Job Title: Senior Manager, Regulatory Compliance & ProcessLocation: Warsaw, PolandArrangement: Hybrid (30% at the office)Contract Type: Independent Contractor / FreelanceEngagement: Full-Time ContractCompany OverviewApsida Life Science is partnering with a global biopharmaceutical company committed to advancing innovative therapies through scientific excellence, digital transformation, and a strong focus on quality and patient outcomes. As the organization continues to expand its global quality and regulatory capabilities, they are seeking an experienced Senior Manager, Regulatory Compliance & Process to support regulatory compliance, quality systems, and inspection readiness across GxP-regulated operations.Key Responsibilities:Manage controlled document governance within Veeva Quality/Veeva Vault, ensuring compliance with GxP requirements and global quality standards.Author, review, format, approve, and maintain SOPs, policies, work instructions, and other controlled quality documents.Oversee document lifecycle activities, including creation, revision, approval workflows, periodic reviews, archival, and retirement.Ensure documentation complies with FDA, EMA, MHRA, ICH, and internal quality requirements.Support continuous improvement of document templates, governance processes, and Veeva Quality workflows.Provide guidance to cross-functional teams on document control best practices and compliant use of Veeva systems.Support GxP training governance, including role-based curricula, training assignments, compliance monitoring, and Learning Management Systems (LMS).Monitor training compliance metrics and support remediation of overdue or non-compliant training records.Assess training impacts associated with new or revised procedures and quality initiatives.Support regulatory inspections, audits, and inspection readiness activities involving FDA, EMA, MHRA, and other global health authorities.Identify compliance risks and contribute to remediation plans following audits and inspections.Support and continuously improve Quality Management System (QMS) processes, including deviations, CAPAs, change controls, SOP management, document control, risk assessments, and training compliance.Analyse quality metrics and compliance trends to identify opportunities for operational excellence and continuous improvement.Collaborate with Regulatory Affairs, Quality, Clinical Operations, CMC, Pharmacovigilance, Medical Writing, and Digital teams to implement compliant and scalable quality processes.Required Qualifications:Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related scientific discipline.8+ years of experience in Regulatory Compliance, Quality Assurance, Regulatory Affairs, or other GxP-regulated functions within the pharmaceutical or biotechnology industry.Strong knowledge of FDA, EMA, MHRA, ICH, and global GxP regulations.Experience supporting regulatory inspections, audits, and inspection readiness activities.Hands-on experience with Veeva Vault Quality/Veeva Quality or a similar electronic document management system (eDMS).Experience authoring, reviewing, approving, and managing controlled quality documents and SOPs.Experience managing document lifecycle activities, including document control, approvals, periodic reviews, and archival.Experience supporting GxP training governance, training compliance, and Learning Management Systems (LMS).Strong understanding of Quality Management Systems (QMS), including CAPAs, deviations, change controls, risk assessments, and document management.Excellent communication, stakeholder management, and cross-functional collaboration skills.Ability to manage multiple priorities in a fast-paced, global environmentExperience within biologics, vaccines, mRNA, advanced therapeutics, or cell and gene therapy.If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science: kgmphahlele@apsida.com+44 744 134 1041Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process

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Senior Regulatory Compliance Manager