Quality Assurance Manager

Job Description

Job DescriptionDescription:

About the role

The Quality Assurance Manager will play a pivotal role in managing the development, implementation and sustainment of the Quality Processes and Systems relating to Global QA and Cell and Gene Therapy (C&G) products.

Job Duties:

• 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 CAPA’s, 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.