QA Lead, Quality Systems (Cell Therapy)(W)

Cellipont Bioservices; The Woodlands (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) with strong employer match

Tuition reimbursement

Flexible work schedules

Employee referral bonuses

Job summary

Cellipont Bioservices is seeking a QA Lead for Quality Systems to enhance its Quality Management System (QMS) in The Woodlands, Texas. The role demands a strong candidate with over 8 years of experience in the biopharmaceutical or regulated pharmaceutical domain, ideally with a background in Quality Assurance.

The position offers robust benefits including career growth opportunities, 401(k) matching, and tuition reimbursement, all designed for unique health and wellness needs.

Qualifications

• Minimum of 8 years’ experience in the biopharmaceutical industry.
• At least 6 years in a Quality Assurance position focused on QMS.
• Strong background in GMP processes related to biological manufacturing.

Responsibilities

• Ensure compliance with Good Manufacturing Practices (GMP) for QMS.
• Lead audits and ensure actions for compliance are initiated.
• Support FDA and EMA regulatory inspections.

Skills

Quality Assurance

Good Manufacturing Practices (GMP)

Regulatory Compliance

Risk Management

Cross-Functional Collaboration

Education

BS in Life Sciences

Tools

Smartsheet

Excel

Job description

Job Summary

Cellipont Bioservices is growing, and we are looking for a QA Lead, Quality Systems who believes in the potential of bridging client’s discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.

The QA Lead, Quality Systems will be a key position for the Quality Management System (QMS), ensuring compliance with Good Manufacturing Practices (GMP) and all applicable internal and external requirements. This role encompasses the supervision of QMS including, but not limited to: deviation, change control, CAPA, effectiveness checks, internal audits, supplier quality, and client audits. The individual must demonstrate strong cross‑functional collaboration and leadership skills.

The Role

• The key point of contact for the QMS including deviations, CAPAs, effectiveness checks, and change controls.
• Participate in the Change Control Review Board by identifying gaps, risks, procedural requirements, and regulatory requirements and ensuring actions are initiated to achieve compliance and mitigate risks.
• Review and/or approve deviations, CAPAs, effectiveness checks, and change controls.
• Generate monthly, quarterly, and annual compliance metrics for the site.
• Perform internal audits of manufacturing and support areas.
• Participate and/or lead client on‑site audits.
• Support regulatory inspections (e.g., FDA, EMA).
• Support supplier qualification program by performing audits, drafting reports, and tracking responses as needed.
• Identify and communicate any quality issues and propose solutions based on quality risk management principles and risk mitigation.
• Participate in and/or lead site quality and process improvement initiatives.
• Guide personnel (indirectly and directly) involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.
• Provide training for new or revised quality processes.
• Generate and/or revise GMP documents.
• Support GMP departments in performing and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs).
• Stay current with changes to Good Manufacturing Practices, including FDA, EU, ICH, ISPE, and other regulatory bodies relevant to Cellipont Bioservices activities.
• Other duties as assigned.

The Candidate

• BS. in a Life Sciences discipline with a minimum of 8 years’ experience within the biopharmaceutical or regulated pharmaceutical industry (previous CDMO experience is a plus) and at least 6 years in a Quality Assurance position focused on QMS.
• Strong technical and quality background related to biological manufacturing (preferably Cell Therapy).
• Strong familiarity with GMP processes within the pharmaceutical industry.
• Ability to apply basic scientific and regulatory principles.
• Self‑starter capable of producing results in a fast‑paced environment to meet client deadlines under minimal supervision.
• Strong knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs.
• Provides technical solutions to complex problems that require ingenuity and creativity.
• Ability to work in a team setting and independently under minimal supervision.
• Familiarity with electronic systems, including developing and producing reports using Smartsheet and Excel.
• Excellent oral and written communication skills with all levels of personnel and regulatory inspectors.

Position Benefits

• Opportunities for career growth within an expanding team.
• Defined career path and annual performance review & feedback process.
• Cross‑functional exposure to other areas within the organization.
• Robust benefit package designed for unique Health & Wellness needs, including coverage for pets.
• 401(k) with strong employer match.
• Tuition reimbursement.
• Employee referral bonuses.
• Flexible work schedules and PTO that increases by one day each year, plus paid holidays.
• Gain experience in the cutting‑edge cell therapy space.