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 Senior Quality Compliance Specialist is responsible for ensuring the highest level of preparedness for all audits and inspections, driving continuous improvement, and minimizing risk. Utilizing a strong background in quality compliance, identify and address gaps while working collaboratively with other SMEs.

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:

• Foster a Quality Culture

• Lead and coordinate internal and external audits, including regulatory inspections (e.g., FDA, EMA, Health Canada) and customer audits.

• Develop audit plans and support audit preparation, execution, and corrective actions.

• Review and track audit findings, ensuring that corrective and preventive actions (CAPAs) are effectively implemented and monitored.

• Work collaboratively with other departments to author audit and inspection responses

• Develop, maintain, and enhance audit procedures to ensure comprehensive and effective auditing processes.

• Lead and support Quality Risk Management (QRM) activities, including risk assessments, risk mitigation, and ensuring appropriate action plans are in place to address identified risks.

• Drive the implementation of risk-based decision-making in compliance, ensuring that risk control measures are integrated into product lifecycle management.

• Identify areas for process improvements and provide actionable recommendations.

• Ensure timely completion of internal and external audits.

• Write and approve SOPs

• Manage and track KPIs

• Develop, improve, and monitor the Quality System

• Additional duties as assigned

QUALIFICATIONS:

• BS required; MS preferred in scientific/technical discipline

• 7+ years of experience in a GMP environment

• Strong knowledge of GMP, SOPs and quality system processes

• Excellent organizational skills and ability to review and update processes or procedures

• Proven experience in quality compliance, particularly in audits and inspections

• Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems. Previous experience in TrackWise, Smartsolve is preferable

• Certification from American Society for Quality on certified quality audit is a plus

• Experience in pharmaceutical or bio-pharmaceutical field

• Education or training in cell culture and gene therapy manufacturing environment is a plus

• Proficient in drafting and completing technical documents and presentations

• Expertise in document management processes and tracking metrics

• Quality systems demonstrated knowledge in areas such as Deviation, CAP A, EV, and Change Control system management practices/strategies

• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/600/820, ICH and EMA)

• Demonstrates knowledge and understanding of pharmaceutical manufacturing and quality assurance, aseptic and packaging processes, and product transfer

• Ability to develop and maintain positive, professional relations across all levels of the organization

COMPENSATION DATA

The pay range for this position is $105,000-$125,000 per year.

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.