Job Details

Overview

Element is currently hiring for a Quality Manager to join our growing team in Santa Rosa, CA. The Quality Manager provides direct oversight of Quality personnel at the Santa Rosa location. This position ensures the site Quality Management System is compliant with applicable regulations as well as Element Business Unit policies and procedures.

Responsibilities

• Develop and ensure compliance with applicable regulatory requirements
• Establish and maintain strong relationships with clients and accreditation bodies.
• Remain knowledgeable on the quality and regulatory landscape and communicate to the rest of the site
• Provide leadership and representation of Element to third party organizations, clients, accreditation bodies/committees, suppliers/vendors
• Create post-audit/inspection responses and ensure all components are completed in a timely manner
• Interact with clients and regulatory authorities regarding cGMP and IND, NDA and DMF filing
• Support the Quality and regulatory training and development of colleagues (including cGMP training including FDA and ICH guidelines)
• Participate and advise on adjustments to quality procedures and processes, as necessary
• Maintain a high level of ethics in day-to-day operations and decisions.
• Provide guidance and expert advice on technical, systems, quality, risk management, or process-related business improvement aspects
• Maintain a satisfactory Quality System
• Oversee final disposition of Intermediates and Active Pharmaceutical Ingredients (APIs)
• Supervise the Quality Unit personnel
• Manage the development, review, and approval of Standard Operating Procedures and all other cGMP documentation
• Oversee Approval of Master Production Records
• Ensure proper review and approval of validation, qualification, stability protocols and reports
• Assist in the development of specifications
• Ensure that quality-related investigations are properly conducted and resolved
• Ensure that internal audit requirements are met
• Approve contract laboratories and vendors
• Maintain Controlled Substance Program
• Help create and maintain a positive work environment
• Other duties as assigned.

Skills / Qualifications

• BS in Lifesciences (e.g., Biochemistry, Biology, Molecular Biology)
• 8+ years of Quality experience in cGMP and/or ISO IEC 17025
• Broad knowledge of GMP regulations
• Knowledge of CFR parts 11, 210, and 211
• Success in writing project plans and driving them to conclusion
• Proficiency in standard office software and computer systems
• Strong interpersonal and communication skills
• Excellent organizational skills, ability to manage multiple projects under changing priorities
• Team-oriented leader and coach
• Strong public speaking skills with the ability to deliver complex messages to all audiences, adapting messaging to fit the education level of the audience.
• Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook)

Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally, we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today'.

When failure in use is not an option, we help customers ensure that their products, materials, processes, and services are safe, compliant, and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists supports customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career and reward excellence and integrity with growth and development.

Diversity Statement

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our vision of becoming “the world's most trusted testing partner”.

All suitably qualified candidates will receive consideration for employment on the basis of objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.

If you need an accommodation filling out an application, or applying to a job, please email ...@element.com