Quality Assurance Director
ALLEN SPOLDEN, Gulfport, MS, United States
Job Description
Allen Spolden is actively seeking a Quality Assurance Director for a permanent (Direct Hire) opportunity.
Relocation assistance will be provided. Location:
Gulfport, MS (100% onsite is required.) Work Schedule:
M-F, flexible start Salary:
Dependent on experience. Job Summary: The Quality Assurance Director will play a crucial role in developing, implementing, and maintaining a compliant Good Manufacturing Practices (cGMP) Quality System. This system must meet the requirements of 21CFR210, 21CFR211, regulatory agencies, and customer expectations. Supervisory Responsibilities: Oversee all Quality departments. Provide support across all Quality departments. Interview, hire, and train new staff. Deliver constructive feedback and retrain as needed. Handle employee discipline according to company policies. Duties/Responsibilities: Establishing the Quality System:
Develop a quality management system demonstrating compliance with cGMP regulations and operational control. Stay updated on industry practices relevant to our operational mission.
Audit Compliance:
Conduct audits to ensure adherence to established policies and procedures. Report on quality system performance to inform decision-making.
Procedure and Specification Development:
Ensure all procedures and specifications are suitable and adhered to. Maintain oversight of procedures and specifications for contracted services.
Manufacturing Controls:
Implement appropriate in-process controls during manufacturing operations. Confirm satisfactory performance of in-process controls.
Document Review:
Review and approve/reject documents that outline work instructions and requirements. Make ultimate decisions on product lot releases.
Nonconformance Investigation:
Ensure investigations are conducted to eliminate root causes of discrepancies and errors. Review consumer complaints thoroughly.
Management Communication:
Report on product, process, and system risks to management. Update on outcomes of regulatory inspections and ensure thorough responses.
Responsibility Documentation:
Create comprehensive procedures detailing responsibilities. Adhere strictly to these procedures.
Independence Assurance:
Avoid any conflicts of interest in regulatory responsibilities. Act as an independent reviewer and approver regarding manufacturing and development functions.
Required Skills/Abilities: Excellent verbal and written communication skills in English. Strong management and teamwork skills. Outstanding organizational capabilities and attention to detail. Effective time management with a proven ability to meet deadlines. Ability to thrive in a fast-paced and sometimes stressful environment. In-depth understanding of Standard Operating Procedures and current Good Manufacturing Practices. Comprehensive grasp of quality systems, including change control, deviations, and CAPAs. Proficient in handling multiple tasks concurrently. Strong writing skills for creating SOPs, lab reports, and communicating across all organizational levels. Education and Experience: B.S. in Chemistry, Biology, or a related discipline. Experience with Microsoft applications. Expert knowledge of cGMP regulations. Proficient understanding of FDA policies and regulations. 10+ years of management experience in a pharmaceutical manufacturing environment. Pharmaceutical experience is essential. Benefits: 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 Willingness to relocate to Gulfport, MS is required.
Relocation assistance will be provided. Location:
Gulfport, MS (100% onsite is required.) Work Schedule:
M-F, flexible start Salary:
Dependent on experience. Job Summary: The Quality Assurance Director will play a crucial role in developing, implementing, and maintaining a compliant Good Manufacturing Practices (cGMP) Quality System. This system must meet the requirements of 21CFR210, 21CFR211, regulatory agencies, and customer expectations. Supervisory Responsibilities: Oversee all Quality departments. Provide support across all Quality departments. Interview, hire, and train new staff. Deliver constructive feedback and retrain as needed. Handle employee discipline according to company policies. Duties/Responsibilities: Establishing the Quality System:
Develop a quality management system demonstrating compliance with cGMP regulations and operational control. Stay updated on industry practices relevant to our operational mission.
Audit Compliance:
Conduct audits to ensure adherence to established policies and procedures. Report on quality system performance to inform decision-making.
Procedure and Specification Development:
Ensure all procedures and specifications are suitable and adhered to. Maintain oversight of procedures and specifications for contracted services.
Manufacturing Controls:
Implement appropriate in-process controls during manufacturing operations. Confirm satisfactory performance of in-process controls.
Document Review:
Review and approve/reject documents that outline work instructions and requirements. Make ultimate decisions on product lot releases.
Nonconformance Investigation:
Ensure investigations are conducted to eliminate root causes of discrepancies and errors. Review consumer complaints thoroughly.
Management Communication:
Report on product, process, and system risks to management. Update on outcomes of regulatory inspections and ensure thorough responses.
Responsibility Documentation:
Create comprehensive procedures detailing responsibilities. Adhere strictly to these procedures.
Independence Assurance:
Avoid any conflicts of interest in regulatory responsibilities. Act as an independent reviewer and approver regarding manufacturing and development functions.
Required Skills/Abilities: Excellent verbal and written communication skills in English. Strong management and teamwork skills. Outstanding organizational capabilities and attention to detail. Effective time management with a proven ability to meet deadlines. Ability to thrive in a fast-paced and sometimes stressful environment. In-depth understanding of Standard Operating Procedures and current Good Manufacturing Practices. Comprehensive grasp of quality systems, including change control, deviations, and CAPAs. Proficient in handling multiple tasks concurrently. Strong writing skills for creating SOPs, lab reports, and communicating across all organizational levels. Education and Experience: B.S. in Chemistry, Biology, or a related discipline. Experience with Microsoft applications. Expert knowledge of cGMP regulations. Proficient understanding of FDA policies and regulations. 10+ years of management experience in a pharmaceutical manufacturing environment. Pharmaceutical experience is essential. Benefits: 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 Willingness to relocate to Gulfport, MS is required.