Director of Quality

2 weeks ago

Gulfport, United States Allen Spolden Full time
Job Description
Allen Spolden is actively recruiting for a Director of Quality. This is a perm (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 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.
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
  • 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

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