QA Group Leader (Stability Studies)

The QA Group Leader (Stability Studies) leads a team of quality assurance professionals responsible for the review, verification, and approval of analytical data supporting R&D, method development, validation, and stability studies. This role ensures all reported data is scientifically sound, compliant, and inspection-ready, with a strong emphasis on data integrity, technical accuracy, and regulatory defensibility. The QA Group Leader acts as a critical bridge between Analytical Development and Quality Assurance, ensuring complex scientific data is accurately interpreted, thoroughly documented, and appropriately released.

Responsibilities

• Lead and mentor a team of QA professionals responsible for analytical data review for R&D, method development, validation, and stability studies.
• Review and approve analytical data packages supporting R&D, validation, and stability studies to ensure accuracy and completeness.
• Serve as the technical QA leader and primary escalation point for complex data review questions and issues.
• Ensure all documentation and data packages meet cGMP, FDA, and ICH requirements and are inspection-ready.
• Verify that all data is accurate, complete, traceable, and scientifically sound prior to release.
• Apply strong scientific judgment to assess method performance, data trends, and result validity in stability testing and analytical studies.
• Collaborate closely with Analytical Development and other scientific teams to ensure proper interpretation and documentation of complex scientific data.
• Support and oversee activities related to stability protocols, method transfer, and related QA processes.
• Contribute to or oversee investigations, deviations, and CAPAs to ensure appropriate documentation and resolution.
• Promote and uphold data integrity principles across all QA review activities and laboratory documentation.
• Utilize electronic quality and documentation systems, such as LIMS, to support efficient and compliant data review processes.
• Support client-facing or project-facing activities by providing clear, defensible QA input on analytical and stability data.

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field.
• 5 to 10 years of experience in a cGMP laboratory environment in QA or QC.
• Strong experience reviewing analytical data, stability studies, or method validation work.
• Solid understanding of cGMPs, FDA regulations, ICH guidelines, and data integrity principles.
• Demonstrated expertise in stability testing and stability studies within a pharmaceutical or laboratory setting.
• Proven ability to assess method performance, data trends, and result validity using strong scientific judgment.
• Experience working in R&D environments with a focus on analytical data review and method development.
• Ability to ensure documentation is accurate, complete, traceable, and scientifically sound.
• Strong attention to detail and commitment to regulatory compliance and inspection readiness.

• Advanced degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field is preferred.
• Previous supervisory or team leadership experience.
• Experience in a pharmaceutical, biotechnology, medical device, or contract laboratory/CRO/CDMO environment.
• Familiarity with stability protocols and their application in regulated environments.
• Experience with method transfer activities and related QA oversight.
• Exposure to investigations, deviations, and CAPAs, including documentation and follow-up.
• Experience with LIMS or other electronic quality and documentation systems.
• Client-facing or project-facing experience, including communication of QA findings and decisions.
• Background in laboratory operations and method development within pharmaceutical or related industries.

The work environment centers on a fully integrated laboratory setting that leverages modern information technology and automation to support rapid drug development and minimize human error in testing and analysis. The organization provides a full range of rapid testing and support services focused on pharmaceutical products and compounded sterile and nonsterile preparations, with development activities spanning multiple industries. Team members work closely with R&D, analytical development, and quality functions, using electronic quality systems such as LIMS and other documentation tools to manage data and ensure compliance. The culture emphasizes empowerment, professional growth, and career advancement, supported by continuous learning opportunities, mentorship, and leadership training. Employees benefit from flexible work arrangements, generous leave policies, and wellness programs designed to support work-life balance and overall well-being.

Job Type & Location

This is a Contract to Hire position based out of Vernon Hills, IL.

The pay range for this position is $40.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Vernon Hills,IL.

This position is anticipated to close on Jun 13, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $40 - $45