About the Role
The Site Self-Inspection Lead is responsible for ensuring compliance with Good Manufacturing Practices (GMP) and inspection readiness at manufacturing sites.
This involves leading self-inspections, conducting facility walk-throughs, and managing the self-inspection program, including scheduling, CAPAs, and training.
* Leads self-inspections, conducts facility walk-throughs, and manages the self-inspection program (scheduling, CAPAs, training).
* Supports regulatory inspection readiness, participates in global audits, and audits third-party suppliers.
* Serves as a key link between Site Leadership and Global Operations Auditing.
This role requires strong leadership, accountability, and organizational skills, with the ability to work independently and coordinate/participate in activities with Global functions across the organization.
Main Responsibilities
* Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda.
* Liaising with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedule and scope.
* Ensuring each self-inspection is appropriately recorded and communicated.
* Performing frequent unplanned and planned walk-through inspections of the facility.
* Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed.
Key Requirements
* A minimum of a primary or higher degree in Science, Engineering, or related field with 10+ years' experience in GXP environments, including Quality Assurance.
* Strong understanding of cGMP and global regulatory requirements, including relevant policies and procedures.
* Proven leadership, accountability, and strong organizational skills; capable of working independently.
* Deep knowledge of quality systems and ability to apply global GMP standards to improve site systems and processes.
* Skilled in negotiation and collaboration with stakeholders at all levels, including senior leadership.
Additional Information
This position offers competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact. Opportunities exist for professional growth and development within the organization.