AD, Corporate Compliance
SUMMARY DESCRIPTION
This position manages the GMP assessment function. The function ensures manufacturers of materials and services used in the manufacture and distribution of biological and small molecule products operate in accordance to applicable regulatory, and company requirements. The function leads, or facilitates external and internal audits including contract manufacturing services ensuring the quality, safety and reliability of the final product.
RESPONSIBILITIES
• Enhancement and implementation of corporate compliance
systems/procedures
• Develops and executes a GMP compliance staff training plan to support
department growth
• Development, maintaining and executing the internal and supplier
assessment audit plan.
• Lead internal audit teams
• Lead assessment of contract manufacturing organizations, distributors, raw
material and component suppliers, contract testing laboratories and
software development audit teams
• Assist in the development and implementation of budgets for the GMP
compliance Department
• Provide leadership during Regulatory and partner inspections
• Oversee tracking of regulatory commitments (including regulatory
inspectional findings and post market commitments
• Ensure Senior/Executive Management is kept abreast of significant issues or
developments identified during compliance risk assessment activities, as well
as actions being taken to improve the situation
• Leads quality systems enhancement and/or improvement initiatives
• Oversee day-to-day activities of non-medical product complaints for small
molecule and biological products
• Ensures appropriate data collection and preparation of metrics for
compliance index.
• Has responsibility for regulatory inspection and partner audit co-ordination
and support.
• Routine periodic reporting to management regarding audit/inspection
findings and corrective action progress, as well as overall GMP compliance
risk.
• Customarily and regularly exercises discretion and independent judgment in
the performance of the duties described above.
• Performs under only general supervision work along specialized lines
requiring special training, experience and knowledge.
• Other duties as assigned.
EDUCATION
• Requires a BS in scientific discipline or related field
EXPERIENCE
• +5 years applicable experience with at least 3 years experience in global
GMP compliance in the biotech or pharmaceutical industry.
• Experience with FDA, EMEA and other foreign regulatory inspection
groups is highly desired.
• Auditing experience required, lead auditor certification is a plus
• Supervisory experience is desired
• Excellent written and verbal communication skills are required
EQUIPMENT
Fluent with Microsoft Office suite programs (Word, Excel, PowerPoint, Access)
CONTACTS
Quality Assurance, Quality Control, Manufacturing, Manufacturing Support, Facilities, Regulatory Affairs, Clinical Sciences, Purchasing and Contract Manufacturing
SUPERVISOR RESPONSIBILITY
This position has no direct reports, however, the incumbent must be able to lead projects in a matrix organization environment represented by a diverse set of personalities. The success of this position is dependent upon negotiating compliant policies and procedures in other departments.