Senior Manager

The Senior Manager, GCP Compliance, oversees quality assurance and compliance activities supporting operational quality issues within Good Clinical Practice (GCP) domains. This role will serve as the primary Quality Event Manager for GCP-related events, ensuring compliance with regulatory standards and company policies. The successful candidate will collaborate cross-functionally to drive quality improvement and manage quality events from initiation through to resolution.

Key Responsibilities:

• Act as the primary Quality Event Manager for GCP-related quality events, ensuring thorough investigation, documentation, and timely resolution.
• Lead quality assurance processes and compliance activities to support the management of operational quality issues.
• Develop, implement, and maintain processes and documentation standards for GCP compliance to ensure regulatory requirements are met.
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, to address and resolve quality issues.
• Monitor GCP quality metrics and trends, conducting root cause analyses and implementing corrective and preventive actions (CAPAs) as necessary.
• Provide expertise and guidance on GCP compliance matters, ensuring adherence to internal policies and external regulatory standards.
• Lead internal and external audits as required, providing quality assurance expertise and supporting regulatory inspections.
• Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices in GCP compliance.
• Manage and mentor a team of compliance professionals, fostering a culture of quality and compliance across the organization.

Qualifications:

• Bachelor’s degree in life sciences, clinical research, or a related field; advanced degree preferred.
• Extensive experience in GCP compliance, quality assurance, and event management within the pharmaceutical or biotech industry.
• Demonstrated understanding of regulatory standards and guidelines, including ICH GCP and relevant FDA and EMA requirements.
• Proven track record of managing complex quality events, investigations, and CAPA processes in a GCP environment.
• Strong interpersonal and communication skills, with experience collaborating across functional teams.
• Leadership experience with the ability to manage and develop a team of quality and compliance professionals.
• Ability to adapt to changing regulatory requirements and provide strategic guidance on GCP compliance issues.

Additional Skills:

• Proficiency with quality management systems (QMS) and related software.
• Strong analytical and problem-solving skills, with attention to detail.
• Ability to work independently and as part of a team in a fast-paced, dynamic environment.