Senior Director of Quality

Senior Director of Quality

The Head of Quality oversees the combined effort of the Quality Assurance and Quality Control departments. Required attributes include an innovative, results-driven, and broad-minded quality control and assurance executive with extensive experience in compliance and regulations, systems management, deviations, design and development, project management, strategic planning, training, and mentoring, client/vendor relations, performance management, and change management. Extensive experience with laboratory operations is required.

The successful candidate will have excellent problem-solving skills and will identify critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments.

Responsibilities:

• Building and leading the Quality Assurance and Quality Control groups
• Provides constructive and timely performance evaluations
• Handles discipline and termination of employee in accordance with company policy
• Performs other related duties as assigned.
• Implementation and continuous improvement of the company’s quality systems and facility validation
• Quality Systems, Deviations, CAPA, EV, Change Control, Document Management, validation, and auditing
• Document authorship, review, and approval of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
• Oversight of investigations
• Support of internal audits, client audits and regulatory inspections, as needed
• Oversight of a broad range of documentation including, but not limited to User Requirements (URS), Functional and Design Specifications, Testing Protocols (Cx/IQ/OQ/PQ), Change Control, and Risk Assessments
• Work with cross-functional teams to troubleshoot equipment, process, and validation issues

Requirements:

• Broad knowledge FDA and international regulations related to GMP and Pharmaceuticals
• Experience organizing and managing work responsibilities while working independently with minimal oversight
• Time and project management skills with the ability to multi-task and meet deadlines
• Excellent verbal and written communication skills
• Excellent interpersonal and customer service skills
• Excellent organizational skills and attention to detail
• Strong analytical and problem-solving skills
• Strong supervisory and leadership skills
• Ability to prioritize tasks and to delegate them when appropriate
• Proficient with Microsoft Office Suite or related software

Education and Experience:

• Minimum of a bachelor’s degree, preferably in a scientific discipline. An advanced degree is preferred
• 15+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
• Experience with facility validation activities
• Experience with regulatory inspections by the FDA and EU authorities