OVERVIEW

The Director, Quality Assurance is responsible for the coordination of the Product Quality Management Program. The Director will work with the broader quality unit and technical operations departments (product development and commercial manufacturing) to maintain and improve the overall Product Quality Management Program, including developing a clear mission and vision for supplier quality management (SQM) and providing quality assurance oversight of product related changes, deviations and complaint investigations, batch review and release, technology transfer and process validation. The individual will also be responsible for ensuring the maintenance of global policies, procedures, quality agreements, forms and templates and supplier performance metrics to international regulatory requirements (e.g. FDA, EU and ISO).

QUALIFICATIONS

• A minimum of a bachelor’s degree required in Engineering, Sciences or other related fields.
• 8-10+ years in quality, compliance, and pharmaceutical supplier quality management, including GXP facility audits, in a regulatory environment (FDA, MHRA, Notified Body, etc) required
• Competencies: Functional Leadership, Presentation skills, Teamwork & Collaboration, Attention to Detail, Self-Starter, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications, Analytical skills, Decision-making skills
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid role based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management’s discretion. Travel up to 25 – 40%

#LI-HYBRID

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $170,000 - 230,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. 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 process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

• Provide Product Quality Management oversight of the Global SQM processes.
• Manage Product Quality SQM standards including: supplier identification and selection; supplier evaluation and approval; supplier quality agreements; supplier performance monitoring and supplier relationship management.
• Coordination and participation in supplier / vendor audits and global approved supplier list(s) in conjunction with the Quality Unit and Technical Operations departments.
• Manage Pre-approval Inspection Readiness.
• Work with the Regulatory Affairs and Quality Unit departments in facility Heath Authority Inspections.
• Manage quality impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
• Work with business, regional, and third party plant quality representatives to drive product quality management programs across the globe.
• Establish and maintain a database for the management and tracking of supplier performance (e.g. scorecards)
• Provide quarterly reporting of supplier quality metrics to the Quality Management Review Chair.
• Ensure the review, approval and retention of Master and Executed Batch Records for API and drug product
• Ensure the review, approval and retention of Validation Master Plans including protocols and reports (API, Drug product process validation and analytical method validations)
• Provide quality oversight and support to technology transfer, process validation and product risk management
• Partner with Technical Operations department on the execution and continuous improvement of the SQM program, including tactical support and problem-solving initiatives with suppliers.
• Ensure monitoring of watch lists and regulatory notices of field action for suppliers.
• Oversee the management of change for development and commercial products
• Oversee the investigation of deviations and complaints associate with development and commercial products
• Other duties as assigned by the Vice President of Quality.