Quality Manager
Quality Manager
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Salary Not Disclosed
1 Vacancy
Job Description
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 postaudit/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 processrelated 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 qualityrelated 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
- Teamoriented 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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Company Overview
Element is one of the fastest growing testing inspection and certification businesses in the world. Globally we have more than 9000 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 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 worlds 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 contractors legal duty to furnish information. 41 CFR 601.35(c)
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Required Experience:
Manager
Employment Type
Unclear
