Senior Compliance & Quality Assurance Consultant

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.

• 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.

• 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.

Pro Pharma is an Equal Opportunity Employer.