Nephron Pharmaceuticals · 3 weeks ago
Director of Quality Operations
West Columbia, SC
Full-time
Onsite
Director/Executive
10+ years expNephron Pharmaceuticals is seeking a Director of Quality Operations to provide strategic and operational leadership for Quality Operations in aseptic manufacturing. The role involves ensuring compliance with FDA regulations, overseeing quality systems, and leading a high-performing Quality Operations team while partnering cross-functionally to maintain efficient operations.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
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
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
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
Company
Nephron Pharmaceuticals
Nephron Pharmaceuticals Corporation is a mid-sized company that manufactures generic respiratory medications.
501-1000 employees
H1B Sponsorship
Nephron Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$775MKey Investors
WhiteHawk Capital Partners
2025-01-10Debt Financing· $350M
2023-09-15Private Equity· $350M
2014-08-07Debt Financing· $75M
Leadership Team
B
Bryan Beck
Chief Technology Officer
A
Ashley Daugherty
Chief Scientific Officer
Recent News
PR Newswire UK
2025-10-20
Company data provided by crunchbase