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Senior Quality Assurance Leader
2 months ago
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.