The Director of Quality Assurance has overall responsibility for providing leadership and direction for all Quality Assurance programs and for ensuring compliance with all relevant FDA regulations and guidelines as they pertain to marketed drug products. This includes overseeing the preparation and approval of master batch documents, SOPs, specifications and protocols. Also responsible for the release of raw materials, packaging components, in-process and finished products. In addition, duties include coordination of GMP training and internal and vendor compliance audits, oversight of validation projects, facility / process and equipment change control, investigation of procedural deviations, nonconformances, customer complaints and environmental anomalies. Primary liaison for client and regulatory audits. The Director of Quality Assurance has responsibility for the company’s Quality Management System; and for the assurance of drug quality, strength, identity, and purity throughout the manufacture, processing, packing, testing, and holding of the drug product.

Duties and Responsibilities:

The responsibilities of the Director of Quality Assurance include, but are not limited to:

• Manage and supervise a quality assurance (QA) team, including hiring, training, education and coaching.
• Direct and manage the Quality Management System and all other aspects of the Quality Assurance Department on a day-to-day basis for the assurance of drug quality, strength, identity, and purity throughout the manufacture, processing, packing, testing, and holding of the drug product.
• Establish and maintain all standard operating procedures as they relate to the Quality.
• Develop and manage programs to improve quality and ensure that quality goals align with business objectives and regulations.
• Responsible for the establishment of inspection standards to be used by the Quality Assurance Department.
• Responsible for administering the auditing program to assure that all operations are periodically audited for compliance to cGMP requirements.
• Responsible for establishing and administering a cGMP Training Program for the overall company.
• Direct and manage the Change Control Committee ensuring that the Document Control Procedures are applied to all proposed changes generated at the lab facility, including, but not limited to the review and approval of any changes to the facility, equipment, product and manufacturing changes to ensure compliance with applicable regulations.
• Review and approval of all procedures related to manufacturing, production, testing and maintenance. Review of associated records.
• Ensuring that controls are implemented and completed satisfactorily during manufacturing operations.
• Reviewing production records and investigating any unexplained discrepancies.
• Participate in various meetings to represent the Quality Assurance Department.
• Prepare, manage and monitor the annual budget for the Quality Assurance Department.
• Responsible for hiring and terminating personnel in the Quality Assurance Department.
• Daily operations of the Quality Assurance Department.

Qualification Guides

Essential Knowledge/Experience:

• B.S. in Science Curriculum (Chemistry, Biology, Pharmacy) or a related science.
• A minimum of 5+ years’ managerial experience in a related field, preferably in the pharmaceutical industry in a quality assurance environment.
• Experience in all aspects of Quality Assurance functions with in-depth knowledge of cGMP's.
• Strong communication skills (written and verbal)
• Ability to problem solve
• Retain information as strictly confidential.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person