Associate Director Quality Assurance (QA Process and Data Integrity)

Responsibilities:

• Create, manage and present, metrics, KPIs and dashboards intended to monitory and report on the overall picture of health of BlueRock's Quality Management System.  Perform in-depth data analysis to identify gaps, compliance concerns and recommend/implement improvements.
• Oversee and monitor the health of QA centrally owned GxP QMS processes (i.e. Issue Management, Lab Investigations, Change Control Management, CAPA Management, Supplier Quality, Audits) and own existing boards/review committees (i.e. Change Control Review Board, Tech Ops Quality Metrics Review).  Perform in-depth trend analysis of Quality Events and Root Causes, etc. to implement continuous improvements to the GxP QMS processes and SOPs. Create and deliver training content to the business for these GxP QMS Processes.
• As needed work cross functionally with TechOps (i.e QA Operations, QC, Manufacturing, Facilities) to triage and steer Quality Event activities to help ensure timely and effective resolution of Quality Events.
• Serve as the quality owner for the Data Integrity program at BlueRock.  Partner with IT and company wide functional areas to remediate (as needed), implement and maintain data integrity compliance activities across the end to end product lifecycle and various departments in alignment with relevant regulatory and corporate compliance regulations and guidelines.  Additionally serve as the lead QA representative for other non-Data Integrity related IT GxP activities such as GXP software validation lifecycle management and spreadsheet validation.
• Influence and guide in a collaborative fashion, across all aspects of the quality organization partnering with peers to enable quality processes within their space as well as establishing supportive partnership across the organization where appropriate
• Other duties as assigned

Minimum Requirements:

• Minimum of a Bachelor’s degree in Biology/Chemistry/Biochemistry or relevant scientific or engineering discipline
• Minimum of 8+ years of experience in a quality role, preferably overseeing QMS and/or data integrity programs within a broader quality organization for a life sciences organization supporting development programs (biotechnology, cell & gene therapy)
• Strong understanding of data integrity and experience with developing and implementing a comprehensive data integrity program is preferred
• Strong understanding of Change Control, Issue (Deviation) Management, OOS Investigations, Root Cause Analysis and CAPA implementation is preferred
• Previous experience with analytics for use in managing quality issues enabling a risk-based approach
• Experience with electronic quality management systems is desired, Veeva experience highly desirable and preferred.
• Must demonstrate strategic thinking, excellent organizational skills and be able to drive project teams forward while having a willingness to do hands on work to achieve goals
• Must be adaptable, flexible and able to work under high pressure and fast moving environment,
• Demonstrates calmness and decisiveness under pressure, with the ability to bring others along
• Strong technical writing skills (procedures, policies) with working knowledge of MS office programs, such as Word, Excel, SharePoint, and Adobe Acrobat professional are required
• Must be self-motivated with the demonstrated ability to work effectively with people from multiple departments, ensure deadlines are met, and manage multiple, potentially changing, priorities.
• Proven ability to identify and communicate effectively the problem statement for complex, multi-faceted issues
• Ability to travel if needed (~15%)