Quality Manager

Overview

Element has a current opening for a Quality Manager to join their team in Concord, CA. The Quality Manager ensures services meet purpose and customer expectations at Element Concord. Key responsibilities include compliance and accuracy reporting, maintaining ISO 17025 accreditation, leading validation and calibration services, and managing quality assurance and VCS personnel.

Responsibilities

• Provides quality leadership and oversight, ensuring compliance to 21 CFR Part 11, 210, and 211 requirements.
• Maintains ISO 17025 accreditation.
• Led the Validation and Calibration Services (VCS) department, ensuring regulatory standards are adhered to.
• Prepares company quality systems review and ensures continuous improvement of the Quality System.
• Ensures compliance with national and international standards as applicable.
• Oversees training and adherence to MasterControl eQMS system.
• Ensures procedures are written appropriately, tests are performed per procedure, and quality events are investigated appropriately and resolved.
• Writes technical and management system reports, involving staff from different disciplines.
• Reviews and approves validation and qualification protocols and reports.
• Handles clients and regulatory agency issues such as audits, corrective actions, and compliance with customers' specifications.

Qualifications

• A BS degree in life sciences or related field of study.
• At least 8 years of pharmaceutical/biotechnology industry experience in a GMP environment.
• At least 2 years of supervisory experience.
• Advanced knowledge and hands-on experience in QA and cGMP.
• Self-motivated, proactive individual with strong interpersonal skills, excellent oral and written communication, strong computer skills, and customer service.
• Effective people leader, able to coach, mentor, and train employees, set clear goals, provide regular feedback, and conduct performance reviews.

Skills

• Strong leadership and oversight skills.
• Compliance with regulatory standards (e.g., ISO/IEC 17025:2017, USP, GMP, FDA, ICH guidelines).
• Quality system management and improvement.
• Training and competency management.
• Technical and management system report writing.
• Validation and qualification protocol and report handling.
• Client and regulatory agency issue resolution.