Director Clinical Operations Quality

BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson's disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

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 committed to scientific excellence, operational rigor, and the highest standards of ethics and compliance. The company fosters an inclusive, collaborative environment where innovation, diversity, and patient-centricity drive every decision.

Responsibilities:

Operational Quality Documentation:

• Lead and/or actively manage the development, enhancement, review, and implementation of controlled documents (e.g., SOPs, Work Instructions, Templates) in Clinical Operations
• Develop and assist in implementing Clinical Operations Department SOP and training curriculums
• Trial Master File (TMF): Develop, implement and evolve TMF standards and tools.
• Provide operational leadership, planning, oversight, and delivery of an Inspection Ready Trial Master File (TMF) for BlueRock clinical trials.
• Collaborate with Clinical Operations team members of implementation of TMF standards and tools for clinical studies including supporting collaboration with CRO's and/or collaborators in alignment with BlueRock standards.
• Compliance & Process Improvement: Provide guidance and compliance consulting and support to Clinical Operations staff and other GCP-related departments, as applicable, based on interpretation of current regulations to ensure the best practice including risk-based management.
• Support the design, implementation and continuous improvement of the CRO operating model for outsourced studies.
• Champion clinical compliance for BlueRock sponsored studies.
• Establish and maintain strong collaboration with internal and external Quality Assurance stakeholders.
• Support audit readiness and risk mitigation initiatives.
• Contribute to the advancement or lead department and organizational process improvement initiatives. (e.g clinical compliance and inspection readiness)
• Leadership: In collaboration with Clinical Operations senior leadership members, foster a culture of collaboration, compliance, continuous improvement, and operational excellence across the enterprise.

Minimum Requirements:

• Bachelor's degree in life sciences or related field
• 10+ years in Clinical Operations in a pharma/biotech or CRO environment at least half of which includes working directly on trial documentation or Clinical Quality.
• A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.).
• In-depth knowledge of and ability to interpret and apply GCP EU, FDA and ICH regulations and guidelines and 21 CFR Part 11. Related experience in GLP and/or GVP Quality Assurance is preferred.
• Track record driving initiatives related to clinical compliance and inspection readiness. continuous improvement
• Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities.
• Ability to identify quality issues/discrepancies, and effectively and proactively manage, and resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills.
• Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities.
• Specific experience in cell and/or gene therapy settings and experience with Veeva systems is a plus.

Working Environment:

• Full-time position
• Location: Cambridge, MA (Remote or hybrid work arrangements available)

BlueRock Therapeutics Company Culture Highlights:

• Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023
• Winner of Comparably's Award for Best Company for Diversity 2022
• Winner of Comparably's Award for Best Company for Women 2022
• Winner of Comparably's Award for Best CEO 2022
• BlueRock 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.

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.