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.