Senior Manager, Quality Assurance

Summary:

Responsible for the management of the company’s Quality Assurance functions to ensure 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 processes and policies, including the timely development of QA processes and procedures.
• Manage the day-to-day activities of the QA group with respect to the writing, review and approval of GMP documentation and business practices.
• Lead efforts to ensure the site operates in compliance with internal policies, health authority/regulatory regulations, and evolving expectations.  Interact with teams and lead continuous improvement projects, partner with Operations to ensure on time delivery of quality product.
• 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
• Develop and monitor quality performance metrics.
• 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 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 resident current good manufacturing practices (cGMP) QA expert in support of document control, change control, and validation
• 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
• 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
• Lead internal and external GMP audits, including the timely preparation of audit reports and responses
• Lead vendor auditing and qualification program
• 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
• 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

Qualifications:

• BS in chemistry, biology or related field
• 10+ years GMP quality experience
• 5 years supervisory/management experience
• 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
• 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

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