Manager of IT Quality Assurance - Kindeva Drug Delivery/Summit Biosciences

Summary:

Responsible for driving and executing the overall QA strategy that aligns with the wider IT strategy across all QA teams.  This includes new technologies, automated systems, eQMS, ERP system implementation/integration, and support of electronic Facilities & Engineering systems.  In this role, the candidate would ensure that drug development, registration, and commercialization activities, through the use of electronic systems, are compliant with all applicable regulatory requirements and guidelines.

Essential Duties:

• Design and execute the Quality Assurance strategy in close partnership with various departments.  Coordinate with IT, Manufacturing, QA, Development, Facilities & Engineering, and Validation to identify and prioritize key systems initiatives and ensure cohesive end-to-end quality assurance of all enterprise/software based/web-based solutions.
• Lead the IT QA group through a clearly defined process-driven methodology to ensure project goals, QA standards, and internal best practices are routinely followed.
• Partner with business and development teams to review business and technical requirements. 
• Participate in teams to develop comprehensive test strategies, plans, impact analysis, specifications, and test cases for effective assurance and testing functions.  May attend factory acceptance testing or site acceptance testing for equipment with automation.
• Partners with IT and QA for GxP IT supplier audits, review master service agreements, and quality agreements.
• Review and approve change controls, validation protocols, and operational procedures for new equipment or systems with automation, that require Web services, or batch-based integrations/implementations. 
• Perform user acceptance testing where applicable, communicate business risks and mitigation plans based on outcomes of testing.
• Contribute to and define best practices, processes, scorecards, KPIs, and tools for the QA organization ensuring overall productivity and quality is measured at all times and improved in line with targeted milestones.
• Assumes ownership of the QA Administrator role in electronic systems (where applicable), review routine updates/feature enhancements provided by SaaS vendors, and provide feedback to teams toward change control and required testing. 
• Review and approval of preventative maintenance (addition of new equipment and utilities, and routine PMs) from the Quality perspective.  Review and approval of validation protocols for new equipment and systems.
• Reviews new/draft batch records involving new production equipment, new lab equipment, and systems with automation.
• Reviews and approves calibration related documents and calibration procedures for new instruments.
• Partner with various departments to develop and deploy training for electronic systems, provide ongoing support after deployment, and assist with issue resolution.

Qualifications:

• BS in chemistry, biology, information technology, computer sciences or related field
• 8+ years GMP quality experience
• 3 years supervisory/management experience
• Experience required in managing software/application quality assurance at scale
• Proven track record in leading development of test automation strategy, tools, and frameworks
• Experience with ERP systems, electronic Quality Management systems, electronic preventative maintenance/corrective maintenance/calibration systems such as BMRAM
• 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 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