Manager, QA Compliance

Job Responsibilities

• Implements and Manages the Change Control Quality System for all GMP activities and works with responsible cross functional areas ensure timely completion.
• Runs the Change Control Review Boards, generate meeting minutes, follow up on action items and facilitate resolution when required.
• Communicates effectively with cross functional stakeholders on matters related to change control process.
• Implements and manages the necessary investigations and CAPA review boards at a timely manner.
• Responsible for the site Quality Council program and acts as Quality Council Lead.
• Develops and Maintains Quality Metrics to monitor compliance.
• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues.
• Leads site Data Integrity Program.
• Responsible for complaints.
• Participates as a core team member in any corporate or health authority inspections.
• Identifies and reports discrepancies from required work practices or procedures to management.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Ledds teams and cross-functional project teams and drives team performance and results.
• Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams.
• Applies AI to improve team execution and decision-making.

Education And Experience

• A bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.
• Minimum 5 years of work experience in Quality Assurance.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.