About the Company
Lead and oversee all quality operations within a pharmaceutical manufacturing environment by developing, implementing, and maintaining a cGMP-compliant quality system aligned with regulatory standards, customer requirements, and industry best practices.
About the Role
Responsible for establishing and maintaining a cGMP Quality Management System in compliance with 21 CFR regulations and U.S. Food and Drug Administration standards. The role ensures product quality, regulatory compliance, and continuous process improvement while leading quality teams and supporting organizational objectives.
Responsibilities
- Establish and maintain the Quality Management System and ensure ongoing cGMP compliance
- Audit quality processes, policies, and procedures to maintain operational control
- Develop and enforce procedures, protocols, and specifications, including third-party oversight
- Implement and monitor manufacturing in-process controls
- Review and approve/reject cGMP documentation, batch records, and product release decisions
- Lead investigations of deviations, nonconformance, and customer complaints with root cause analysis
- Report quality risks, system performance, and regulatory inspection outcomes to leadership
- Maintain independence in quality review and approval activities
Qualifications
- Bachelor's degree in Chemistry, Biology, or a related field
- 10+ years of management experience in pharmaceutical manufacturing
- Expert knowledge of cGMP and regulatory requirements
- Experience with Microsoft applications and quality documentation systems
- Pharmaceutical industry experience required
Required Skills
- Strong communication, leadership, and teamwork abilities
- Excellent organizational and time management skills
- Knowledge of quality systems, including change control, deviations, and CAPA processes
- Ability to manage multiple priorities in fast-paced environments
- Proficiency in SOP development, documentation, and reporting
Preferred Skills
Pay range and compensation package
None specified
Equal Opportunity Statement
None specified
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