Director of Quality
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Job Location:
Gulfport, MS - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Director of Quality Pharmaceutical Manufacturing
Position Type: Full-Time
Work Schedule: Onsite
Industry: Pharmaceutical Manufacturing
Function: Quality Assurance / Quality Control Leadership
Position Summary:
The Director of Quality provides strategic and operational leadership for all Quality Assurance and Quality Control activities at an FDA-regulated pharmaceutical manufacturing site. The role oversees development implementation and maintenance of a compliant cGMP Quality Management System supporting commercial liquid and solid dose production.
This position serves as the sites primary quality authority and regulatory representative.
Responsibilities:
- Lead site Quality Assurance and Quality Control organizations
- Maintain Quality Management System compliant with 21 CFR 210/211
- Final approval authority for batch disposition and product release
- Manage:
- Deviations & investigations
- CAPA programs
- Change control
- Complaint handling
- Support regulatory inspections and audits as lead quality representative
- Ensure ongoing inspection readiness
- Partner with Manufacturing Technical Operations and Executive Leadership
Qualifications:
- Bachelors degree in Life Sciences or related field (advanced degree preferred)
- 10 years pharmaceutical manufacturing quality experience
- Prior leadership responsibility over QA and QC teams
- Strong working knowledge of FDA regulations and cGMP requirements
- Experience in commercial manufacturing environments
- Demonstrated regulatory inspection leadership
Additional Information:
- Onsite leadership role
- Reports to senior executive leadership
- Opportunity within a stable long-standing manufacturing organization
Key Skills
- Crisis Management
- Marketing
- Public Relations
- Fundraising
- Media Relations
- Constant Contact
- Strategic Planning
- Social Media Management
- Team Management
- Public Speaking
- Wordpress
- Writing Skills
