Position Summary:

The Executive Director of Quality provides direct support for all Manufacturing and Quality activities. They will be responsible for developing and leading the overall quality strategy for the organization, ensuring that all pharmaceutical products meet internal and regulatory quality standards. This role provides strategic oversight of Quality Assurance (QA), Quality Control (QC), and compliance with federal regulations for current Good Manufacturing Practice (cGMP) for finished pharmaceuticals and Active Pharmaceutical Ingredients (API) across manufacturing. The Executive Director plays a key leadership role in driving a culture of quality, continuous improvement, and operational excellence.

Job Responsibilities:

• Directing the day-to-day responsibilities and duties of personnel including:
  1. Manufacturing/Quality Assurance Liaisons (MQAs)
  2. Scientific/Quality Assurance Liaisons (SQAs)
  3. QA Compliance Associate
• Performing manufacturing investigations, writing investigation reports, and facilitating corrective and preventive actions including:
  1. Incident Reports
  2. Process Deviation Reports
  3. Customer Complaints
  4. Internal Audit Responses
  5. Internal Process Observation Responses
• Providing management oversight for Development Batches and for API Synthesis including:
  1. MBR generation and/or revision
  2. Maintains the Master Batch Record Revision Table
  3. Lot Number assignment
  4. BPR issuance
  5. Communication liaisons to plan, prepare, and execute development products and PPQ batches
  6. Review of Batch Production Records post execution
  7. Prepare documentation for API product disposition
  8. Trending of Quality metrics
• Providing management oversight for all cGMP equipment
• Providing support for manufacturing of commercial products
• Providing support for the Internal Audit Program
• Performs other duties as assigned

Required Skills:

• Strong leadership, team-building, and decision-making skills.
• Excellent communication and presentation skills.
• Ability to manage competing priorities in a dynamic, fast-paced environment.
• Hands-on approach with a strategic mindset.
• 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 and Experience Requirements:

Education

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field (required).
• Advanced degree (MS, PhD, or MBA) preferred.

Experience

• Minimum 10 years of progressive experience in pharmaceutical quality, with at least 5 years in a senior leadership role.
• Experience in a small or mid-sized pharmaceutical or biotech company is strongly preferred.
• Extensive knowledge of cGMP regulations, FDA/EMA requirements, and international regulatory expectations.
• Proven experience managing CMOs and third-party vendors preferred.