Director of Quality (Charlotte)

Director of Quality Assurance Site Investigations & Quality Systems

Our client, a global leader in the development and manufacturing of injectables, is looking for a Quality professional who can manage audits and quality systems at their manufacturing site.

POSITION SUMMARY :

This position is responsible for overall adequacy of all non-conformances investigations logged at site in respect to local and global procedures as applicable. Ensuring that the non-conformances are thoroughly investigated, root causes are substantiated, adequate and effective CAPAs are implemented.

The ideal candidate will be able to identify any atypical product quality trend and escalate in a timely manner to site and corporate level. This position will be an extension to implement corporate investigation and harmonization strategies and will represent the site.

Has been involved in handling USFDA inspections, responding to observations and well versed with Regulatory requirements. Under the direction of the Senior Director of Quality, this position is also responsible for implementing and managing the systems related to GxP compliance which includes, but is not limited to, the following systems : Document Control, Electronic Quality Management Systems (Investigation, Change Control, CAPA) and Annual Product Review (APR).

JOB RESPONSIBILITIES :

Financial :

• Participate in preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation, and management within approved budgets while building the site's best-in-class quality processes and systems.
• Maintain quality system controls to ensure no critical and major market complaints.

Operational Excellence :

Stakeholder :

Innovation :

Education :

Bachelor of Pharmacy or relevant science degree

Knowledge And Skill :

15-25 years in Pharmaceutical Industry - Investigations, Sterile Manufacturing Quality Assurance, Validation and Qualifications, Quality System and Compliance, Auditing, Good Distribution Practices, Sales and marketing

Education

Bachelor of Pharmacy or relevant science degree

Knowledge And Skill :

15-25 years in Pharmaceutical Industry - Investigations, Sterile Manufacturing Quality Assurance, Validation and Qualifications, Quality System and Compliance, Auditing, Good Distribution Practices, Sales and marketing