Senior Specialist, Quality Assurance

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.
As a Senior QA Specialist you will play a pivotal role in ensuring quality at External CxOs who manufacture, test, store, package and/or label investigational cell and gene therapy products.
Responsibilities:

• Lead cGMP QA compliance activities at external CxOs for all relevant operations including activities related to raw material testing, gmp manufacturing, QC testing, release and stability of investigational cell and gene therapy products, packaging/labeling activities clinical supply
• Oversee, develop and/or execute BlueRocks Supplier Qualification program.
• Oversee and/or execute internal and external audit programs ensuring compliance with regulatory requirements and industry standards
• Participate as a QA representative at CMC project meetings
• From a QA perspective lead complex external OOS investigations, manufacturing investigations, change controls and implementation of CAPAs at external CxOs and internally when applicable
• Oversee quality aspects for commissioning, qualification and validation activities for equipment, batch record review, lot disposition, material release, deviation handling and quality event processes at external CxOs.
• Understanding of quality control methods, method qualification and method validation activities.

Minimum Requirements:

• Seeking a highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity
• Experience in Cell & Gene Therapy or Sterile Large Molecule Biologics highly preferred
• Experience with managing and conducting supplier qualification activities, internal and external audits
• Ability to and no restrictions for travel, at times internationally. 30%
• Skills with influencing and negotiating with stakeholders of various levels is highly desirable
• Life Sciences based Bachelor’s or advanced degree and minimum 7 years industry experience in pharma, biopharma, biotech with demonstrated knowledge of relevant cGMP regulations

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.
Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics
Follow 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.