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Director, QA (QMS)

Employer
BlueRock Therapeutics
Location
Cambridge, Massachusetts
Start date
Nov 26, 2023

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Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown
Who is BlueRock?
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
What Are We Doing?
Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.
BlueRock is seeking a Senior Director, QA (QMS). This is an outstanding opportunity for a talented individual to lead the organization in 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. Additionally, the BlueRock QMS will be in support of Corporate Compliance and enterprise-wide training with an eye toward integrated quality and compliance management for the organization. This is not a role for which a cookie cutter/lift and shift mindset will fit, but rather where the incumbent can bring their expertise to build an outcomes-based quality infrastructure that fully enables the business and is able to smoothly adapt as the company matures, while delivering the highest degree of quality along the development continuum unique to the BlueRock technology and programs. Collaboration with a highly-motivated, world-class team of scientists, engineers, 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 Senior Director, QA will be a core driver of our QMS Strategy & Culture, through building and supporting a business-driven SOP and Learning program that achieves ownership of quality throughout our organization while educating the overall organization on risk-based approaches. The Senior Director, QA will also be responsible for electronic systems that support this process and partnering across our QA team in the support of connected and integrated solutions for our QA specific processes. The Quality System applies to the development, production and testing of cell therapies and medical devices under current Good Manufacturing Practices (cGMP) as well as preclinical (GLP), clinical activities (GCP), and compliance as well as support a broader GVP ecosystem through our parent company Bayer at the enterprise level. 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:
  • Serve as the functional process owner for all eQMS modules, working with the System Owner (IT) and Strategic Process Owner (Sr. Dir Quality Systems and External Quality) to maintain, continuously improve, and measure the effectiveness/health of the existing eQMS system and processes.
  • Design and implement new, as well as redesign and improve existing business processes as needed in support of Corporate, GLP, GCP and GMP operations.
  • Serve as the lead on development of programs to drive a risk-based and outcomes focused Quality Management System, supporting compatibility and integration of quality processes driven core principles, Data Integrity, Scientific Integrity, Patient safety and Product Integrity
  • Support the development of Governance related processes (e.g. quality polices, manuals, etc.), documentation, including metrics, dashboards, readouts in support of Quality Oversight, including an overall picture of the health of BlueRock's overall Quality management System in collaboration with the SVP, Quality Assurance
  • Grow & lead a team of quality professionals responsible for managing our process related to documentation and training and providing high levels of support for the enterprise as it relates to achieving documentation and training deliverables.
  • Support and foster collaborations with our Bayer colleagues as well as identify optimal areas of leverage to supplement the BlueRock quality ecosystem.
  • 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 or relevant scientific or engineering discipline
  • Minimum of 10+ years of experience in a quality role, preferably implementing and overseeing QMS within a broader quality organization for a life sciences organization supporting development programs (biotechnology, cell & gene therapy)
  • Minimum 10 years in a personnel managing role with demonstrated ability to mentor and develop staff and achieve goals through empowering teams.
  • Previous experience with analytics for use in managing quality issues enabling a risk-based approach
  • Experience with implementation of electronic quality management systems is desired, Veeva experience 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 (less than 15%) 
  • #LI-AL1
    BlueRock Therapeutics Company Culture HighlightsWinner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023Winner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.
    Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeuticsFollow us on Linkedin: https://www.linkedin.com/company/bluerocktx/
    Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace.  Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

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