Associate Director Quality Control, null

Social network you want to login/join with: Associate Director Quality Control Client: WuXi AppTec Location: Job Category: Other Job Reference: decfaafc718b Job Views: 4 Posted: 03.03.2025 Expiry Date: 17.04.2025 Job Description: Overview This position is a key leadership role responsible for the direct management of individual contributors, supervisors, and managers. This position serves as a role model for the WuXi values and competencies. Job Summary: The Associate Director Quality Control is charged with overseeing the Quality Control department, providing leadership to the respective teams and ensuring that the highest standards of health and safety are adhered to. The role is accountable for all analytical and microbiological incoming, release & stability testing, as well as the transfer, verification, and validation of new methods related to New Product Introductions. Additionally, this role ensures timely and cost-effective quality control through effective resource utilization in accordance with all Good Manufacturing Practices (GMP), while considering the company\’s commitment to Core Values and Behaviors. Responsibilities Department Management Guide, mentor & develop teams to achieve an environment of personal accountability and trust. Align with the site to set strategy & priorities for teams, ensuring focus on the right initiatives. Manage teams by setting & tracking goals and tasks, continuously improving processes. Ensure proactive priority and daily activity management for teams and activities. Define and document department processes; implement & monitor KPIs. Communicate proactively and collaboratively with peers, stakeholders, and partners. Use risk management & scientific assessments for resource allocation. Stay updated with current industry best practices for operational and strategic advantage. Accountable for the department budget (OPEX and CAPEX). Quality Control Ensure timely delivery of all QC activities to meet client expectations. Manage raw material, release & stability testing, and method validation. Delegate activities within the site and ensure compliance in execution. Investigate and resolve out of specification results and deviations. Identify and present business cases for continuous improvement. Coordinate process optimizations within QC and across the site. New Product Introduction Build and maintain relationships with clients regarding Quality Control. Ensure client well-being during site visits, including organizing activities and documentation. Propose solutions to client requests, especially in case of conflicts with other departments. Escalate client concerns to the project manager and site head. Compliance Plan, execute, and track all compliance activities (GxP and other regulatory requirements). Manage documentation and ensure alignment with corporate policies. Define training curriculum and ensure timely completion. Coordinate CAPAs, deviations, and Change Controls. Lead complex investigations and resolution of quality complaints. EHS Line Managers shall provide a safe and healthy work environment for staff and ensure compliance with relevant rules and legislation. Identify members of the department for the site EHS team. Work with EHS to evaluate hazards and perform risk analysis. Train staff on hazards and promote safe practices. Qualifications Experience / Education 15+ years experience in a pharmaceutical company or other GMP industry, ideally in solid dosage forms. 10+ years people management experience, preferably in Quality Control. University Degree in a scientific field or equivalent. Knowledge / Skills / Abilities Exceptional management skills to maintain accountability and trust. Decisive leader capable of making important decisions under pressure. Organized and rigorous with strong change management skills. Strong knowledge of GMP, FDA, Eudralex, PICS, and GAMP regulatory requirements. Excellent communication skills within teams and across the organization. Proven track record of meeting targets while upholding health and safety standards. Exceptional problem-solving ability; experience with lean/Six Sigma is advantageous. Experienced in presenting during regulatory audits (FDA and SwissMedic). #J-18808-Ljbffr