The position is responsible for promoting a culture of quality best practice across all research and manufacturing activities. In addition, the QA Director is responsible for the development and operation of an effective quality management system to protect the integrity of MonoSol Rx’s product. The position will sponsor technical excellence throughout the operation and formulate quality strategy to assist the senior management team in managing and controlling key business risks.
Lead and develop a team responsible for the implementation and oversight of Quality Systems and practices to assure compliance with 21 CFR Part 210 + 211 throughout MSRx.
Steer the site compliance effort as well as onsite FDA cGMP and PAI inspections, including all CAPA implementation and responses.
Provide strategic oversight in the development, implementation, and maintenance of SOPs for the site which includes but not limited to the manufacturing/testing and release activities at MonoSol Rx.
Guide the team by ensuring that training and documentation integrate all quality and compliance requirements into the day to day manufacturing processes through all levels of quality including the quality floor support functions.
Coordinate and provide oversight and document approval relating to the activities coordinated and executed by the Engineering team such as: Calibration and Facilities Validation; ensuring the execution of protocols to carry out equipment, facility and process related validation activities.
Ensure the maintenance, review, and approval of all Master Documentation such as: Batch Records, Specifications, SOPs and test methods.
Assure all events, deviations, Complaints, APRs, OOS investigations, CAPAs and Change Controls are processed in a timely manner and are accurately and effectively executed and approved.
Provide Risk Assessments for any critical issues to alert the organization of any risks.
Coordinate the efforts to plan, promote, and organize training activities related to MonoSol Rx quality procedures, SOP’s, government regulations and regulatory compliance.
Ensure all supplier activities meet the specified requirements prior to use.
Conduct weekly meeting with site management to assure all activities are on target for approval.
Provide site metrics on a weekly and monthly basis as needed.
Drive the process of continuous improvement throughout MSRx.
Minimum B.S. degree in Chemistry, Biochemistry or related science field. Advanced degree preferred.
12 -15 years experience in Pharmaceutical or biotechnology industry
At least 10 years of direct managerial responsibility in Quality Assurance.
Demonstrated ability to work well with regulatory bodies (FDA, DEA, etc)
Strong knowledge of quality assurance principles, especially relating to quality control systems.
Experience in interacting with several departments and leading cross functional teams and projects.
Demonstrated knowledge of cGMPs and other regulatory requirements for the manufacture, testing, and release of pharmaceutical products.
Ability to effectively deal and negotiate with customers, representatives of various government auditing agencies.
Excellent written, oral, communication, leadership and organizational skills.
Please visit our website @ www.Monosolrx.com