Base: $120k-$150k doe; bonus/equity: not specified...
Remote
Iso/iec 17025:2017 accreditation maintenance
21 cfr part 11, 210, and 211 compliance
Gmp environment experience in pharmaceuticals
Element is seeking a Quality Manager for its Concord, CA location, focused on ensuring compliance with quality management systems and regulatory standards in the pharmaceutical/biotechnology industry. The ideal candidate will have significant experience in quality assurance and leadership, with a strong emphasis on maintaining ISO accreditation and regulatory compliance
Job Summary
The Quality Manager ensures services meet customer expectations while adhering to strict regulatory requirements like ISO/IEC 17025:2017 and GMP standards.
This role involves leading the Validation and Calibration Services department, managing quality events such as deviations and CAPAs, and overseeing the MasterControl eQMS system.
Element is a rapidly growing global testing organization that empowers employees to take charge of their careers while maintaining high standards of accuracy and integrity.
Matching Summary
Match Score: 85
Element is seeking a Quality Manager for its Concord, CA location, focused on ensuring compliance with quality management systems and regulatory standards in the pharmaceutical/biotechnology industry. The ideal candidate will have significant experience in quality assurance and leadership, with a strong emphasis on maintaining ISO accreditation and regulatory compliance.
Salary
Base: $120k-$150k DOE; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
ISO/IEC 17025:2017 accreditation maintenance
21 CFR Part 11, 210, and 211 compliance
GMP environment experience in pharmaceuticals
MasterControl eQMS system oversight
Validation and Calibration Services leadership
Deviation and CAPA investigation expertise
Nice-to-have
Strong interpersonal and communication skills
Proactive self-motivated individual
Experience with USP, FDA, and ICH guidelines
Team leadership and coaching abilities
Customer service orientation
Key Requirements
BS Degree in life sciences or related field
8 years pharmaceutical/biotechnology industry experience