Senior Director, Quality Control (QC)

Job Description:

The Senior Director Quality Control (QC) serves as the strategic and technical anchor for Xeriss 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 Companys 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

• Bachelors 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 managements discretion.

The anticipated base salary range for this position is $252900 to $337200.

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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.

Xeris Pharmaceuticals Inc. (the Company) is an equal opportunity employer and does not discriminate based on race color religion sex gender identity sexual orientation national origin age disability veteran status genetics or any other characteristic protected by law. All qualified candidates are given equal opportunity and the Companys employment selection decisions are based solely on job-related : This job description is not intended to be all-inclusive. The employee may be required to perform other related duties as needed to meet the ongoing needs of the Company.

The level of the position will be determined based on the selected candidates qualifications and experience. Final determination of the actual base salary offered depends on several factors including but not limited to the candidates skills experience education location and business needs. Employees are eligible for equity or long-term incentive awards where applicable. Field Sales role employees are eligible for a quarterly commission structure. Non-Sales role employees are eligible for an annual bonus. The Company also offers a comprehensive benefits package that includes additional elements such as paid time off benefits various health vision and dental insurance options 401(k) retirement benefits and more for eligible employees. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview hired as temporary employees interns and preceptors are not eligible for commissions bonuses and/or long-term incentive or equity awards. Eligibility for other benefits will be based on plan documents.

Accessibility & Reasonable Accommodations

If because of a medical condition or disability you require a reasonable accommodation or assistance to complete any part of the application process please send an e-mail to and identify the type of accommodation or assistance you are requesting. Please include the job requisition number in your message. Please note if your request is not for this stated purpose you will not receive a response to your email. Do not include any medical or health information in this email.

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