Sr. Director, Quality Control

Xeris Pharmaceuticals•Chicago, IL

1d•Hybrid

About The Position

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.

Requirements

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.
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.

Nice To Haves

An advanced technical degree would be advantageous.

Responsibilities

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).
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.
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.
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).
Establish and oversee the lifecycle management system and controls for reference standards and critical reagents across the external testing network.
Coordinate the overarching strategy for the testing, evaluation, and release of critical raw materials, including APIs, excipients, packaging components, and delivery devices.
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.
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.
Oversee the structural framework and compliance standards for the qualification and requalification of materials across the supply chain.
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.
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).
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.