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Job DescriptionJob DescriptionDescription:
The Quality Manager will play a pivotal role in managing the development, implementation, and sustainment of the Quality Processes and Systems relating to Global Quality Assurance and Cell and Gene Therapy (C&G) products.
Main Duties and Responsibilities:
Provide strategies to address compliance gaps or determine enhancements to cross-functional quality system.
Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role.
Be the Mentor, the Global QA-SME, and the single point of contact for the headquarters, all branches, depots, extensions, third party service providers and suppliers, as needed.
Design and train organization for C&G to comply with various regulatory and client requirements. Train the trainers across the company.
Effectively collaborate as part of a multidisciplinary team to develop novel processes for C&G logistic services.
Provide support to Quality Department projects such as in the Commissioning and Qualification activities for the new cGMP facility builds.
Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.
Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends.
Establish and maintain the internal/external audit program, host/represent in client audits, review and approve the audit plans, report, and CAPAs, and ensure that the CAPAs are executed according to the plans.
Implement and monitor the routine systems, procedures, and records to support cGMP, GCP, GDP and disposition of G&G shipments/products.
Contributes towards the development of the Quality System infrastructure for C&G.
Perform records review in a cGMP manufacturing environment with a focus on novel challenges of C&G, as needed.
Support review of documents such as records, methods and validation protocols/reports.
Participate in quality investigations, assessments, and evaluations of quality records such as deviations, CAPAs, and change controls.
Provide hands-on QA support and oversight to internal staff to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.
Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.
Requirements:
Bachelor of Science degree, preferably in a Biological Science related field.
Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required.
Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams.
Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products.
Strong knowledge of current industry trends and the ability to use the latest technologies.
Successful in mentoring people managers.
Minimum of 3 years experience in a cGMP/GCP/GDP role supporting Cell Therapy Products.
Production knowledge of biotech products for clinical use in humans is required.
Direct experience with quality investigations, assessments, reviews and/or evaluations of quality events such as CAPAs, deviations, change control, etc.
Excellent communication and interpersonal skills with the ability to influence to positive resolutions.
Strong decision making and problem-solving abilities with the ability to identify creative solutions.
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