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Senior Quality Assurance Leader

2 months ago


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

Cellipont Bioservices is expanding, and we are in search of a Senior Quality Assurance Leader who is passionate about transforming scientific breakthroughs into therapeutic solutions. This role is pivotal in enhancing our commitment to quality and compliance.


Key Responsibilities

  • Lead strategic initiatives within the Quality Assurance department, driving operational excellence and fostering continuous improvement.
  • Implement phase-appropriate quality systems to ensure consistent compliance across all processes.
  • Oversee the maintenance of quality systems and standard operating procedures (SOPs) to meet regulatory compliance standards.
  • Establish and monitor key performance indicators to enhance quality compliance awareness and resource allocation.
  • Manage batch record reviews and lot disposition to ensure timely product releases in line with regulatory requirements.
  • Collaborate with various functional units, including Manufacturing and Quality Control, to address and resolve quality-related issues.
  • Develop and enforce procedures and policies that align with Good Manufacturing Practices (GMP) and overall compliance strategies.
  • Lead quality investigations and ensure the implementation of corrective and preventive action plans.
  • Act as the system owner for Client Audit, CAPA, and non-conformance management programs.
  • Coordinate and facilitate routine client audits, ensuring compliance risks are effectively managed.
  • Participate in the review of quality metrics, identifying adverse trends and implementing corrective measures.
  • Oversee staffing, training, and professional development within the Quality Assurance team.
  • Support facility expansion initiatives by coordinating quality assurance efforts.
  • Continuously evaluate quality systems for efficiency and compliance improvements.
  • Collaborate with senior management on client proposals, analyzing resource allocation and quality assurance costs.
  • Partner with leadership to align strategic priorities with organizational growth models.

Candidate Profile

  • Bachelor's or Master's degree in a Life Sciences discipline.
  • Over 10 years of relevant experience in the life sciences sector, particularly in biotechnology or pharmaceuticals, with a focus on Quality Assurance.
  • At least 8 years of direct management experience.
  • Comprehensive understanding of cGMP regulations and quality systems.
  • Proficient in electronic management systems and MS Office applications.
  • Experience with Federal government contracts is advantageous.
  • In-depth knowledge of biological manufacturing processes and industry best practices.
  • Ability to adapt to new manufacturing processes and changing priorities.
  • Exceptional communication and interpersonal skills.
  • Strong attention to detail and organizational skills.
  • Proven technical writing and editing capabilities.
  • Creative problem-solving and troubleshooting skills.
  • Demonstrated leadership abilities.

Benefits

  • Opportunities for career advancement within a growing team.
  • Defined career progression and annual performance evaluations.
  • Cross-functional exposure to various organizational areas.
  • Comprehensive benefits package tailored to health and wellness needs.
  • 401K with strong employer matching.
  • Tuition reimbursement programs.
  • Employee referral bonuses.
  • Flexible work schedules and increasing PTO based on tenure.
  • Experience in the innovative field of cell therapy.

Note: Cellipont Bioservices does not accept unsolicited resumes from agencies or search firms for this position.