Cpl Life Sciences as partnered with a global pharmaceutical organisation to source for an Associate Director, EMEA Clinical Quality Assurance (CQA), the candidate will lead as the GCP Subject Matter Expert (SME) on the development team, ensuring regulatory and quality compliance with GCP standards and other relevant regulatory requirements. This role involves both internal and external collaboration to uphold compliance across systems, processes, and outcomes in alignment with international and national standards.
Key Responsibilities:
• Act as GCP and EMEA regulation SME.
• Contribute to and support a risk-based, scientifically-driven quality system for supporting GCP compliance.
• Design, develop and implement a strategic audit plan, conduct audits of investigator sites, vendors, and internal systems, ensuring compliance with SOPs and regulations.
• Lead the assessment and approval of vendors for potential use, offering guidance and oversight to ensure alignment with company quality and compliance standards.
• Collaborate cross-functionally to address and mitigate GCP quality and compliance issues.
• Ensure adherence to the ICH E6 Guideline for Good Clinical Practice and mentor staff to enhance quality and auditing skills.
• Manage quality documentation in Veeva QMS and Vault.
• Represent the company in regulatory inspections.
Requirements:
• BS in Biology, Chemistry, or related life sciences degree with at least 7-10 years of experience, or advanced degree (MS, PhD, MBA) preferred with additional equivalent experience.
• Experience with managing regulatory inspections, collaborating with regulators and internal staff for inspection preparation.
• Biologics experience preferred.
• Experience with SOP development relevant to clinical, regulatory and medical processes.
• Proficiency with GCP auditing, including external investigator sites, CROs, supporting laboratories, and responsibility for audit reporting, reviewing and tracking CAPAs.
• Proficient in GCP and EU clinical regulations, and risk-based quality systems aligned with ICH E6.
• Significant GCP audit experience, including audit reporting and CAPA tracking.
• Extensive knowledge of Phases I-IV (especially Phase III), with preference for regulatory approval, NDAs, and MAAs experience.
• Highly organized, collaborative, and adaptable, with an attention to detail and accuracy.
• Demonstrating values of respect, passion, integrity, collaboration, and accountability.
• Able to travel domestically and internationally (25-30%).
If interested, please send your CV to arshaan.sindhwani@cpl.com