Quality Manager

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 to 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
• Interacting 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 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
• Maintaining a satisfactory Quality System
• Overseeing final disposition of Intermediates and Active Pharmaceutical Ingredients (APIs)
• Supervising the Quality Unit personnel
• Managing the development, review and approval of Standard Operating Procedures and all other cGMP documentation
• Overseeing Approval of Master Production Records
• Ensure proper Review and approval of validation, qualification, stability protocols and reports
• Assistance in the development of specifications
• Ensuring that quality-related investigations are properly conducted and resolved
• Ensuring that internal audit requirements are met
• Approval of contract laboratories and vendors
• Maintaining Controlled Substance Program
• Help create and maintain a positive work environment
• Other duties as assigned.

Skills / Qualifications

• BS in Lifesciences (ie., 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)

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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 or other characteristics in accordance with the applicable governing laws.

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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