Quality Assurance At-the-Source Specialist, Cell Therapy

Regulatory Toolkit; Rockville (MD); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Incentives program

Equity-based awards

Health, dental, and vision coverage

Qualified retirement programs

Paid time off

Job summary

Regulatory Jobs in United States (Rockville, MD) seeks an independent Quality Assurance leader for cell therapy manufacturing. This four-day-per-week, Wed–Sat role partners with Manufacturing to apply risk-based quality judgment and resolve issues within established frameworks.

You will coach teams, support real-time decisions, and ensure regulatory readiness through disciplined follow-through. Qualifications include multi-path QA experience with degrees from BS to HS levels, strong cGMP

Qualifications

• 5+ years of QA experience with a BS in science, engineering or related field.
• 9+ years QA experience with an Associates degree.
• 13+ years QA experience with a High School Diploma.
• Proven ability to work in a fast-paced environment across multiple technical functions.
• Strong knowledge of cGMPs.
• Ability to make decisions under pressure balancing patient safety, compliance and supply.

Responsibilities

• Provide real-time QA leadership in manufacturing operations.
• Support manufacturing unit operations from a QA perspective and resolve events in real-time.
• Assess routine and moderately complex QA situations and determine actions within standards.
• Collaborate across functions to clarify requirements and remove barriers.
• Identify emerging risks and communicate implications with recommended actions.
• Lead problem-solving and improvement activities with evidence-based decisions.
• Coach colleagues on quality thinking, data integrity, and right-first-time behaviors.
• Contribute quality judgment to shift handoffs, readiness discussions, and cross-functional forums.
• Manage multiple priorities independently and maintain follow-through in a fast-paced patient-focused environment.
• Support inspection readiness and represent Quality within delegated authority.
• Work a four-day shift schedule (Wed-Sat) with potential off-hours/holidays for operations.

Skills

cGMP knowledge

Decision making under pressure

Cross-functional collaboration

Education

B.S. degree in Science, Engineering or related technical field

Associates degree

High School Diploma

Job description

Job Profile Description

Provides independent, visible Quality Assurance leadership at the source of cell therapy manufacturing. This is a shift-based role scheduled for four days per week, Wednesday through Saturday. Partners with Manufacturing and supporting functions to apply risk-based quality judgment, resolve issues within established frameworks, and support reliable, compliant execution. Operates independently across qualified routine and moderately complex situations, influences cross-functional decisions, and strengthens quality culture through practical coaching, clear communication, and disciplined follow-through. Specific quality-system responsibilities and approval authorities are defined through applicable procedures, qualifications, and delegated authority.

This is a shift-based role scheduled four days per week, Wednesday through Saturday.

Typical Accountabilities

• Maintain a consistent Quality presence in manufacturing areas and provide real-time, practical guidance that supports safe, compliant, and reliable execution.
• Support manufacturing unit operations from a Quality Assurance perspective and assist to resolve manufacturing events and/or quality events in real-time
• Independently assess routine and moderately complex quality situations, integrate available facts and risk considerations, and determine appropriate action or escalation within established standards.
• Partner across functions to clarify requirements, align decisions, remove barriers, and sustain appropriate Quality independence.
• Recognize emerging risks, recurring issues, and performance gaps; communicate implications and recommend proportionate actions.
• Lead defined problem-solving and improvement activities, ensuring decisions are evidence-based, clearly documented, and carried through to effective resolution.
• Coach colleagues on quality thinking, disciplined execution, data integrity, contamination control, and right-first-time behaviors.
• Contribute quality judgment to operational meetings, shift handoffs, readiness discussions, and cross-functional decision forums.
• Manage multiple priorities independently, communicate changes in risk or urgency, and maintain reliable follow-through in a fast-paced patient-focused environment.
• Support inspection readiness and represent Quality confidently within the scope of training, experience, and delegated authority.
• Work a shift-based schedule of four days per week, Wednesday through Saturday, and support occasional off-hours or holidays as needed for manufacturing operations and patient commitments.
• The role may require additional responsibilities as necessary.

Qualifications and Skills

QAATSSpecialistRequired Education and Experience:

• 5+ years applicablequalityexperience with B.S. degree in Science,Engineeringor related technical field
• 9+ years applicable withAssociatesdegree
• 13+ years applicable with High School Diploma
• Proven ability to work in a fast-paced environment across multiple technical functions
• Strong knowledge ofcGMPs
• Demonstrated ability to make decisions under pressure that balance patient safety,complianceand supply

Preferred Experience:

• Autologous cell therapy manufacturing or quality experience
• Working knowledge of international Cell TherapyGxPregulatory frameworks,regulationsand guidance

The annual base pay for this position ranges from $79,890 - $119,835. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

21-Oct-2026

Closing Date

03-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.