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

• Develop and implement quality strategies that align with business objectives, regulatory expectations and corporate quality strategy.
• Act as a quality business partner to corporate supply chain team, balancing compliance with business needs.
• Foster a culture of quality, compliance, and operational excellence beyond the company boundaries
• Anticipate regulatory trends and industry standards to proactively adapt strategies and ensure ongoing compliance and competitiveness.

• ESO ownership:
• Responsible for oversight the quality performance of the CMOs with corresponding KPIs set. Provide front-line support to manage all quality related issues Implement and promote continuous improvement initiatives such as Lean, Six Sigma, or Kaizen to enhance operational efficiency and quality performance.
• Co-design and implementation of ESO QMS that comply with Acino standards and local regulations and all regulations of the respective countries in which the products are marketed. Leverage advanced technologies and digital tools to monitor and improve quality performance across the supply chain.
• Oversighting and monitoring of the qualification status of CMOs in scope of global ESO. Ensure ongoing training and development programs for CMOs to maintain high standards of quality and compliance. Develop strong relationships with CMOs to foster collaboration and ensure alignment with quality objectives.
• Co-design and participation in central working groups (in the Acino Group, as required) e.g. Quality Review Board, Corporate Quality Review Board, Safety Board and other ad hoc meetings. Incorporate customer feedback into quality improvement processes to ensure products meet or exceed customer expectations.
• Escalation of quality issues in accordance with applicable Acino quality directives. Proactively identify and mitigate risks associated with CMO operations to ensure consistent quality and compliance.
• BD&L:
• Collaborate with the BD&L team to assess potential business development opportunities and perform due diligence activities.
• Provide strategic input on quality and compliance aspects during the evaluation of new product acquisitions, partnerships, and licensing agreements.
• Ensure compliance with regulatory requirements and company quality standards throughout the BD&L process
• Conduct thorough risk assessments to identify potential quality and compliance risks associated with new business opportunities, acquisitions, partnerships, and licensing agreements.
• Perform quality due diligences of potential partners and acquisition targets to ensure they meet the company's quality standards and regulatory requirements.
• Develop and implement quality integration plans for new acquisitions and partnerships to ensure a seamless transition and maintain high-quality standards.
• Stay informed about regulatory changes and industry trends that may impact BD&L activities and provide guidance to the team accordingly.
• Ensure that all quality-related documentation and records are accurately maintained and readily available for regulatory inspections and audits.
• Provide training and support to the BD&L team on quality and compliance matters to enhance their understanding and ensure alignment with quality objectives.
• Transfer Project Management
• Oversight of product transfers between sites, including technology transfers and manufacturing process transfers.
• Develop and implement effective transfer strategies, ensuring compliance with regulatory requirements and adherence to project timelines.
• Collaborate with cross-functional teams to resolve technical and quality-related issues during transfer activities.
• Product Launch Strategy
• Collaborate with stakeholders in quality functions and ensure launch requirements, timelines, and quality objectives.
• Drive continuous improvement initiatives to enhance launch processes and mitigate risks
• Supply Chain Distribution
• Ensure global distribution processes comply with all relevant regulations
• Evolve SOPs, quality agreements and policies for warehousing and logistic partners
• Qualify and monitor Third party Logistics and external distributions partners

• Oversee product complaints and investigations, ensuring timely resolution and effective root cause analysis.
• 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.
• Lead compliance with global regulatory requirements (FDA, EMA, MHRA, WHO, etc.) and ensure adherence to GMP, GDP, and quality standards.
• Oversee quality risk management, identifying and mitigating risks related to product quality, supply chain, and distribution.
• Partner with regulatory affairs to maintain product licenses, handle regulatory inspections, and address market compliance issues.
• Develop and implement quality standards, policies, and procedures for BD&L, transfers, and launches.
• Conduct internal audits and oversee the resolution of non-conformities and corrective actions

• Strategic Thinking: Ability to set a long-term strategic vision while executing immediate priorities.
• Change Management: Proficiency in leading organizational change and foster a culture centred on quality and compliance, and ensuring employee engagement.
• 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.

• Degree in Pharmaceutical Sciences, Chemistry, or related field; advanced degree preferred;

• Experience in Auditing is a plus;
• 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.

Acino