Quality Control Project Manager

Job Description

Job Description

WHO WE ARE

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives.

Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values : Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect.

We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance.

Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

We are seeking a highly skilled and detail-oriented Quality Control Project Manager to oversee our quality control operations.

This role will be responsible for managing schedules, leading projects, maintaining quality systems, overseeing testing processes, ensuring compliance with regulations, and processing documentation for QC.

The ideal candidate will have strong organizational skills, a deep understanding of quality control processes, and the ability to work collaboratively across departments and in a regulated industry.

How You Will Make an Impact :

Schedule Management :

o Develop and manage quality control schedules to ensure timely completion of testing and inspections.

o Coordinate with production and other departments to align schedules with quality control requirements.

Project Management :

o Lead and oversee quality control projects, ensuring that objectives are met within the specified timelines and budgets.

o Implement process improvements and innovations to enhance quality control efficiency.

o Implement Lean Lab principles and Operational Excellence standards.

Quality Systems :

o Complete QC quality systems on-time.

o Ensure all quality systems are compliant with industry standards and regulatory requirements.

o Provide QC Metrics / KPI

Testing :

o Review of QC Data

o Ensure accurate and reliable testing results and address any issues identified during testing.

Compliance and Regulations :

o Perform Risk Assessments for QC

o Monitor and ensure compliance with relevant regulations and industry standards.

o Knowledgeable on Annex 1 and Aseptic Processing Requirements

o Knowledgeable on Cell and Gene therapy requirements.

o Stay current with regulatory changes and implement necessary updates to policies and procedures.

Document Processing :

o Develop, maintain, and manage quality control documentation, including procedures, reports, and records.

o Ensure QC documentation is accurate, complete, and readily accessible for audits and reviews.

Monitoring and Reporting :

o Monitor quality metrics and performance indicators to identify trends and areas for improvement.

o Prepare and present quality control reports to management, highlighting key findings and recommendations.

Team Leadership :

o Provide guidance, training and support to the QC team as needed.

o Foster a culture of continuous improvement and quality excellence within the team.

Other duties as assigned.

What You Will Bring :

• Strong knowledge of quality control methodologies, testing procedures, and regulatory requirements.
• Excellent organizational and time management skills, with the ability to manage multiple priorities effectively.
• Strong analytical skills and attention to detail.
• Strong risk management skills
• Strong project management skills (Tools e.g smart sheets, Microsoft Project, Excel)
• Strong Operational Excellence Skills and Lean Lab principles
• Effective communication and interpersonal skills, with the ability to work collaboratively across departments.

Qualifications :

• Bachelor’s degree in a Science, Quality Management, Engineering, or a related field (or equivalent experience).
• PMP Certification preferable
• 5+ years of experience in quality control, with a proven track record in managing quality systems and projects.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized.

We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.