Position Summary
The
Director of Quality Operations
provides direct support for all Manufacturing and Quality activities. This position supports the Quality Operations across multiple shifts to oversee all quality aspects within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for finished pharmaceuticals and Active Pharmaceutical Ingredients (API).
Job Responsibilities
Directing the day-to-day responsibilities and duties of personnel including:
Manufacturing/Quality Assurance Liaisons (MQAs)
Scientific/Quality Assurance Liaisons (SQAs)
Provide leadership, and developmental opportunities
Review relevant Investigations, Change Control, and CAPA(s)
Work with Area Management to drive Quality Culture
Providing Quality Assurance oversight in the Sterile production processes, including:
Maintaining a Quality presence in warehouse, dispensing, and manufacturing areas
Support validation and qualification activities
Perform Spot-Check Data Reviews
Change Control Process
Internal Process Observation Responses
Providing management oversight for Development Batches and for API Synthesis including:
Production Auditing
Documentation Review
Communication liaisons to plan, prepare, and execute development products and PPQ batches.
Trending of Quality metrics
Focusing on mentoring, process excellence, and execution
Sustain Quality Systems to ensure no critical complaints or regulatory actions
Provide support for the Internal Audit Program
Performs other duties as assigned
Experience Requirements
Strong critical thinking skills and business acumen
Advise internal and external stakeholders on interpretation and compliance with Regulatory Guidelines, Company Policies, and Standard Operation Procedures.
Must be able to read and write English, possess technical writing skills, perform mathematical calculations, write and follow scientific terminology and notation.
Must be able to follow instructions, attend to details, multi-task, and handle multiple priorities without undue stress or errors.
Must have computer skills including MS Outlook, and be proficient using MS Word and MS Excel.
Must be able to sit and/or stand for extended periods of time,
Must be able to climb stairs, must be able to lift and carry 25 lbs, and walk while carrying items
Must be able to see very small print and tiny graduations.
Education Requirements
Bachelor's Degree in a scientific discipline required and A minimum of ten (10) years working experience in the pharmaceutical manufacturing industry or healthcare industry
Required , In addition a minimum of five (5) years prior management experience
Preferred .
EOE, including disability/vets.
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