Director, QA Operations

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

This is an exciting role in a rapidly growing contract manufacturing organization. As a Director – QA Operations, you will represent Quality Assurance and provide Quality oversight to a multi-product cell therapy manufacturing facility. This is a client facing role that requires strong verbal and written communication skills.

How You Will Make an Impact:

Represent Quality Assurance on the Site Leadership Team and Technical Transfer teams to onboard new clients to RoslinCT.

Partner with cross-functional stakeholders for continuous improvement activities, implementation of new procedures, training requirements, etc.

Lead Quality Culture initiatives and performance

Host client audits and inspection preparedness activities

Demonstrated leadership of continuous improvement initiatives and operational excellence tools and methodology

Partner with Quality Systems in developing GMP-related Quality Metrics and Key Performance Indicators (KPIs) to measure Quality performance

Manage the day-to-day activities of the QA Operations team to support product manufacture, testing and release.

Quality contact for facility modifications, routine shutdowns and re-certification of the facility

Demonstrated experience with complex deviations, root cause analysis techniques, OOS investigations and risk assessments

Self-motivated with sound judgement and problem-solving skills

Supervise direct reports including setting objectives, monitoring performance and conducting reviews

What You Will Bring:

Thorough knowledge of GMP regulations is required (FDA and EMA); direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus; direct interaction with EU Qualified Person (QP) is a plus

Experience supporting early development and all clinical phases through commercialization and lifecycle management

Proficiency in use of electronic QMS Software

Strong organizational skills with the ability to multi-task and prioritize

Excellent attention to detail, organizational and time management skills

Must have strong written and oral communication skills

Qualifications:

10+ years of experience in GMP Quality in biologics industry required with a minimum of 5-8 years of experience, coaching, mentoring and supervising direct reports

Experience with advanced therapeutic modalities such as cell therapy is desired

University degree in life sciences or related fields is required

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.

Full-time