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
