Building expert teams to advance science.

About the Role 

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent!

The Director QA Operations will report to the Sr. Director or Vice President of Quality (Memphis), and will be responsible for the development, implementation, and improvement of quality operations and regulatory interactions with all manner of national and international regulatory authorities for any client or local concerns relating to the Memphis Manufacturing Operations.  This position interacts regularly with key clients.  This position is responsible for overseeing all quality operations functions, including lot disposition, deviation and CAPA disposition, quality on the floor activities, hosting client and regulatory audits, including responses and continuous improvements. This position will provide the appropriate leadership and strategic direction to operate and maintain a regulatory compliance position in support of existing and new cellular therapy production. Serves as a site host during regulatory inspections and regularly communicates with all local, national, and international regulatory agencies.   This position will also oversee timely batch lot disposition, timely investigation, and CAPA related to deviations.  This position will also oversee the development and presentation of all quality Management Review metrics and site risk assessment.  

Why Rose BioSolutions 

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.

• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.

• Opportunities to grow your technical expertise and take ownership of your work.

• Close interaction with leadership and clients, enabling real influence on project outcomes.

 ESSENTIAL DUTIES AND RESPONSIBILITIES:  

• Conceptualize, create and develop all Quality Operations strategy and tactics for the Memphis Manufacturing Operations, in collaboration with other Quality Assurance groups and Manufacturing.

• Develop and oversee the quality on the floor operations, including timely identification of deviations and corrective actions, timely lot disposition, line clearances and in-place continuous audits.   

• Advise the Head of Quality of necessary regulatory changes and updates to regulatory and compliance approaches. 

• Develop and execute training and Management briefings at any technical or compliance level required on updates and regulatory requirements for Cell and Gene Therapy manufacturing and controls.

• Manage the implementation, maintenance, and improvement of all lot disposition functions.

• Regularly communicate with clients and participate in the Client quality reviews and other steering committees as required.

• Act as the acting Head of Quality as needed or assigned.

• Develop metrics and run the Quality Management Review process for clients and Memphis Operations.  

• Review and comment on any CMC regulatory filings for clients.

• Review/ approve the Firm’s “drug master file.”

• Review/ approve/ update the Firm’s “site master file.”

• Perform any client label approvals.

• Coordinate and publish any correspondence with Regulatory Agencies.

• Represent the Quality department during regulatory inspections, client audits, and various cross-functional meetings, as needed.

• Participate in the Company GMP Training Programs, including new employee orientation and periodic GMP retraining and selected topics.

• Oversee the Company's quality management system deployment and monitoring, including client metrics, effective deviation investigation, and effective CAPA.

• Oversee the Visual Inspection Program and Packaging Inspection Manufacturing

• Oversee the Incoming Receipt and Inspection program for components and raw materials

• Oversee the writing update of most GMP Company documents, including batch record development and deployment, label generation, work orders, validation protocols/ reports, and standard operating procedure updates.  

• Demonstrate an employee-focused leadership style that prioritizes compliance, respectful and professional cross-departmental collaboration, accountability, and the well-being, personal, and career development of each employee.

• Perform all other related duties as assigned.

QUALIFICATIONS:

• Minimum BS/BA Life Sciences or related field. An advanced degree in the life sciences is preferred, but not essential, based on experience

• Minimum 10 years of experience in a biologics, pharmaceutical, medical device, or related industry.  15 years' experience is preferred

• Previous experience in Cell and Gene Therapy is desirable, but not a require per say, if other experience in the regulated life sciences 

• Ability to maintain a high degree of accuracy and attention to detail.

• Ability to handle a fast-paced, multi-tasking environment and prioritize effectively.

• Demonstrated project management skills

• Demonstrated management and collaboration skills

• Outstanding verbal and written communication skills. 

• Complete competency with electronic document management systems and other information management systems

• Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.

Physical Demands

• Ability to sit frequently throughout the workday (approximately 2.5–5.5 hours per day).

• Ability to stand frequently throughout the workday (approximately 2.5–5.5 hours per day).

• Ability to walk frequently throughout the workday (approximately 2.5–5.5 hours per day).

• Ability to occasionally lift and/or carry up to 50 pounds.

• Lifting and/or carrying more than 50 pounds is not required.

• Occasional reaching above shoulder level may be required.

• Occasional bending and stooping may be required.

• Occasional use of hands for pushing and pulling activities is required.

• Occasional use of hands for fine manipulation, including handling small objects, operating equipment, and computer-related tasks.

• Driving is not required for this position.

• Work is performed in a moderate-stress environment.

 Why Join Us?

• Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.

• Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.

• Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.

Perks & Benefits

• Competitive base salary with performance-based bonus opportunities.

• Comprehensive health, dental, and vision insurance.

• 401(k) with company contribution.

• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.