Quality Manager

Element Materials Technology•Concord, CA

37d•Onsite

About The Position

Element has a current opening for a Quality Manager to join our growing team in Concord, CA. The Quality Manager aims to ensure that services provided fit its purpose and meets customer expectations at Element Concord. The Manager’s main duties are to ensure compliance and accuracy when reporting results to clients. The Manager must provide services that adhere to the quality management system, client requirements, and regulatory requirements as applicable i.e. ISO/IEC 17025:2017, USP, GMP, FDA, and ICH guidelines. The Quality Manager monitors and advises on how the quality management system is performing and publishes data and reports regarding company performance against set indicators. The Quality Manager liaise with staff throughout the organization to ensure that the quality systems are functioning properly. The Quality Manager advises on changes and their implementation and provides training, tools, and techniques to enable others to achieve and maintain quality.

Requirements

A BS Degree in life sciences or related field of study.
8 years of pharmaceutical/biotechnology industry experience in a GMP environment.
2 years of supervisory experience.
Advance knowledge and hands-on experience in QA and cGMP.
Self-motivated, proactive individual with strong interpersonal skills, excellent oral and written and communication skills, strong computer skills and customer service.
Ability to work as a team member.
Effective people leader.
Nurture employee potential through coaching, mentoring, and training.
Provide guidance, set clear goals, provide regular feedback, and conduct performance reviews.

Responsibilities

Provides quality leadership and oversight, ensuring compliance to 21 CFR Part 11, 210, and 211 requirements.
Maintain ISO 17025 accreditation.
Leads and provides oversight to the Validation and Calibration Services (VCS) department, ensuring applicable regulatory standards are adhered to.
Prepares company quality systems review and ensures that the Quality System is continuously improving.
Ensures compliance with national and international standards as applicable.
Oversee training and adherence to MasterControl eQMS system.
Ensure procedures are written appropriately, testing is performed per procedure, and quality events (deviations, non-conformances, OOS’, CAPAs etc.) are investigated appropriately and resolved.
Write technical and management system reports; bringing together staff of different disciplines and driving the group to plan, formulate and agree comprehensive quality procedures.
Review and approval of validation and qualification protocols and reports.
Handles clients and regulatory agencies issues such as audits, execution of corrective action, and compliance with customers' specifications.
Manages quality assurance and VCS personnel ensuring they have adequate background, training, and competency to perform duties to which they are assigned.