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Company | Summit Biosciences Inc. |
Address | Lexington, KY, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-08-07 |
Posted at | 9 months ago |
Summary:
- Lead and foster an environment of continuous improvement in all functions/systems at the site
- Provide oversight of DEA controlled substance inventories, SOPs, and reports. Assure compliance with DEA controlled substance regulations including registrations, reporting, and documentation
- Oversee out-of-specification investigations and batch deviations along with implementation of respective corrective and preventive actions
- Other duties as assigned
- Provide QA input to technology transfers
- Lead efforts to ensure the site operates in compliance with internal policies, health authority/regulatory regulations, and evolving expectations
- Advise senior management on findings and recommendations related to quality
- Develop and share best practices and collaborate throughout the organization to implement continuous quality, efficiency and cost-savings initiatives
- Provide information to customers on quality systems and quality improvement plans.
- Perform Manufacturing Batch review and disposition
- Establish the quality plan, strategy, and objectives for the site
- 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.
- Contribute to and support overall site goals and initiatives
- 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
- Direct quality and compliance process improvements and goals using current regulations and demonstrated best practices
- Lead vendor auditing and qualification program
- Assure compliance with all company SOPs, directives, policies, testing requirements and regulatory agency guidelines and expectations
- Serve as resident current good manufacturing practices (cGMP) QA expert in support of document control, change control, and validation
- Develop and monitor quality performance metrics.
- Support plant management groups on new products and changes to products, processes, and services to achieve a consistent approach to quality
- Inspire transformative thinking and motivate employees to deliver benchmark performance
- Participate in all plant activities to ensure cGMP compliant manufacturing and regulatory inspection readiness
- Interact with Clients and Partners to ensure customer satisfaction
- Lead the development, implementation and management of GMP quality and compliance systems and policies, including the timely development of QA processes and procedures.
- Provide QA oversight and follow-up on non-product specific incidents related to utilities, facilities and equipment
- Lead internal and external GMP audits, including the timely preparation of audit reports and responses
- Maintain current knowledge of regulatory developments
- Hire, train and develop staff and conduct Performance Reviews to assure highly effective, team-oriented contributors to company’s success
- Demonstrated ability to work independently or in groups in a complex, changing environment
- Ability to provide innovative, compliant ideas, or alternatives that create value, including seeking new information and external insights
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments
- Experience in developing specifications for raw materials and finished products
- Demonstrated ability to make and act on decisions while balancing speed, quality, and risk
- Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team
- 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
- Flexible, adaptable, self-motivated and able to work well independently and across teams
- Qualified to work with controlled substances
- Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
- Extensive knowledge of cGMP regulations and ICH guidelines
- 10 years GMP quality experience
- 2 years supervisory/management experience
- Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
- Extensive technical experience in analysis and development of pharmaceuticals
- Excellent technical writing, project management, and organizational skills
- BS in chemistry, biology or related field
- Familiar with the necessary components of facility qualification and validation activities
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