Bachelor's degree in Engineering, Life      Sciences, Pharmacy, Chemistry, or a related scientific/technical      discipline required.
• Minimum of 10+ years of progressive      experience in Quality Assurance / Quality Operations within a      cGMP-regulated pharmaceutical or biotechnology environment.
• At least 5+ years of leadership experience      managing Quality teams supporting sterile manufacturing operations.
• Hands-on experience with aseptic      processing, visual inspection, and secondary packaging.
• Proven experience overseeing Quality      Systems such as deviations, investigations, CAPA, change control, and      document control.
• Experience supporting equipment      qualification, process validation, environmental monitoring, and sterility      assurance programs.
• Strong background in inspection readiness,      audit management, and regulatory interactions.
• Hands-on experience supporting FDA      inspections, regulatory audits, and responses to inspection observations      (e.g., FDA Form 483).
• Strong background in operational      excellence, continuous improvement, and performance management.
• Demonstrated ability to lead      cross-functional teams while maintaining Quality unit independence and      regulatory compliance.
• Salary Range: Based on experience

Working Conditions / Physical Requirements:

• Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing. 

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