Director Of Quality Assurance

Description:

The Director of Quality Assurance is tasked with defining and promoting a quality mindset across an entire site. S/he is responsible for managing all QA functions, working with cross-departmental leadership to deliver high quality products on schedule. From hiring QA specialists and managers to leading deviation investigations, the QA director establish and maintain a quality system to ensure the company’s facilities, utilities, equipment, personnel, methods, processes, and procedures conform to both internal standards and regulatory requirements.

1. Responsibilities

1.1 Oversee the GMP compliance and product quality of overall GMP operations for the site and provide the suggestions and recommendation to upper management to ensure GMP compliance and the quality of products.

1.2 Establish and maintain a quality management system that meets the global regulatory requirements and ensures product quality. Host global regulatory inspections to ensure successful regulatory inspections.

1.3 Oversee the product release function and ensure the manufacturing and testing of products are in accordance with quality compliance requirements, regulatory approved manufacturing processes, and quality standards/specifications before the release of the products.

1.4 Approve product specifications, manufacturing master batch records, sampling methods, and testing methods, and other quality operation SOPs.

1.5 Review and approval of quality management system (QMS) activities such as change control, deviations, OOS, and OOT to ensure that QMS activities are handled according to regulatory requirements.

1.6 Ensure that that the facilities, utilities, and equipment are maintained in a validated or qualified state.

1.7 Ensure the validation programs and SOPs are properly established and they meet regulatory requirements.

1.8 Approve the qualifications and validation master plans, validation/qualification reports and ensure the execution of all qualifications/validations in a timely manner.

1.9 Review and approve the suppliers of in-coming materials, contract testing laboratories, contract manufacturing organizations, and other service provides. Sign quality agreements with suppliers and contract service providers.

1.10 Establish and maintain the internal audit program (SOP); review and approve the internal audit plans, report, and CAPA plans, and ensure the internal audits and CAPA are executed according to the audit plans or CAPA plans.

1.11 Establish and maintain the complaint program (SOP); review and approve the complaint reports to ensure all quality complaints are thoroughly investigated and ensure the CAPA plans for the resolution of the complaints are developed and executed.

1.12 Review and approve annual product quality review reports to ensure that product quality reviews are performed in a timely manner and meet the regulatory and CARsgen’s requirements.

1.13 Review and approve the site training plan and ensure the timely execution of the training plan and ensure that the staff are properly trained before performing the job.

1.14 Maintain professional and technical knowledge by reviewing regulatory guidance and professional publications, establishing personal networks, and participating in professional societies.

1.15 Achieve financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions.

2. Qualification

2.1 Master’s Degree or above in life sciences or a related field with a minimum of 10 years’ work experience in GMP manufacturing or Bachelor’s Degree in life sciences or related with a minimum of 15 years’ work experience in GMP manufacturing

2.2 At least 3 years management experience in a biotech industry

2.3 Experience in hosting FDA, EMA, and other regulatory agencies’ inspections

2.4 Experience in establishing and improving quality systems.

2.5 Excellent written and oral communication skills

2.6 Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.

2.7 Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.

2.8 Goal oriented with the ability to troubleshoot and resolve problems.

2.9 Strong interpersonal skills, with experience in leading high-performance team and cross functional projects.

2.10 Team building and managing skills including recruiting, coaching, counseling, and disciplining.