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This role leads the quality and regulatory function for a sterile pharmaceutical and medical device manufacturing site, with a strong focus on transformation and long-term performance. It is not a maintenance role—this position is responsible for rebuilding and strengthening core quality systems, improving inspection readiness, and establishing a more effective and scalable operating model. The Site Head of Quality owns all aspects of site compliance, including cGMP, ISO, and global regulatory requirements, and serves as the primary point of contact for inspections and regulatory agencies. The role oversees batch release, product disposition, and regulatory submissions, while ensuring quality systems support operational performance, customer commitments, and production timelines.
This position is responsible for leading large-scale quality initiatives, including redesigning CAPA processes, strengthening change control systems, and elevating aseptic and sterile manufacturing quality programs such as environmental monitoring, contamination control, and process validation. The role builds and leads the site quality organization across QA, QC, regulatory, validation, and document control, while guiding the transition from external support to internal ownership. It also establishes governance structures, drives a strong quality culture, and leads all customer and regulatory audits to successful outcomes.
Candidates should bring significant experience in quality leadership within sterile (aseptic or terminal) manufacturing environments, including direct responsibility for site-level quality functions. A strong track record of leading quality system transformations, supporting FDA inspections, and managing complex regulatory environments is required. This role also requires deep knowledge of cGMP standards, aseptic/terminal processing, and validation programs, along with proven ability to build teams, lead change, and drive measurable improvements in quality and compliance performance.
The anticipated base salary range for this position is $200,000 - $300,000 annually and would require relocation to the Chicago area. This position includes a comprehensive benefits package with medical, dental, and vision coverage, retirement savings, and paid time off, as well as other compensation, including bonus opportunities. Final compensation will be determined based on a variety of factors, including the candidate's experience, qualifications, market conditions, and the overall scope and responsibilities of the role at time of hire.