Summary:

Responsible for the management of the company’s quality assurance and laboratory functions with the goal of ensuring that drug development, registration, and commercialization activities are compliant with all applicable regulatory requirements and guidelines.

Essential Duties:

• Lead the development, implementation and management of GMP quality and compliance systems and policies, including the timely development of QA processes and procedures
• Oversee the implementation of SOPs, specifications, and protocols necessary for the laboratory.
• Manage the day-to-day activities of the QA group and the quality systems with respect to the writing, review and approval of GMP documentation and business practices
• Oversee the management of the laboratory in compliance with FDA, OSHA and DEA regulations
• Lead efforts to ensure the site operates in compliance with internal policies, health authority/regulatory regulations, and evolving expectations
• Author or review, and compile regulatory documents in CTD format for submissions.
• Establish the quality plan, strategy, and objectives for the site
• Inspire transformative thinking and motivate employees to deliver benchmark performance
• Develop and Chair the site quality management review board to continuously improve quality and compliance performance by reviewing KPIs and sharing best practices, lessons learned, evolving regulations/expectations and inspection findings
• Support product robustness efforts and other initiatives to improve product quality and compliance
• Develop and monitor quality performance metrics, for example incident reports and QC schedule attainment
• Assure compliance with all company SOPs, directives, policies, testing requirements and regulatory agency guidelines and expectations
• Lead and foster an environment of continuous improvement in all QA, QC, and compliance functions/systems at the site
• Contribute to and support overall site goals and initiatives
• Develop and share best practices and collaborate throughout the organization to implement continuous quality, efficiency and cost-savings initiatives
• Serve as residentcurrent good manufacturing practices (cGMP) QA expertin support of document control, change control, and validation
• Direct and manage the Change Management Program
• Support plant management groups on new products and changes to products, processes, and services to achieve a consistent approach to quality
• Direct quality and compliance process improvements and goals using current regulations and demonstrated best practices
• Hire, train and develop staff and conduct Performance Reviews to assure highly effective, team-oriented contributors to company’s success
• Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance
• Provide information to customers on quality systems and quality improvement plans.
• Interact with Clients and Partners to ensure customer satisfaction
• Provide QA input to technology transfers
• Provide QA oversight and follow-up on non-product specific incidents related to utilities, facilities and equipment
• Participate in all plant activities to ensure cGMP compliant manufacturing and regulatory inspection readiness
• Develop and manage the PAI readiness plan
• Lead internal and external GMP audits, including the timely preparation of audit reports and responses
• Lead vendor auditing and qualification program
• Perform review of regulatory submission documents
• Advise senior management on findings and recommendations related to quality
• Perform Manufacturing Batch review and disposition
• Maintain current knowledge of regulatory developments
• Oversee out-of-specification investigations and batch deviations along with implementation of respective corrective and preventive actions
• Oversee the budgets for the laboratory
• Provide oversight of DEA controlled substance inventories, SOPs, and reports. Assure compliance with DEA controlled substance regulations including registrations, reporting, and documentation
• Other duties as assigned

• BS in chemistry, biology or related field
• 10 years experience in quality management
• Extensive technical experience in analysis and development of pharmaceuticals
• Excellent technical writing, project management, and organizational skills
• Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
• Familiar with the necessary components of facility qualification and validation activities
• Extensive knowledge of cGMP regulations and ICH guidelines
• Flexible, adaptable, self-motivated and able to work well independently and across teams
• Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
• Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team
• Demonstrated knowledge of modern analytical techniques, including HPLC
• Experience in developing specifications for raw materials and finished products
• Qualified to work with controlled substances
• Demonstrated ability to make and act on decisions while balancing speed, quality, and risk
• Significant knowledge in drug product manufacturing, quality assurance, validation, quality control, regulatory affairs, and technology transfer
• Ability to think clearly and decisively; remain calm under adverse conditions
• Demonstrated ability to work independently or in groups in a complex, changing environment
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments
• Ability to provide innovative, compliant ideas, or alternatives that create value, including seeking new information and external insights