Manager, Quality Control - Chicago, IL

Overview · The Manager of Quality Control position is a hands-on role providing support for all aspects of Quality Control for clinical and commercial products. The position will provide expertise in drug substance (API), drug product and device analytical testing. Specifically, ...

Job description

Overview
The Manager of Quality Control position is a hands-on role providing support for all aspects of Quality Control for clinical and commercial products. The position will provide expertise in drug substance (API), drug product and device analytical testing. Specifically, the role will provide support to release and stability testing of products, including providing support to investigations related to OOS/OOT results, nonconformances, deviations and other product associated incidents. The role will also oversee or support stability programs related to mid-stage clinical to commercial programs. The position will ensure timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards. The Manager will effectively communicate results and issues to peers and management with excellent professional standards.

Responsibilities

• Manager Quality Control operations at contract sites (CDMO, CMO, Laboratories, etc.). Responsibilities include, but may not be limited to:
• Managing contract relationships
• Managing Contract Approval Forms, Purchase Orders and updates when required
• Participating in vetting and selecting appropriate contract testing labs through the Xeris supplier management process
• Supporting material qualification processes
• Supporting the coordination of testing of raw, intermediate, and final product through the global supply chain
• Managing analytical methods validation and transfer to/from contract testing labs
• Overseeing release and stability testing operations at contract sites
• Ensuring timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards
• Manage/validate SLIMstat software and trend manufacturing/stability data
• Participating in the preparation of analytical, testing, and specification sections of regulatory submissions and communications
• Adhering to CMC/QC budgets
• Support Mid/late Stage clinical and commercial stability programs. Responsibilities include, but may not be limited to:
• Supporting the clinical stability programs for Xeris mid-to-late stage products
• Supporting the commercial stability programs for Xeris commercial products
• Managing stability sample storage and testing at contract sites
• Managing API retain and reference standard storage
• Participating in the preparation of stability sections for drug substance and drug product sections of regulatory submissions

Qualifications

• Bachelor's/Master's degree in biology, chemistry, or similar discipline and 5+ years of experience working with pharmaceuticals/biopharmaceuticals, or Ph.D. and 5+ years' experience
• A minimum of 5 years in a supervisor or manager role in a GMP pharmaceutical/biopharmaceutical environment, including knowledge of analytical requirements for clinical-phase and commercial products
• Experience in Quality Controls and analytical method validation operations
• Solid understanding of Quality Systems in support of investigations and quality events
• Ability to effectively work with R&D scientists, CMC engineers, Supply Chain, Regulatory Affairs, and Quality Assurance functions
• Proficient with Microsoft Word, PowerPoint, Outlook, and Excel, as well as web-based software for various applications
• Experience in the use and application of statistical software. For example, SLIM, JMP, etc.
• Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation 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 requirements may change at management's discretion.

The level of the position will be determined based on the selected candidate's qualifications and experience.

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 $110,000 to $160,000. 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.

Job Locations
US-IL-Chicago
Title
Manager, Quality Control
ID

Category
Quality Control
Type
Full-Time