Head of Technical Quality Operations 100%(m/f/d)

• Develop and implement quality strategies that align with the organization's long-term goals and regulatory standards.
• Act as a quality business partner to cluster manufacturing team, balancing compliance with business needs.
• Demonstrate a strong strategic mindset by proactively identifying opportunities for improvement and innovation within quality operations.
• Anticipate future challenges and set long-term goals to ensure continuous improvement and maintain a competitive edge in the industry.
• Foster a culture of critical and strategic thinking within the team to drive the organization towards excellence in quality assurance and regulatory compliance.
• Emphasize the importance of innovation and digital as a key driver for progress and competitive advantage, ensuring the organization remains at the forefront of the industry.

• Oversee the uniform implementation of Corporate Directives and Global Standard Operating Procedures across the manufacturing operations network to ensure a unified quality standard across the network.
• Own and oversee the release of commercial products to the market, ensuring all quality requirements are met.
• Advocate continuous improvement, spearheading efficiency programs to streamline processes, foster synergy, and add value to the organization. . Utilize methodologies such as Lean, Six Sigma, and Kaizen to drive end-to-end improvements.
• Develop and maintain a robust Quality governance framework and process management strategy across the network to ensure operational excellence and key quality performance indicators are met.
• Implement a site readiness program to ensure preparedness for any upcoming audits or inspections.
• Prioritize and lead innovative ideas in collaboration with the network to advance predictive analytics and performance. Examples include advanced data analytics, automated quality control, and blockchain for traceability and proactiveness.Ensure a unified quality voice and culture within Arcera by implementing key milestones needed to progress to the next level. Foster a culture of collaboration and continuous improvement across all teams.

• Employ analytics to monitor compliance trends and address any emerging risks proactively.
• Oversee product complaints and investigations, ensuring timely resolution and effective root cause analysis.
• Collaborate closely with commercial, medical, and pharmacovigilance teams to ensure prompt resolution of quality-related issues impacting patients and customers.
• Lead quality interactions with distributors, third-party logistics providers (3PLs), and contract manufacturers to ensure compliance.

• 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

• Develop and maintain a robust Quality governance framework and process management strategy across the network to ensure operational excellence and key quality performance indicators. Establish a robust Quality Plan to guide operations and maintain consistency.
• Lead compliance with global regulatory requirements (e.g. FDA, EMA, MHRA, WHO, etc.) and ensure adherence to GMP, GDP, and quality standards. Conduct Quarterly Quality Review Boards to assess compliance and identify areas for improvement.
• Oversee quality risk management, identifying and mitigating risks related to product quality, supply chain, and distribution. . Implement preventive actions through analytics and trending to address potential risks proactively.
• Partner with regulatory affairs to maintain product licenses, handle regulatory inspections, and address market compliance issues.
• Contribute to Monthly Business Reviews (MBRs) and by providing insights on compliance and governance.
• Implement External Engagement initiatives to collaborate with industry partners, regulatory bodies, and other stakeholders.
• Ensure management training on awareness of quality, compliance requirements and systems.
• Ensure appropriate disciplinary actions are taken in case of willful or negligent GMP violations.
• Employ analytics to monitor compliance trends and address any emerging risks proactively.

• Strategic Thinking: Ability to set a long-term strategic vision while executing immediate priorities, leveraging digital technologies, IoT, and AI to drive innovation and efficiency.
• Change Management: Proficiency in leading organizational change and foster a culture centred on quality and compliance, and ensuring employee engagement. Utilize digital tools and AI-driven insights to manage change effectively.
• Decision-making under pressure: make high impact decisions in complex and ambiguous situations.
• Business Acumen: Understanding of the pharmaceutical industry landscape, regulatory requirements, that drive sustainable growth and competitive advantage.
• People leadership: Developing leadership pipelines and fostering a strong organizational culture.
• Organizational savviness: Expert at navigating complex corporate structures, building strong cross-functional relationships and influencing key stakeholders to align quality strategies with business objectives.
• End-to-End Global Network Transformation & Optimization: Proven expertise in designing and leading the transformation of fully integrated global networks, encompassing manufacturing, quality, supply chain, digital, and B2B operations. Adept at driving network optimization through data-driven decision-making, advanced digital technologies, and strategic partnerships. Skilled in fostering a transformation mindset, enhancing agility, and aligning regional and global operations to improve efficiency, resilience, and business performance.

• Experience in international GMP requirements.
• Exhibit a strong blend of strategic and operational skills, with the ability to make flexible yet thorough decisions in a highly dynamic environment.
• Proficient in managing across QC and QA organizations, implementing proper controls to mitigate unforeseen events.
• Proven leadership experience in global quality management within the pharmaceutical industry.
• Strong understanding of regulatory requirements and quality standards.
• Excellent strategic planning and organizational skills.
• Ability to drive change and foster a culture of quality and compliance.
• Experience with quality by design and operational excellence initiatives.

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