Senior Compliance Specialist
Job Description:
We are seeking a Senior Compliance Specialist to execute the internal audit program, prepare and lead external audits, provide compliance subject matter expertise, and deploy compliance initiatives at our manufacturing site.
The ideal candidate will have at least 5 years of related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience. A solid understanding of global GMP regulations is required.
Key Responsibilities:
* Implement and execute internal audits program at the site (schedule, agenda, prepare and conduct audit, report writing, review of internal audits investigation responses).
* Responsible for training and qualifying auditors.
* Facilitate and support external GMP audits and inspections (Health Authority, Customer), including the coordination of inspection back room.
* Inspection Readiness: lead compliance walk-throughs, audit preparation, coaching the SMEs.
* Provide compliance subject matter expertise and compliance training to the manufacturing site, including identifying changes in regulations that impact procedures and current practices.
* Implement compliance initiatives and projects at the site, in alignment with Global Innovative Medicine Regulatory Compliance (IMRC).
* Partner with site to proactively identify risks and drive compliance improvement across the site.
* Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations.
* Ensure timely and accurate reporting of compliance metrics.
Qualifications:
* Education: A minimum of a Bachelor's Degree or equivalent experience in Science or related field.
* Experience and Skills Required:
o At least 5 years related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience.
o Solid understanding of global GMP regulations.
o Experience preparing, handling and/or supporting inspections.
o Strong analytical skills and ability to clearly articulate issues.
o Excellent interpersonal skills, able to quickly build credibility with the site and within the Quality and Compliance community.
o A creative, flexible approach to new challenges