Sr. Specialist Quality Systems & Compliance

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!

Responsibilities

• Manage the Quality System records process (Deviation, Change Control, Corrective Action and Preventive Action, Effectiveness Checks, Complaint Management, Recalls and Laboratory Investigations (including Out of Specifications) within Trackwise.
• Manage the Daily/Weekly Quality System Governance Boards and maintain associated Trackers.
• Support audit readiness, including co-hosting/participating in Regulatory Inspections and client audits.
• Support the compilation of responses for client/regulatory agencies’ audit findings.
• Support and/or manage the Internal Audit Program.
• Support the creation and management of client quality agreements.
• Prepare, review, approve/reject CGMP documents within the current electronic Document Management System.
• Support/conduct the required initial and continued training for quality systems and compliance.
• Perform regulatory gap assessment when a new regulation is released, or existing regulation is updated.
• Manage and gather Quality Metrics for Quality Management Review.
• Monitor quality metrics and trends and provide periodic updates to Senior Management.
• Manage the Quality Risk Management process.
• Support continuous improvement and operational excellence projects.
• Mentor junior Quality Specialists.
• Perform Quality Control data and audit trail review.
• Additional duties as assigned, including cross-training in other functional Quality areas (e.g., QA on the floor activities supporting client projects, including line clearance and room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing).

Requirements

• BS required; MS preferred in scientific/technical discipline.
• Minimum of 7 years of experience in managing Quality Systems in clinical and commercial pharmaceutical/biopharmaceutical manufacturing.
• Excellent working knowledge and experience with the practical implementation of FDA, EMA, and ICH regulations and guidelines.
• Experience in TrackWise, Pilgrim is preferable.
• Certification from American Society for Quality is preferable.
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy.
• Exceptional oral and written communication skills to all organization levels and clients.
• Strong organizational skills; able to prioritize and manage through complex processes/projects.
• Ability to define problems, collect data, and draw valid conclusions.
• Extensive experience with writing and managing investigations and risk assessments.
• Previous experience as an auditor for internal and vendor audits.
• Ability to be hands-on and detail-oriented.

Pay

The pay range for this position is $105,000-125,000 per year. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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.

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.