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 Associate Director of Quality Systems will be responsible for leading general Quality and compliance oversight of support functions, Quality Systems, Standardized Training Practices, and Document Control for a viral vector manufacturing site supporting cell and gene therapy clients. This role supports the site quality vision as the organization scales rapidly under private equity ownership.

• Oversight – working with site leadership, this person will lead a team of Quality Associates that are dedicated to executing and advising on Quality initiatives regarding Audits and Inspections as well as Functional Support Operations.

• Systems – partner with global Quality stakeholders for development, implementation, and continuous improvement of Quality Management Systems (paper and electronic) which include but are not limited to Document Control, Deviations, CAPA, Change Control, and Quality Management Review (QMR).

• Training – oversee training program lead that partners with Site and leadership SMEs to develop effective training and to ensure that all required training meets company and GMP standards.  

• Document Control – oversee the teams responsible for: review and approval of Quality Management System (QMS) tracking and trending reports, scheduling and adherence of Quality Management System governance boards, supplying raw data and metrics to the various governance boards, ensuring compliance to Quality Management Systems across all functions at the site.

• Supplier Quality – oversee team and process that ensures vendors and suppliers are assessed for compliance with applicable regulatory requirements.

The person filling this role will be responsible for the leadership, development, and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cell and gene therapy production. Our core values — Reliable, Outcome Driven, Scalable, Excellent — are the foundation for how we operate and deliver value to our clients and, ultimately, to patients.

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.

Key Responsibilities and Duties:

• Support the implementation of electronic Quality systems consistent with company policy and process.

• Management and Improvement of current Quality Systems as defined by site Quality Plans.

• Evaluation of the Quality needs of incoming clients by assessing the prospective clients’ Quality Systems, while developing a plan with key milestones to integrate their process into the Quality Systems.

• Maintain knowledge base of policies and procedures concerning company Quality Systems and operational philosophies.

• Development of Quality staff members at varying levels of experience.

• Build cross-functional relationships with relevant internal and external departments necessary to ensure sustained delivery of Quality performance and KPIs.

• Establish and drive the use of accurate and actionable metrics for clearly identifying areas of risk, performance to commitments, effectiveness, and timeliness related to Quality Systems, General Quality Oversight, and Training.

• Ensure the effective functioning of CAPA system/process to eliminate the causes of detected discrepancies (reactive) and preventive actions are in place to eliminate the causes of potential discrepancies of other undesirable situations (proactive).

• Ensure internal standards and procedures for Computer System Validation/Data Integrity remain effective and all systems are compliant.

• Direct the audit program, including developing a standard process and implementing audits of manufacturing, quality systems, suppliers, vendors and warehouses.

• Keep current and strategic with regulatory requirements, proposals, and best practices via constant surveillance of governmental publications.

• Serve as a site point of contact for regulatory agencies.

• Oversee a Supplier Quality Controls program, including governance and oversight, to ensure compliance and consistency in areas of investigation, effectiveness, timeliness, quality, and thoroughness of content.

• Take appropriate steps to reduce waste and losses in Quality System processes and improve efficiency in ways of working.

• Preparation of Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning and allocation and manage within approved budgets while building best in class quality processes and systems at site.

• Ensure completion and adherence to training of subordinates in area of oversight as per the job requirement.

• Provide leadership to and ensure necessary Quality oversight to areas within span of control.

• Effectively model, demonstrate and live 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.

• Lead, coach and mentor individuals from all parts of the organization with varying levels of experience. Be a valued resource for the site in all matters related to quality and compliance.

• Champion our guiding values — Reliable, Outcome Driven, Scalable, Excellent — through consistent actions and leadership integrity.

• Perform all other related duties as assigned.

Qualifications:

• BS/BA required; MS in a scientific or technical discipline preferred

• Minimum 8 years of leadership experience in Quality, Business/Data Analytics, IT, or related field.

• Experience supporting customer audits and Regulatory inspections from multiple governments and agencies.

• Demonstrated knowledge of current GMP regulatory interpretations of QMS requirements, current industry best practices in biologics or cell and gene therapy manufacturing preferred.

• Previous experience in the deployment and use of Electronic Quality Systems for document control, deviation management, CAPA and change control.

• Ability to multi-task effectively.

• Strong analytical, problem-solving, and project management skills.

• Experience managing staff, developing future quality leaders, and building an organizational culture is required.

• Working knowledge of Root Cause Analysis, measuring Data Integrity KPIs, data analysis.

• Experience with the following software packages/categories: QMS, DMS, LIMS, MES, Power BI, Smartsheet, and Microsoft Office 360.

• ISO Lead Auditor training is desirable.

• Certified Quality Engineer (ASQ) is desirable.

• Six Sigma Green or Black Belt Certification is preferred.

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

• Ability to manage 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 managements systems and other information management systems

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.