Senior Director of Quality

Senior Director of Quality at Germer International - Pharmaceutical Recruiting Senior Director of Quality at Germer International - Pharmaceutical Recruiting in Gloucester City, New Jersey Posted in 10 days ago.

Type:

full-time

Job Description:

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