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 about 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 (i.e., Biochemistry, Biology, Molecular Biology).
• 8+ years 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, adopting messaging to fit the education level of the audience.
• Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook).