Calliditas

The Vice President, Quality Affairs is responsible for establishing and maintaining the Company’s global pharmaceutical quality system and providing independent Quality oversight across its product portfolio and external GxP network. This role ensures that clinical and commercial activities are conducted in accordance with applicable global regulations, cGxP requirements, regulatory commitments, and Company standards while supporting the Company’s strategic and operational objectives. Operating within a fully outsourced model, the Vice President provides executive Quality leadership for product disposition, external partner oversight, quality-system governance, regulatory inspections, and the identification and management of significant quality and compliance risks. The role has the authority to escalate quality concerns, reject product, and suspend regulated activities when necessary to protect patients, product quality, data integrity, or regulatory compliance. Summary of Key Responsibilities: * Lead the development, implementation, governance, and continuous improvement of the Company’s pharmaceutical quality system, including management review, document control, training, change control, deviations, investigations, CAPAs, complaints, and product-quality review. * Provide independent Quality oversight of clinical and commercial manufacturing, testing, packaging, labeling, storage, and distribution activities performed by external partners. * Serve as the Company’s final Quality authority for batch disposition and release within delegated responsibilities, while ensuring compliance with market-specific requirements, including Qualified Person certification where required. * Ensure timely, risk-based review and approval of batch records, analytical results, deviations, investigations, change controls, CAPAs, specifications, validation documentation, and other records affecting product quality or disposition. * Provide Quality oversight of process and analytical changes, technology transfers, validation activities, new product introductions, product acquisitions, and post-approval changes. * Establish and maintain a risk-based lifecycle program for qualifying, auditing, monitoring, and requalifying CDMOs, contract laboratories, packagers, distributors, and other GxP suppliers. * Establish quality agreements and governance processes that clearly define responsibilities, communication requirements, performance expectations, and escalation pathways with external partners. * Monitor internal and external quality performance through meaningful metrics, management review, trend analysis, and partner governance; ensure significant risks and adverse trends are appropriately escalated and addressed. * Lead regulatory inspection readiness and serve as the primary Quality representative during inspections and health-authority interactions. Oversee the development and completion of inspection responses and remediation commitments. * Ensure appropriate oversight of data integrity, electronic records, computerized systems, and documentation practices within the Company and across its external GxP network. * Lead or support critical quality events, including significant investigations, product-quality complaints, recalls, market actions, and regulatory notifications. * Provide Quality expertise for business-development due diligence, licensing activities, product acquisitions, investigator-initiated studies, and promotional review, as applicable to the Company’s procedures and the role’s assigned scope. * Develop and manage the Quality Affairs budget, organizational capabilities, resource plans, and external support required to meet portfolio and corporate objectives. * Build and lead a high-performing Quality organization while fostering a culture of quality, accountability, compliance, transparency, and continuous improvement across the Company. Required Qualifications and Skills: * Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline; an advanced degree is preferred. * At least 15 years of progressively responsible Quality experience within the pharmaceutical or biotechnology industry, including significant leadership responsibility for commercial products. * Demonstrated experience leading Quality in a fully or substantially outsourced operating model, with oversight of CDMOs, contract laboratories, packaging and labeling providers, distributors, and other GxP suppliers. * Broad experience across multiple product modalities and manufacturing platforms. Experience with at least two of the following is strongly preferred: oral solid dosage forms, biologics, and oligonucleotide products. * Extensive experience with batch disposition, pharmaceutical quality systems, supplier quality, investigations, change control, CAPA, validation oversight, product complaints, and inspection readiness. * Strong knowledge of applicable global GMP and GDP requirements, including 21 CFR Parts 210 and 211, relevant EU regulations and GMP guidance, ICH guidelines, and applicable FDA and EMA expectations. * Experience interacting directly with regulatory authorities and successfully leading regulatory inspections, responses, remediation activities, and compliance commitments. * Demonstrated ability to make independent, risk-based product-quality and compliance decisions using sound scientific and regulatory judgment. * Experience leading managers and professional staff and establishing effective Quality governance across cross-functional and external-partner organizations. * Strong executive presence and the ability to communicate complex quality risks, recommendations, and decisions clearly to senior leadership, boards, regulators, partners, and technical teams. * Excellent leadership, negotiation, organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic environment. As a global organization, we are open to considering candidates in multiple locations. The position can be based either at our Stockholm, Sweden office or at our Cary, North Carolina office, depending on the selected candidate and the position reports to the Senior Vice President and Head of Pharmaceutical Operations & Technologies. About Calliditas Therapeutics The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Calliditas is an Asahi-Kasei Group Company based in Stockholm, Sweden. Calliditas’ lead product, developed under the name Nefecon, has received full approval by the FDA under the trade name TARPEYO® and by the European Commission under the trade name KINPEYGO®. TARPEYO/KINPEYGO® is the first treatment approved for IgA nephropathy by the FDA and EMA, respectively.

We are looking for an experienced and strategic leader to join our Pharmaceutical Operations & Technologies organization as Executive Director PO&T Asset Management. In this role, you will help translate business and functional strategies into clear priorities and an integrated portfolio of high-impact initiatives. You will work closely with senior leaders across Pharmaceutical Operations, Technology, Manufacturing, Quality, Supply Chain, Regulatory and Finance to ensure that strategic initiatives are effectively prioritized, resourced, governed and executed. Key responsibilities Strategy & Business Leadership * Provide input to the strategic roadmap for Pharmaceutical Operations & Technologies in alignment with overall company objectives. * Translate corporate and functional strategies into actionable priorities, programs, and measurable outcomes for PO&T by project. * Lead strategic planning processes, including annual operating plans, multi-year roadmaps, and strategic investment priorities. * Provide executive-level recommendations regarding priorities, resource allocation, investments, risks, and organizational capabilities. * Establish and lead an integrated portfolio management framework for all projects within PO&T. * Oversee a portfolio of complex, cross-functional programs from strategy and business case development through implementation and benefits realization for PO&T. * Ensure projects are appropriately prioritized based on strategic value, business impact, risk, complexity, and resource requirements for PO&T. * Establish governance structures, decision-making forums, performance metrics, and escalation mechanisms for PO&T. * Monitor portfolio performance, milestones, dependencies, risks, financial commitments, and resource utilization for PO&T. * Provide clear executive reporting and recommendations to ensure timely decisions and successful execution for PO&T. Operations & Technology Transformation * Lead strategic transformation initiatives designed to improve pharmaceutical operations, organizational effectiveness, technology capabilities, and business performance. * Identify opportunities to leverage digital technologies, data, automation, analytics, and innovative operating models for PO&T. * Partner with technology and business leaders to develop technology strategies that support operational and strategic objectives for PO&T. * Drive adoption of standardized processes, tools, governance, and best practices across PO&T. * Ensure transformation initiatives deliver measurable improvements in efficiency, quality, compliance, scalability, and business value for PO&T. Organizational Leadership * Build, develop, and lead a high-performing team of portfolio and strategy professionals for PO&T. * Establish a culture of accountability, collaboration, innovation, and disciplined execution. * Mentor project and program leaders and develop future organizational talent. * Establish clear roles, responsibilities, performance expectations, and career development pathways. * Serve as a trusted strategic partner to the executive leadership team and senior functional leaders for PO&T. * Facilitate alignment across business functions and resolve competing priorities, dependencies, and resource constraints. * Prepare executive-level presentations, portfolio reviews, strategic recommendations, and investment proposals for PO&T. * Represent Pharmaceutical Operations & Technologies in enterprise-level planning and governance forums. * Build strong relationships across internal stakeholders and external strategic partners. Financial & Resource Management * Partner with Finance and functional leaders to develop business cases, budgets, investment proposals, and financial forecasts. * Optimize allocation of people, capital, technology, and external resources across the strategic portfolio for PO&T. * Establish financial and value-delivery metrics for major programs for PO&T. * Ensure PO&T initiatives remain aligned with approved business cases and expected benefits. Risk, Compliance & Governance * Ensure strategic PO&T initiatives operate within applicable pharmaceutical, regulatory, quality, compliance, cybersecurity, and corporate governance requirements. * Establish proactive risk-management practices across the PO&T portfolio. * Identify and escalate significant risks, issues, dependencies, and decisions requiring executive intervention for PO&T. * Ensure appropriate documentation, governance, and accountability throughout the project lifecycle. Required Qualifications and Skills: * Bachelor’s degree in business, engineering, life sciences, technology, operations, or a related discipline. * 15+ years of experience in pharmaceutical, biotechnology, life sciences, healthcare, technology, operations, or a related industry. * Significant experience leading complex, enterprise-level programs and strategic initiatives. * Demonstrated experience in portfolio management, program management, operational strategy, or business transformation. * Proven ability to influence and lead across a complex, matrixed organization. * Experience presenting strategic recommendations and portfolio performance to senior executives. * Strong financial, analytical, organizational, and strategic-planning capabilities. Preferred * Advanced degree such as an MBA, MS, or equivalent preferred * Experience establishing or maturing a Project Management Office (PMO) or Enterprise Portfolio Management function. * PMP, PgMP, or equivalent program/project management certification. * Experience with enterprise transformation, organizational change, or operating-model design. As a global organization, we are open to considering candidates in multiple locations. The position can be based either at our Stockholm, Sweden office or at our Cary, North Carolina office, depending on the selected candidate and the position reports to the Senior Vice President and Head of Pharmaceutical Operations & Technologies. About Calliditas Therapeutics The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Calliditas is an Asahi-Kasei Group Company based in Stockholm, Sweden. Calliditas’ lead product, developed under the name Nefecon, has received full approval by the FDA under the trade name TARPEYO® and by the European Commission under the trade name KINPEYGO®. TARPEYO/KINPEYGO® is the first treatment approved for IgA nephropathy by the FDA and EMA, respectively.