Quality Systems Lead
Quality Systems Lead
Job Description Summary
This role leads the Quality System for R&D operations, ensuring compliance with global regulations while driving continuous improvement. It is responsible for developing and maintaining effective quality processes, assessing risk, implementing modern quality practices, and supporting teams through clear communication, training, and cross-functional collaboration.
Role Overview
Reporting to the Head of R&D Quality, this position is accountable for the implementation, oversight, and maintenance of quality assurance activities at the Consumer Healthcare Innovation Center. The role partners closely with stakeholders and subject matter experts to ensure R&D policies and procedures are fit for purpose, compliant with internal and external requirements, and effectively applied across the organization.
The position evaluates regulatory and industry trends to ensure global compliance and applicability across multiple product categories, including medicines, medical devices, food, and cosmetics. It also promotes a continuous improvement mindset by identifying efficiencies, accelerating speed to market, and strengthening operational resilience.
This role serves as a key regulatory subject matter expert, representing R&D in global quality initiatives while supporting regional and local teams with operational execution and audit readiness.
Key Responsibilities
- Lead and manage site-level quality assurance activities, ensuring compliance with global standards and internal policies
- Oversee implementation and continuous improvement of quality systems and procedures
- Act as a subject matter expert on regulations, supporting audit readiness and compliance initiatives
- Evaluate regulatory and industry trends to maintain globally applicable and compliant processes
- Identify and scale robust quality practices across sites to enhance resilience and consistency
- Serve as the Consumer Health Global CAPA Manager, driving closure of compliance gaps and improvements across Regulatory, Medical, Safety, Quality, and Compliance functions
- Plan, conduct, and manage internal and external audits, including third-party manufacturers and laboratories
- Lead and support GxP compliance inspections conducted by regulatory agencies
- Track quality metrics, identify trends, and drive corrective and preventive actions
- Partner with leadership and cross-functional teams to deliver continuous improvement and operational excellence
Collaboration
Works closely with site leadership, subject matter experts, regulatory teams, corporate quality, external suppliers, and industry working groups to ensure alignment and compliance.
Qualifications
- Background in life sciences
- Experience in quality assurance, quality control, or manufacturing within regulated industries
- Strong knowledge of global regulations and quality standards (GxP, ISO, ICH)
- Certified Project Management Professional (PMP) preferred
- Proven ability to manage audits, inspections, and compliance activities
- Demonstrated success driving change and delivering measurable results in fast-paced, complex environments
- Strong organizational skills with a structured and process-oriented approach
- Excellent communication and teamwork skills, with the ability to collaborate across matrixed teams
- Familiarity with continuous improvement methodologies such as Lean, Six Sigma, or Kaizen
Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.
If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.
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