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 requirementsEstablish and maintain strong relationships with clients and accreditation bodies.Remain knowledgeable on the quality and regulatory landscape and communicate to the rest of the siteProvide leadership and representation of Element to third party organizations, clients, accreditation bodies/committees, suppliers/vendorsCreate post-audit/inspection responses and ensure all components are completed in a timely mannerInteracting with clients and regulatory authorities regarding cGMP and IND, NDA and DMF filingSupport 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 necessaryMaintain 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 aspectsMaintaining a satisfactory Quality SystemOverseeing final disposition of Intermediates and Active Pharmaceutical Ingredients (APIs)Supervising the Quality Unit personnelManaging the development, review and approval of Standard Operating Procedures and all other cGMP documentationOverseeing Approval of Master Production RecordsEnsure proper Review and approval of validation, qualification, stability protocols and reportsAssistance in the development of specificationsEnsuring that quality-related investigations are properly conducted and resolvedEnsuring that internal audit requirements are metApproval of contract laboratories and vendorsMaintaining Controlled Substance ProgramHelp create and maintain a positive work environmentOther duties as assigned. Skills / Qualifications BS in Lifesciences (ie., Biochemistry, Biology, Molecular Biology)8+ years Quality experience in cGMP and/or ISO IEC 17025Broad knowledge of GMP regulationsKnowledge of CFR parts 11, 210, and 211Success in writing project plans and driving them to conclusionProficiency in standard office software and computer systemsStrong interpersonal and communication skillsExcellent organizational skills, ability to manage multiple projects under changing prioritiesTeam-oriented leader and coachStrong 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)#LI-TK1
Company OverviewElement 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 make certain 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 support 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.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.
Diversity StatementAt 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)
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