Job Description:

The Senior Director, Quality Control (QC) serves as the strategic and technical anchor for Xeris's outsourced GxP testing operations associated with both clinical and commercial products. Operating strictly within a contract manufacturing and testing ecosystem, this role does not manage internal laboratories. Instead, the Senior Director establishes the overarching frameworks, compliance systems, and strategic direction for an external network of GxP testing laboratories supporting the Company's products (including raw materials, APIs, intermediates, finished drug products, and delivery devices).

The primary mandate for this leader is to build and oversee robust, highly efficient and compliant QC systems that interface seamlessly with the independent Quality Assurance (QA) unit, ensuring product safety, efficacy, and quality along with regulatory compliance across all clinical and commercial programs. This position is also responsible for collaborating with internal groups within PDTO (eg, Manufacturing Science & Technology, Commercial Manufacturing & Supply Chain Logistics, etc.), other departments (eg, QA, Regulatory Affairs, Finance, Legal, etc.), a range of product development and project teams, along with Xeris' external partners to provide expert level QC guidance and direction.

Essential Job Functions

• Group Leadership & Delegation: Functionally supervise, mentor, and develop junior QC staff. Effectively delegate tactics, while ensuring efficient and compliant administrative workflows for junior staff to manage routine data entry (eg, SLIMStat) and document archiving (eg, Veeva).
• External Network Strategy & Vendor Management: Establish the framework for contract lab evaluation, selection, and ongoing performance monitoring. Provide strategic oversight of the commercial relationship, including the negotiation of contracts and the establishment of efficient administrative workflows for purchase orders and invoicing.
• Release & Stability Frameworks: Provide strategic oversight for all clinical and commercial release and stability testing programs. Establish robust, compliant systems to ensure the seamless coordination of sample shipments, the rigorous execution of annual marketed product and ICH pipeline product stability protocols, the technical review and approval of analytical data/Certificates of Analyses (CoAs), the compliant archiving of data via our document management systems (eg, Veeva), and the tracking, trending, and transparent peer reviews of stability data via SLIMStat.
• Investigation Governance: Direct the strategic resolution and compliance framework for all laboratory out-of-specification (OOS) and out-of-trend (OOT) investigations occurring at our testing facilities along with ownership of relevant Corrective and Preventive Actions (CAPAs).
• Reference Standard & Reagent Programs: Establish and oversee the lifecycle management system and controls for reference standards and critical reagents across the external testing network.
• Raw Material Testing Strategy: Coordinate the overarching strategy for the testing, evaluation, and release of critical raw materials, including APIs, excipients, packaging components, and delivery devices.
• Analytical Methods Validations and Transfers: In close coordination with our Analytical Development functions, provide strategic oversight and governance for all analytical method validations and analytical method transfers from Xeris to external contract testing laboratories.
• Specification Management: In close coordination with our Analytical Development functions, develop and strategically manage the internal systems for establishing, justifying, and updating product specifications, along with periodic presentations to Xeris' internal Specifications Committee.
• Material Qualification Systems: Oversee the structural framework and compliance standards for the qualification and requalification of materials across the supply chain.
• QA Partnership & Auditing: Serve as the definitive technical Subject Matter Expert (SME), providing strategic auditing support and partnership to the QA unit where advanced analytical and QC expertise is required.
• Regulatory Accountability & Data Integrity: Ensure the absolute integrity and traceability of data supporting regulatory applications. Provide strategic review and ultimate QC accountability for the analytical and specification sections of global regulatory documentation (INDs, IMPDs, NDAs, BLAs, MAAs).
• Retains Programs: Establish and oversee the framework for Xeris' retains program.
• Identify potential areas of compliance vulnerability, and risk; lead development and implementation of corrective action plans for resolution to ensure conformity with regulatory commitments and regulations.
• Help ensure regulatory inspection preparedness for both internal operations and external partners and contribute to the preparation and review of regulatory submissions. Represent Xeris in interactions with FDA, EMA, and other regulatory agencies on QC-related topics.
• Drive goal setting, budget development, and strategy for QC in alignment with corporate goals.
• Review and approve Quality Agreements and QC-related contracts, protocols, and reports.

Skills and Qualifications

• Bachelor's degree in biotechnology, chemistry, or related field with 18+ years of experience and at least 12 years of experience working in a QA/QC environment in the pharmaceutical industry. An advanced technical degree would be advantageous.
• Demonstrated expertise working in a GxP environment in support of both clinical-stage and commercial products.
• Deep understanding of Quality Systems in support of investigations, quality events, and CAPAs.
• Ability to foster effective working relationships with R&D scientists, engineers, as well as technical professionals in Regulatory Affairs and QA.
• Proficient with use of Microsoft Word, PowerPoint, Outlook, and Excel and web-based software for various applications, as well as document management and stability tracking software.

Working Conditions

• Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel may be required.
• This position is based in Xeris' Chicago Headquarters and requires a minimum of four days per week in the office. On-site requirements may change at management's discretion.

The anticipated base salary range for this position is $252,900 to $337,200.

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We are committed to offering competitive compensation. Starting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable.