Head of GxP Audit & Compliance 100% (m/f/d)

Acino

  • United Arab Emirates
  • Permanent
  • Full-time
  • 3 days ago
Location: flexible (Egypt, Turkey, Dubai, Estonia, Kyiv, Germany), excluding SwitzerlandArcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.The Head of GxP Audit & Compliance will be responsible for overseeing the audit and compliance functions within the pharmaceutical operations of ArCera Health Life Sciences. This role will ensure that all company operations adhere to stringent regulatory requirements, internal policies, and industry standards, specifically focusing on compliance with GxP requirements.The Head of GxP Audit & Compliance will lead a team and network of compliance professionals and work closely with other departments to drive continuous improvement in compliance systems and processes. This includes conducting thorough internal and external audits to identify areas for improvement, preparing for inspection from regulatory bodies, and implementing corrective/preventive actions as needed. Establishing effective inspection readiness strategies will be critical, including audit simulations, readiness assessments, and continuous monitoring to maintain a state of perpetual compliance.In addition, the Head of GxP Audit and Compliance will build a comprehensive risk profile for each product, system, and Contract Manufacturing Organization (CMO) associated with ArCera Health Life Sciences. This involves identifying potential risks, evaluating their impact, and developing mitigation strategies to address these risks. Regular risk assessments and updates to the risk profiles will ensure that all potential compliance issues are proactively managed. Collaborative efforts with cross-functional teams will be essential to accurately assess and manage these risks, ensuring that ArCera's products and operations remain compliant with regulatory standards.Furthermore, this role will develop and implement strategic initiatives to enhance regulatory intelligence, anticipate industry trends, and engage externally with regulatory bodies and industry stakeholders. This will involve staying ahead of regulatory changes, building strong relationships with the e.g. FDA, EMA, Swissmedic and other regulatory authorities, and positioning ArCera as a leader in compliance management within the pharmaceutical sector.Key Responsibilities1. Strategic Leadership:
  • 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.
2. Operational Excellence and Continuous Improvement:
  • 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.
3. Crisis and Risk Leadership:
  • 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.
4. Talent & Team Development:
  • 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.
5. Governance and Compliance:
  • 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.
6. Organizational Savviness:
  • 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.
7. End-to-End Global Network Transformation & Optimization:
  • 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.
Key Competencies
  • 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.
Qualifications & Experience
  • 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.

Acino