Overview
Senior Compliance & Quality Assurance Consultant Jobs in Overland Park, USA at PPG US ProPharma Group, LLC
Responsibilities
- Act as a Subject Matter Expert in quality assurance and regulatory/GxP areas.
- Provide independent consultation and manage projects within the CQA business practice.
- Support execution of the strategy for the CQA service line, ensuring project profitability and monitoring personnel performance.
- Stay current with regulatory and technological changes in the CQA field and develop expertise to enhance company effectiveness.
- Contribute to the implementation and successful execution of risk‑based and phase‑appropriate GxP projects.
- Participate in the sales process as an SME, identifying scope and effort required to address client needs.
- Promote CQA services through presentations, social media content, and blog development.
- Advocate for continuous improvement of customer satisfaction with emphasis on CQA consulting services.
- Deliver CQA‑specific training to clients and associates in other business units.
- Support clients and functional units when GxP issues such as deviations and non‑conformances arise, and consult on CAPA implementation.
- Ensure compliance of company operations with quality principles and contribute to the development of quality systems through SOP writing and training.
- Maintain a percentage of billable work as determined by the service line budget tiers.
Qualifications
- Strong knowledge of applicable US FDA, ICH, EMA, and MHRA regulations and guidance documents.
- High-level expertise in GxP systems with the ability to provide independent consultation based on experience.
- Ability to earn and maintain client confidence through effective planning, organizing, and project direction.
- Willingness and ability to travel as required.
- Strong interpersonal, written, and oral communication skills.
- Ability to manage and execute multiple tasks across quality assurance, regulatory, and related life science consulting services.
- Quality orientation, high attention to detail, and strong analytical skills.
Education & Experience
- Bachelor’s degree in a scientific discipline (minimum) or equivalent.
- Graduate degree (MSc/PhD) in a scientific discipline (preferred).
- Minimum 10 years of relevant experience in quality assurance and regulatory/GxP compliance.
- Minimum 3 years managing a technology business, business unit, or serving as a CQA SME lead (preferred).
- Minimum 3 years of recent experience leading audits (preparation, execution, reporting).
- Audit log that reflects at least five audits performed per year.
- Strong preference for candidates with experience in a QC laboratory, preferably chemistry/analytical.
EEO Statement
Pro Pharma is an Equal Opportunity Employer.
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Title: Senior Compliance & Quality Assurance Consultant
Company: PPG US ProPharma Group, LLC
Location: Overland Park, USA
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