Associate Director, Quality Assurance Computer Systems Validation

Company: Acceleron Pharma
Location: Cambridge
Posted on: May 6, 2021

Job Description:

What's in it for you?. As the AD, Quality Assurance Computer Systems Validation, you will be responsible for quality oversight of all enterprise computer systems validation activities and computer applications associated with equipment and instruments. In this position, you will ensure compliance with applicable regulations in support of GxP compliant programs, cGMP manufacturing and CMC activities. Reporting to the Director of Quality Systems, you will drive critical processes, initiatives, and strategy for the QS department. What will you do?: Provide quality oversight and guidance of validation and qualification activities for enterprise computer systems and computer applications associated with equipment and instruments. Assist with the development of system requirements and specifications to ensure requirements are testable and regulatory requirements are met. Author or review/approve validation documentation including Validation Plans, Protocols, Traceability Matrix and Validation Summary Reports. Assess impact of platform changes for SaaS/Cloud applications and ensure ongoing compliance. Assess legacy systems for Data Integrity and formulate risk-based remediation plans with system owners and IT. Maintain Computer System Validation master list and manage and carry out periodic reviews. Manage projects in a cross functional environment, driving quality compliance and continuous improvement. Present project status reports to management as well as project teams. Work closely with IT to help develop and maintain the IT Quality Roadmap. Serve as Subject Matter Expert in the assessment and execution of deviations, corrective and preventive actions, and change controls. Assess the risk/criticality of quality issues involving computer systems and offer solutions and influence team thinking. Develop compliant CSV programs and procedures and actively advance the GxP knowledge base external to Quality including knowledge of industry best practices & global regulations. Support Vendor Audits and Supplier approval process where applicable with respect to computer systems. Represent Quality Systems as the QA CSV process owner in support of external regulatory, customer and third-party audits. Participate in internal audits as needed to support GxP activities. What are we looking for?: Well rounded CSV QA professional that is forward thinking, innovative, and remains current with industry trends. Well versed in FDA/MHRA/EU/ICH regulations and guidelines, and GAMP and USP AIQ methodologies. Strong understanding of CSV requirements for SaaS/Cloud applications. Strong understanding of Data Integrity requirements. Ability to apply risk-based thinking to tailor QA CSV consultation when assessing complex IT projects and determining CSV requirements. Demonstrated ability to manage projects, including prioritizing, planning, and delegating work to team members with ease; ability to communicate details to the team, the broader organization, and management as well as effectively gaining support and alignment. Project management certification a plus. Demonstrated history of sound, risk-based decision making internally and externally while paying close attention to detail. Excellent time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines. Influential and inspirational communicator with a demonstrated talent to drive quality discussions within the functional area, leadership, and across multiple departments. Ability to guide other's decision-making processes through healthy debate, mentoring, and drawing on industry/past experiences. CSV audit experience, including the development of CSV audit risk assessment tools, audit deliverables, and auditing skills. Ability to defend QA CSV policies, procedures, and decisions during internal process audits and inspections. Minimum of a four-year technical degree or equivalent education and work experience. Minimum of ten+ years' experience in pharmaceutical, biotech or related health-care industry.

Keywords: Acceleron Pharma, Cambridge , Associate Director, Quality Assurance Computer Systems Validation, IT / Software / Systems , Cambridge, Massachusetts