Deviations & CAPA Mastery: Leverage your 10+ years of experience handling deviations and corrective action/preventive action (CAPA) processes to lead investigations, identify root causes, implement effective remediations, and ensure long-term corrective actions prevents recurrence.
Championing Data Integrity: Advocate for and uphold the highest standards of data integrity across the organization, analyze trends, evaluate potential data risks, and collaborate with stakeholders to develop and implement robust data integrity strategies.
Leadership & Collaboration: Lead a team of QA professionals, fostering a collaborative and growth-oriented environment. Mentor and coach team members, delegate tasks effectively, and ensure efficient execution of quality initiatives.
Strategic Vision & Communication: Partner with cross-functional teams to strategize on large scale QA initiatives. Translate complex technical data into actionable insights for leadership and stakeholders, facilitating impactful decision-making through clear and concise communication.
Process Optimization: Continuously assess and optimize internal QA processes, implementing best practices and innovative solutions to drive efficiency and improve quality at every stage.
Regulatory Compliance: Ensure adherence to all relevant regulatory requirements and industry standards relevant to the organization's operations.
Qualifications:
Minimum 10 years of experience in quality assurance, with a strong focus on deviations and CAPA management.
Must have recent experience within the Life Sciences/Healthcare industry.
Proven track record of successfully leading and resolving complex deviation and CAPA cases.
In-depth understanding of data integrity principles and best practices.
Strong analytical and problem-solving skills, with the ability to identify root causes and implement effective solutions.
Excellent communication, collaboration, and leadership skills.
Experience working in a fast-paced, dynamic environment.
Experience in implementing quality management systems (e.g., ISO 13485, FDA QSR)
Knowledge of specific industry regulations relevant to the organization.
Experience with statistical analysis and data visualization tools.
Bachelor's degree in a relevant field (e.g., science, engineering, healthcare) preferred.