Job Summary:
The Director of Quality is responsible for developing, implementing, and maintain a cGMP Quality System to meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and customer expectations.
Supervisory Responsibilities:
- Oversee all Quality departments.
- Provide support to all Quality departments.
- Interview, hire, and train new staff.
- Provide constructive feedback and retraining as needed.
- Handles discipline of employees in accordance with company policy.
Duties/Responsibilities:
To establish the quality system.
- Establish the quality management system to describe how the firm complies CGMPs and operates to maintain a state of control.
- Keep current with good industry practices, and applicable to the mission of your operation.
To audit compliance to the quality system.
- Audit for compliance to policies and procedures.
- Report on the performance of the quality system that help
decision making for targeted actions.
To establish procedures and specifications.
- Ensure that procedures and specifications are appropriate and followed.
- Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.).
To establish manufacturing controls.
- Ensure that appropriate manufacturing in-process controls are implemented.
- Ensure in-process controls are performed during manufacturing operations and results are satisfactory.
To review and approve or reject all things cGMP related.
- Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents.
- Review and approve/reject reprocessing and rework procedures.
- Review and approve/reject production batch records and make the final decision to release a product lot into commerce.
To ensure investigation of nonconformance.
- Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes.
- Review and investigate consumer complaints.
To keep management informed.
- Report on product, process and system risks.
- Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure.
To describe responsibilities in writing.
- Have a complete and compliant procedure that describes responsibilities.
- Follow the procedure.
To remain independent.
- Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities.
- Be independent reviewer and approver with respect to manufacturing and process/product development units.
Required Skills/Abilities:
- · Excellent verbal and written communication skills in English.
- · Excellent management and teamwork skills.
- · Excellent organizational skills and attention to detail.
- · Excellent time management skills with a proven ability to meet deadlines.
- · Ability to function well in a high-paced and at times stressful environment.
- · Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company.
- · Understanding of quality systems including change control, deviations and CAPAs.
- · Ability to handle multiple tasks concurrently and complete them in a timely manner.
- · Strong written and verbal language skills to effectively read and write SOPs and related lab reports, and communicate with personnel at all levels in the organization.
Education and Experience
- · B.S. in Chemistry, Biology, or a related discipline.
- · Experience in computer software, such as Microsoft applications.
- · Expert knowledge of cGMP regulations.
- · Expert knowledge and understanding of FDA policies and regulations.
- · 10+ years of management experience in a pharmaceutical manufacturing setting.
- · Pharmaceutical experience required.
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Relocation assistance
- Vision insurance
Requirements
Quality: 10 years
FDA regulations: 5 years
cGMP Experience: 5 years
- WIlling to relocate to Gulfport, MS is required.
Benefits
Benefits:
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Relocation assistance
- Vision insurance
Skills Required
- B.S. in Chemistry, Biology, or a related discipline
- 10+ years of management experience in a pharmaceutical manufacturing setting
- Expert knowledge of cGMP regulations
- Expert knowledge and understanding of FDA policies and regulations
- Quality 10 years
- FDA regulations 5 years
- cGMP Experience 5 years
What We Do
Allen Spolden specializes in clinical research operations management and provides tailored workforce solutions for clinical research organizations, pharmaceutical, biotech, and healthcare sectors. They offer services in clinical research, data management, regulatory affairs, and talent acquisition.
