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BlueRock is seeking an Associate Director, QA (QMS). This is an outstanding opportunity for a talented individual to join the organization and help drive the continued evolution of an enterprise wide QMS designed to enable this cutting edge organization to realize and bring life-changing cell therapies to the clinic. BlueRock Therapeutics is dedicated to bringing a new class of medicines to patients which requires the knowledge & strength of established quality best practices along with the ability to adapt those best practices to novel and cutting edge drug development, including research, product and clinical development. At BlueRock we utilized a principles based approach to our quality system that is anchored in Data Integrity, Scientific Integrity, Patient safety and Product Integrity as our focus to deliver reliable and actionable results. Collaboration with a highly-motivated, world-class team of scientists, engineers, IT professionals as well as quality & compliance professionals dedicated to enabling our teams to deliver on bringing life changing medicines to patients, promises an exciting and engaging work environment for a motivated, self-starting candidates, that can strategically design, build, implement and adapt processes and approaches as the organization evolves.
The AD will be a core driver of our QA processes, through continuously improving, monitoring and supporting QA owned process and SOPs, developing training material and leading cross functional engagements. The AD will have a leadership role focused on ensuring accuracy, reliability and security of data throughout the entire drug development and manufacturing lifecycle. This is a great opportunity to have a major impact to enable reliable and successful business outcomes through a fit for purpose quality & compliance approach.
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%)
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