Senior Director, Quality Control (QC)
About The Position
The Senior Director, Quality Control (QC) serves as the strategic and technical leader for Xeris’s outsourced GxP testing operations supporting clinical and commercial products. The role operates within a contract manufacturing and testing ecosystem and does not manage internal laboratories. It establishes frameworks, compliance systems, and strategic direction for an external network of GxP testing laboratories supporting raw materials, APIs, intermediates, finished drug products, and delivery devices. The position builds and oversees efficient, compliant QC systems that interface with the independent Quality Assurance (QA) unit to support product safety, efficacy, quality, and regulatory compliance across clinical and commercial programs. It collaborates with internal PDTO groups, including Manufacturing Science & Technology and Commercial Manufacturing & Supply Chain Logistics; departments such as QA, Regulatory Affairs, Finance, and Legal; product development and project teams; and external partners. The Senior Director functionally supervises, mentors, and develops junior QC staff; leads external laboratory strategy and performance oversight; governs release and stability testing, investigations, reference standards, reagents, raw-material testing, analytical methods, specifications, material qualification, and retains programs; and provides QC expertise to QA and regulatory activities. The role has QC accountability for data integrity and analytical and specification content in global regulatory documentation, supports inspection preparedness, represents Xeris in regulatory interactions, and drives QC goals, budgets, and strategy. The position is based at Xeris’s Chicago headquarters, requires at least four days per week in the office, and may involve evening, weekend, and overnight travel as needed.
Requirements
- Bachelor’s degree in biotechnology, chemistry, or a related field.
- 18 or more years of experience.
- At least 12 years of experience working in a QA/QC environment in the pharmaceutical industry.
- Demonstrated expertise working in a GxP environment supporting both clinical-stage and commercial products.
- Deep understanding of Quality Systems supporting investigations, quality events, and CAPAs.
- Ability to foster effective working relationships with R&D scientists, engineers, and technical professionals in Regulatory Affairs and QA.
- Proficiency with Microsoft Word, PowerPoint, Outlook, and Excel; web-based software; and document management and stability tracking software.
Nice To Haves
- An advanced technical degree.
Responsibilities
- Functionally supervise, mentor, and develop junior QC staff; delegate work and ensure efficient, compliant administrative workflows for routine data entry and document archiving.
- Establish frameworks for evaluating, selecting, and monitoring contract laboratories, and provide strategic oversight of commercial relationships, contract negotiations, purchase orders, and invoicing workflows.
- Provide strategic oversight of clinical and commercial release and stability testing programs, including sample shipments, stability protocol execution, analytical data and CoA review and approval, data archiving, and stability data tracking, trending, and peer review.
- Direct the strategic resolution and compliance framework for laboratory OOS and OOT investigations at testing facilities and own relevant CAPAs.
- Establish and oversee lifecycle management and controls for reference standards and critical reagents across the external testing network.
- Coordinate the testing, evaluation, and release strategy for critical raw materials, including APIs, excipients, packaging components, and delivery devices.
- In coordination with Analytical Development, oversee and govern analytical method validations and transfers from Xeris to external contract testing laboratories.
- In coordination with Analytical Development, develop and manage systems for establishing, justifying, and updating product specifications, and present periodically to Xeris’s Specifications Committee.
- Oversee the framework and compliance standards for material qualification and requalification across the supply chain.
- Provide the QA unit with strategic auditing support and technical QC expertise as a subject matter expert.
- Ensure integrity and traceability of data supporting regulatory applications; review and hold ultimate QC accountability for analytical and specification sections of global regulatory documentation, including INDs, IMPDs, NDAs, BLAs, and MAAs.
- Establish and oversee the framework for Xeris’s retains program.
- Identify potential compliance vulnerabilities and risks, and lead corrective action plan development and implementation to ensure conformity with regulatory commitments and regulations.
- Support regulatory inspection preparedness for internal operations and external partners, contribute to regulatory submission preparation and review, and represent Xeris in QC-related interactions with the FDA, EMA, and other regulatory agencies.
- Drive QC goal setting, budget development, and strategy in alignment with corporate goals.
- Review and approve Quality Agreements and QC-related contracts, protocols, and reports.
- Build effective working relationships with internal teams, technical professionals, and external partners.
Benefits
- Competitive compensation.
- Equity or long-term incentive awards, where applicable.
- Annual bonus eligibility for non-sales employees.
- Paid time off benefits.
- Health insurance options.
- Vision insurance options.
- Dental insurance options.
- 401(k) retirement benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
