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

Job Description

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 Check, Internal Audits, Supplier Quality, and Client Audits. This role will also require the individual to demonstrate a strong ability to work cross-functionally and possess strong leadership skills.

The Role

• The key point of contact for the QMS including Deviations, CAPAs, Effectiveness Checks, and Change Controls.
• Participate in Change Control Review Board by identifying gaps, risks, procedural requirements, and regulatory requirements and ensure actions are initiated to ensure 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 leads client on-site audits.
• Support regulatory (i.e. FDA, EMA) inspections.
• Supports 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.
• Guides 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.
• Generation and/or revise GMP documents.
• Supports 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, and be able to interpret, changes to current Good Manufacturing Practices, including FDA, EU, and other regulatory bodies (relevant to Cellipont Bioservices activities) and guidance bodies including ICH, ISPE, etc.
• Other duties as assigned.

The Candidate

• BS. in a Life Sciences discipline with a minimum 8 years of experience within the biopharmaceutical or regulated pharmaceutical industry (previous CDMO experience is a plus) and at least 6 years of experience in a Quality Assurance position with focus 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 with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
• Strong knowledge base with 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 which require the regular use of ingenuity and creativity
• Able to work in a team setting and independently under minimum supervision
• Familiarity with electronic systems, including developing and producing reports using Smartsheet and Excel
• Requires the ability to produce quality results in a fast-paced environment to meet client deadlines
• Able to communicate effectively orally and written 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 your furry family members
• 401K strong employer match
• Tuition Reimbursement
• Employee Referral Bonuses
• Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
• Gain experience in the cutting-edge cell therapy space

"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"

Notice to Agency and Search Firm Representatives

Cellipont Bioservices does not accept unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.