Director QA Operations

The Role

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.

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

Pay and Benefits

The pay range for this position is $184,400-$203,800 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Company Culture

Rose BioSolutions offers:

• 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
• 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

About Rose BioSolutions

Rose BioSolutions provides seamless program continuity from early research through commercial supply across the US and EU, eliminating handoffs that delay progress. With decades of expertise, including plasmid DNA manufacturing since 1992, 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!

Benefits

• 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.
• 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.

Schedule

Not specified

Skills

• 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.

Contact Information

A few questions and your resume. We'll take it from there.