For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
Reporting to the Sr. Manager, Biomanufacturing, the Manager, Compliance is responsible for overseeing the documentation lifecycle including deviations, change controls, and CAPAs for our cell and gene therapy manufacturing site. The role is responsible for leading a team of specialists supporting quality system documentation management. The ideal candidate can think critically and strategically with a complete understanding of compliance in a regulated environment.
Essential Duties And Responsibilities
- Oversee the lifecycle of quality system documents for the manufacturing site including Deviations, CAPAs, Change Controls, etc
- Provides direct superivision to a team of speciailist through daily direction, guidance, coaching, and development
- Ensure all documentation is clear, concise, and adheres to company standards and regulatory guidelines
- Completes documentation assignments within prescribed timeline independently
- Work closely with stakeholders to gather information and ensure accuracy and completeness of documentation
- Facilitate document reviews and approvals, incorporating feedback from cross-functional teams and clients
- Collaborates cross-functionally to identify the issues and communicate the scope and severity of concerns identified
- Actively manages and escalates risk and client-impacting issues to leadership, as appropriate
- Monitor and validate the status of actiones taken to remediate
- Review and investigate elevated issues, review tracking and trending, and assist with identification of process improvements to mitigate compliance risks identified data through analysis
- Stay up to date on industry standards and regulations and ensure the organization is in compliance with all requirements
- Collaborate in writing and editing technical documents including standard operating procedures (SOPs), batch records, technical reports, etc
- Analyzes and resolves problems
- Continuously improve documentation processes and templates to enhance clarity, efficiency, and compliance
- Aid in performing trainings for functional departments
- Aid in generation of reports, KPIs, metrics as needed for client program and site report outs
- Aid in inspection readiness and audit preparation activities for the site
- Measures team performance; communicates results and project priorities to senior leaders
- Maintains awareness of site goals, regulatory and compliance standards, and industry trends
- Perform other duties as assigned
Job Qualifications
- Bachelor’s degree in Life Sciences, Biotechnology, Biochemistry, or related field preferred
- Minimum of 3-5 years of technical writing experience in the biotechnology or pharmaceutical industry, preferably in cell and gene therapy
- 1-2 years of management or mentoring experience
- Exceptional writing, editing, and proofreading skills with attention to detail
- Ability to interpret and present complex scientific data in a clear and concise manner
- Proficient in Microsoft Office Suite and document management systems
- Strong organizational and project management skills
- Excellent communication and interpersonal skills
Compensation Data
The pay range for this position is $120,000 - $130,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Cognate BioServices
Cognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.
We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.
Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.
For more information, visit www.cognatebioservices.com
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
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