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Job Title: Senior Manager Clinical Quality Assurance Location: Greater Philadelphia Area Type: Full Time, Salaried with benefitsStart: ImmediateSpecialty Pharmaceutical Company hiring a Senior Manager of Clinical Quality Assurance to join their team! Responsibilities: Responsible for the development and management of all clinical quality activities
Development and implement the Quality Management System (drug and device)
Manage and conduct all quality audits, support vendor selection and auditing process
Oversees the QA/QC process for and participates in the preparation of all submissions to regulatory authorities. This includes pre-IND materials, clinical development documents, NDA submissions and post approval submissions
Develop, implement and maintain the training process for the organization.
Support the global QA processes including product release and distribution as necessary.
Create and maintain internal SOPs and support internal policy / procedure reviews.
Identifies project needs and creates required quality plans, budgets & timelines
Requirements:Bachelor’s degree required.
4-8 years of drug/biologic quality or Regulatory affairs experience
Significant prior experience hosting regulatory authority inspections; GCP audits
Prior experience creating and maintaining internal SOPs and support internal policy / procedure reviews as well as quality operations.
Knowledge of US, EU and ICH regulatory requirements for the conduct of clinical trials and submission of dossiers supporting approval (CMC, labeling changes, non-clinical and clinical data supplements).
Experience with quality aspects of eCTD submissions and publishing requirements and the electronic filing of INDs, CTAs for clinical studies and NDA’s.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
