Manager, QA (IC role)

As the Audit and Inspection Program Manager, your primary responsibility will be to manage and ensure the proper execution of audit and inspection programs. You will oversee designated global audit programs to ensure compliance with the master audit plan, including procedures, execution, quality control, and process compliance. Your role will involve identifying the scope of audits and leading global audit teams, facilitating risk-based audits, and ensuring the consistent implementation, use, and review of Standard Operating Procedures (SOPs). You will be required to escalate issues to management in a timely manner and implement appropriate solutions, including preventative actions. Negotiating with internal stakeholders to improve quality and increase efficiencies will be a crucial part of your role. Analyzing and interpreting data to lead process improvement initiatives for Regulatory Compliance and Quality Assurance (RC and QA) processes will also be a key responsibility. In this role, you will need to effectively manage interactions with clients and regulatory agencies, interpret quality regulations and standards, and create relevant policies and procedures. Ensuring that Regulatory Compliance and Quality Assurance management responsibilities are followed as per controlled documents will be essential. Additionally, you may be required to perform other duties as needed or assigned. The minimum qualifications required for this role include a bachelor's degree in Life Sciences or equivalent experience in the Life Science field. You should have at least 10 years of experience in a regulatory environment, specifically in GXP roles, with expertise in conducting GCP and GVP audits. Experience in industry quality systems/standards, interpreting regulations and standards, leading process improvement initiatives, and effective communication and negotiation with internal stakeholders are also necessary. Preferred qualifications may include relevant and equivalent experience in place of educational requirements. The role may involve some overtime and travel, and the work environment is office-based with hybrid options as requested by the line manager. If you are looking to join a dynamic team and contribute to the enhancement of audit and inspection programs while ensuring regulatory compliance and quality assurance, this role may be perfect for you.,