Head of GxP Audit & Compliance 100% (m/f/d)
- الإمارات
- دائم
- دوام كامل
- Develop and implement audit and compliance strategies and policies for all ArCera regions, ensuring consistency, regulatory adherence, and operational excellence.
- Collaborate with cross-functional leaders (e.g., Manufacturing, Commercial, Regulatory Affairs, Supply Chain) to ensure compliance strategies align with business needs and regulatory requirements throughout the product lifecycle.
- Anticipate future trends in healthcare regulations, technology, and customer expectations to position compliance as a pivotal element in the company's competitive advantage, fostering innovation and trust in products and processes.
- Oversee compliance processes and ensure the integrity of all audit activities.
- Drive continuous improvement initiatives to enhance compliance efficiency and effectiveness.
- Utilize trend analysis and data analytics within the compliance systems to drive decision-making and continuous improvement.
- Leverage digital tools to enhance compliance reporting and monitoring capabilities.
- Ensure global and local compliance operations are harmonized, agile, and responsive to market needs while remaining inspection-ready.
- Identify and mitigate potential risks related to regulatory compliance.
- Implement proactive measures to ensure adherence and prevent compliance issues before they arise.
- Manage and resolve escalations related to compliance, ensuring timely and effective resolution.
- Confirm adherence to SOPs, Quality Directives, and other related documentation during all stages of product development and manufacturing.
- Lead and develop a high-performing team, fostering collaboration across functions and regions. Focus on upgrading capabilities and building a future-ready organization.
- Develop talents and foster a growth-mindset, promoting a culture of business acumen and continuous learning.
- Establish Quality & Data integrity culture and awareness, ensuring that all team members understand and prioritize these principles.
- Role Model Arcera Values.
- Change Leadership, Lead yourself, Lead business, Lead others.
- Ensure adherence to all relevant regulatory requirements and industry standards.
- Represent the company in regulatory inspections, audits, and Pharma associations.
- Establish and monitor Key Compliance Indicators (KCI) to track performance and identify trends.
- Collaborate with other departments to identify and address compliance issues.
- Oversee compliance assurance activities related to the entire product lifecycle management, ensuring each phase meets the highest standards.
- Monitor and report on key compliance metrics and performance indicators.
- Drive initiatives to optimize the global compliance network and enhance operational efficiency.
- Enable scalable, future-ready processes, leveraging automation, data analytics, and cross-functional workflows to optimize compliance impact.
- Navigate and influence a complex matrix organization, balancing global standardization with local flexibility.
- Strategic thinking and planning;
- Leadership and team management;
- Regulatory compliance and audit assurance;
- Continuous improvement and process optimization;
- Effective communication and collaboration;
- Analytical and problem-solving;
- Risk management and preventive compliance;
- Data analytics and trend analysis;
- Digital savvy and digital tools proficiency;
- Strong business acumen.
- Bachelor's degree in a related field; advanced degree preferred;
- Minimum of 10 years of experience in compliance or a related field;
- Proven experience in a senior leadership role overseeing networks in multiple sites and commercial regions, with understanding of local and global regulations;
- Strong analytical and problem-solving abilities;
- In-depth knowledge of regulatory requirements and industry standards;
- Strong leadership and team management skills;
- Excellent communication and interpersonal skills;
- Ability to work collaboratively with cross-functional teams.