Quality Assurance Operations Lead

1 week ago

Spring Hills, Texas, United States Cellipont Bioservices Full time
Job Overview

Position Summary

Cellipont Bioservices is expanding, and we are seeking a Quality Assurance Operations Lead who is passionate about connecting client innovations to therapeutic solutions and is eager to redefine industry standards while elevating both Cellipont and its clients.

The Quality Assurance Operations Lead will serve as the primary liaison for the client project team, nurturing relationships and ensuring project objectives are met. This role entails developing comprehensive project timelines, pinpointing key milestones, and overseeing all activities necessary for the successful completion of client projects related to QA lot release.

In this capacity, the Quality Assurance Operations Lead will supervise batch record evaluations and ensure that lot release outcomes are client-centric, results-driven, and compliant with all relevant internal and external standards. This individual will monitor project progress, address challenges, or escalate issues as needed to guarantee timely delivery of all client projects, while effectively managing risk mitigation strategies and stakeholder communications. Additionally, this role will provide QA support for new product launches at the facility, requiring a strong ability to collaborate across functions and exhibit exceptional leadership capabilities.

Key Responsibilities

  • Provide QA oversight and support for client projects, collaborating closely with QA Management to ensure compliance with GMP operations for cellular therapy manufacturing.
  • Act as the QA representative in client meetings and interactions.
  • Work collaboratively with Project Management, AD/PD, Supply Chain, Manufacturing, F&E, and Quality Control to execute client project activities within established timelines.
  • Identify compliance risks and propose remediation strategies to management, leading the implementation of solutions.
  • Guide the successful execution of major programs and may take on a project leadership role.
  • Review and approve master batch records, executed batch records in real-time, and supporting documentation for accuracy and compliance.
  • Serve as the first point of contact for all manufacturing quality concerns, collaborating with clients to achieve resolutions.
  • Assist GMP departments in documenting deviations and conducting failure investigations, including root cause analysis and implementing effective corrective and preventive actions (CAPAs).
  • Lead the On-the-Floor program and perform Area Clearances, which involve gowning into a Class B environment.
  • Provide training on standard operational procedures and support compliance-critical initiatives.
  • Support and/or lead client on-site audits and participate in technical visits.
  • Assist with regulatory inspections (e.g., FDA, EMA).
  • Maintain systems for tracking various GMP manufacturing support activities.
  • Generate and/or revise SOP documents in accordance with cGMPs.
  • Help manage Quality programs and systems to ensure adherence to Quality requirements and provide guidance on GMP-related matters.
  • Stay informed about updates to Good Manufacturing Practices, including FDA, EU, and other relevant regulatory bodies.

Candidate Qualifications

  • Master's degree in a Life Sciences discipline with a minimum of 8 years of experience in the biopharmaceutical or regulated pharmaceutical sector (CDMO experience is advantageous) and at least 6 years in Quality Assurance.
  • Ability to apply scientific and regulatory principles to resolve operational and routine quality challenges.
  • Self-motivated with a proven track record of delivering results in a fast-paced environment with minimal supervision.
  • Extensive knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs.
  • Strong technical and quality expertise related to biological manufacturing, preferably in Cell Therapy.
  • Ability to provide innovative solutions to complex problems requiring creativity and ingenuity.
  • Quick learner of new and innovative manufacturing processes supporting diverse clients.
  • Capable of working both independently and collaboratively within a team environment.
  • Familiarity with electronic systems, including report generation using Smartsheet and Excel.
  • Proficient in producing quality results in a dynamic environment to meet client expectations.
  • Knowledge of pharmaceutical regulations pertaining to biologics is preferred.
  • Adept at interpreting new and existing global regulations.
  • Effective communicator, both orally and in writing, with all levels of personnel and regulatory inspectors.

Position Benefits

  • Opportunities for professional advancement within a growing team.
  • Defined career trajectory and annual performance evaluation process.
  • Exposure to various functional areas within the organization.
  • Comprehensive benefits package tailored to unique health and wellness needs, including coverage for pets.
  • 401K with a strong employer match.
  • Tuition reimbursement programs.
  • Employee referral bonuses.
  • Flexible work schedules and paid time off, increasing one PTO day each year, along with paid holidays.
  • Experience in the forefront of the cell therapy industry.

At Cellipont Bioservices, we value candidates who possess a genuine desire to serve. Our collaborative approach ensures you receive the mentorship necessary for a fulfilling career.

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