Overview

The Assoc. Director, Quality Assurance is responsible for the coordination of the Quality Management (SQM) Program and is a hands-on role providing support for all aspects of Quality Assurance for clinical and commercial products. The Assoc. Director will work with the unit and technical operations departments to maintain and improve the overall SQM strategy, including developing clear mission and vision for SQM and priority setting. The individual will also be responsible for developing and maintaining a standardized approach to SQM including global policies, procedures, quality agreements, forms and templates and supplier performance metrics that are compliant with all applicable international regulatory requirements (e.g. FDA, EU and ISO).

Responsibilities

• Oversee Global SQM processes with an immediate focus on global suppliers.
• Manage 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 supplier management programs across the globe.
• Maintain the database for the management and tracking of supplier information (e.g. Approved Supplier List) and monitoring of supplier performance (e.g. scorecards)
• Provide quarterly reporting of supplier quality metrics and audit schedule to the Quality Council Chair.
• Conduct thorough investigations and root cause analysis to identify and initiate appropriate corrective actions (CAPAs) in accordance with pre-established timelines.
• Participate in review of manufacturing and testing of new products to ensure quality compliance, and that all products meet or exceed customer requirements.
• Partner with Technical Operations department on the execution and continuous improvement of the SQM program, including tactical support and problem-solving initiatives with suppliers.
• Ensures monitoring of watch lists and regulatory notices of field action for suppliers.
• Develop and maintain Corporate SQM Policies and Procedures.
• Provide clinical quality oversite to ongoing and new studies as needed.
• Other duties as assigned by the Sr. Director of Quality.

Qualifications

• A minimum of a bachelor's degree required in Engineering, Sciences or other related fields.
• Minimum of 8 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.
• Some of the work performed is in a typical office environment and includes long periods of sitting at a desk as well as frequent usage of hands and computer.
• This position does require moderate amounts of walking, standing, bending, kneeling, stooping, pushing, pulling, reaching, lifting, and twisting.
• Employee may be required to exert up to 25 pounds of force occasionally
• Travel up to 25 – 40%

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.

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.