What are the responsibilities and job description for the Director of Quality position at McGuff Companies?
About McGuff Pharmaceuticals, Inc.
McGuff Pharmaceuticals, Inc. (MPI) is a family-owned, FDA-inspected sterile pharmaceutical manufacturer supported by over 45 years of operational excellence through the McGuff family of companies. Our integrated organization includes:
• McGuff Pharmaceuticals, Inc. – FDA-registered manufacturer of sterile injectable NDA and ANDA products
• McGuff Outsourcing Services (503B) – Outsourcing facility serving hospital systems and private practices
• McGuff Medical Products – Licensed nationwide pharmaceutical and medical products wholesaler
Operating from a modern Southern California facility with in-house chemistry and microbiology laboratories, MPI distributes products nationally and internationally and continues to expand its sterile manufacturing and CDMO capabilities.
Position Overview
McGuff Pharmaceuticals is establishing a new executive leadership position — Director of Quality — to strengthen and scale the Quality organization in alignment with company growth across sterile manufacturing, 503B operations, and CDMO services.
This position reports directly to the CEO/President, ensuring full independence of the Quality function and clear executive authority over regulatory compliance, product release, and quality risk management.
The Director of Quality has full leadership responsibility over the Quality organization. The QA Manager, QC Manager, and Quality Engineering & Validation (QEV) Manager report directly to this position.
This role is responsible for building a culture of disciplined execution, continuous inspection readiness, technical excellence, and mentorship-driven leadership development.
Core Responsibilities
Executive Quality Leadership
• Serve as the senior Quality authority across all regulated entities.
• Lead and develop the QA, QC, and QEV management team.
• Establish and communicate a clear quality vision aligned with business growth and regulatory expectations.
• Maintain independent authority over batch release, material disposition, and compliance decisions.
• Provide regular executive reporting on compliance status, quality metrics, and regulatory risk.
Inspection Readiness & Regulatory Governance
• Establish and maintain a culture of perpetual inspection readiness.
• Lead FDA, State Board of Pharmacy, and third-party inspections.
• Ensure systems, documentation, training, and facilities are audit-ready at all times.
• Strengthen internal audit programs and ensure effective CAPA implementation.
• Proactively identify compliance vulnerabilities and implement preventive controls.
• Ensure full compliance with 21 CFR Parts 210, 211, and 11; 503B guidance; USP standards; and applicable state regulations.
Inspection readiness is treated as an operating discipline, not an event.
Quality Assurance Oversight
• Oversee batch record review, deviation investigations, change control, CAPA systems, complaint management, and final product release.
• Drive disciplined documentation practices and right-first-time execution.
• Ensure strong data integrity governance aligned with ALCOA principles.
• Continuously improve the electronic Quality Management System (eQMS).
Quality Control & Laboratory Leadership
• Provide executive oversight of analytical chemistry and microbiology laboratories.
• Ensure scientific rigor in environmental monitoring, sterility testing, method validation, and release testing.
• Strengthen coordination between QC, Manufacturing, and Engineering to support growth and scalability.
Quality Engineering & Validation
• Oversee validation strategy, including process validation, cleaning validation, equipment qualification, and facility qualification.
• Ensure technical decisions are scientifically sound and regulatory defensible.
• Align validation strategy with expansion and capacity planning initiatives.
Mentorship & Organizational Development
• Build and mentor a technically strong, disciplined quality organization.
• Develop future quality leaders through structured coaching and succession planning.
• Elevate managerial capability within QA, QC, and Validation teams.
• Strengthen regulatory knowledge and quality ownership across departments.
• Foster a culture of accountability, transparency, and continuous improvement.
Developing people and strengthening leadership depth are core expectations of this role.
Technology & Continuous Improvement
• Evaluate and implement digital systems and analytical tools that enhance data visibility, compliance oversight, and risk detection.
• Use data-driven insights to improve robustness without compromising regulatory standards.
• Modernize quality infrastructure to support sustainable growth.
Required Qualifications
• 12 years of progressive experience in FDA-regulated sterile pharmaceutical manufacturing.
• Minimum 5 years in senior leadership overseeing QA and QC functions.
• Direct experience leading and supporting FDA inspections.
• Deep expertise in aseptic processing, environmental monitoring, data integrity, and cGMP systems.
• Demonstrated success building and mentoring high-performing teams.
• Strong regulatory judgment and risk management capability.
Preferred Experience
• 503B outsourcing facility experience.
• CDMO or contract manufacturing background.
• Experience integrating ERP, LIMS, and electronic QMS platforms.
• Advanced degree in a scientific discipline (MS, PharmD, or PhD preferred).
Leadership Profile
The ideal candidate is:
• Inspection-ready by discipline and confident under regulatory scrutiny.
• A committed mentor who develops managers into leaders.
• Strategically focused yet operationally grounded.
• Independent, principled, and decisive.
• Collaborative while maintaining firm quality authority.
Why This Role Is Unique
• Newly created executive position with direct CEO/President reporting.
• Direct oversight of QA, QC, and QEV leadership.
• Full authority to shape the Quality organization’s structure and systems.
• Significant executive visibility and impact within a growing sterile pharmaceutical enterprise.
• Opportunity to build a durable, inspection-ready quality culture.
Application Process
Qualified candidates should submit a resume and cover letter to: employment.MPI@mcguff.com
All inquiries will be handled confidentially.