This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Specialist, Quality Assurance based in the United States.
This role offers the opportunity to provide critical Quality Assurance leadership within a fast-paced, highly regulated biotechnology environment. You will support new product introduction and routine cGMP operations while helping ensure that manufacturing activities meet rigorous quality and regulatory standards. Working closely with Manufacturing, Quality Control, Engineering, Facilities, Supply Chain, Regulatory Affairs, and Process Sciences, you will provide practical quality guidance across the organization. You will play a key role in reviewing and approving GMP documentation, managing quality events, and supporting product disposition. The position also offers the opportunity to strengthen quality systems, improve operational processes, and contribute to a culture of continuous improvement. This is an impactful role for an experienced QA professional who enjoys working hands-on in dynamic manufacturing environments.
Accountabilities
- Provide independent Quality Assurance oversight and direction during site start-up activities and routine cGMP operations, ensuring work is performed in accordance with approved procedures, quality standards, and regulatory requirements.
- Partner cross-functionally with Manufacturing, Supply Chain, MSAT, Facilities, Validation, Quality Control, and other teams to identify compliance risks and provide practical, timely quality guidance.
- Provide quality expertise for the implementation and maintenance of material control processes, including reviewing and approving material specifications and supporting material disposition.
- Review and approve Master Batch Records, SOPs, work instructions, product specifications, and other controlled GMP documentation.
- Review and approve Deviations, CAPAs, Change Controls, and other quality-system records while ensuring appropriate investigation and resolution.
- Support the design and implementation of batch record review and product disposition processes.
- Provide real-time Quality-on-the-floor support and oversight within manufacturing and laboratory environments.
- Develop, monitor, and trend quality-system performance indicators and metrics to identify opportunities for improvement.
- Contribute to the continuous improvement of site quality systems, processes, and operational practices.
- Communicate quality expectations clearly, challenge decisions appropriately, and maintain effective partnerships across technical and business functions.
Requirements
- Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or another relevant life sciences or technical discipline, or an equivalent combination of education, training, and experience.
- At least 8 years of professional experience within an FDA-regulated industry, with strong knowledge of cGMP requirements and quality systems.
- Demonstrated ability to independently assess quality and compliance risks, make sound decisions, and provide effective quality support in dynamic manufacturing environments.
- Strong knowledge of Good Documentation Practices and data integrity principles, with the ability to interpret and apply regulatory requirements using a practical, risk-based approach.
- Strong technical writing, investigation, analytical, and problem-solving skills, combined with excellent verbal and written communication abilities.
- Proven ability to collaborate effectively across functions while appropriately challenging decisions and maintaining productive professional relationships.
- Experience supporting viral-vector, cell-therapy, gene-therapy, biologics, or aseptic manufacturing operations is preferred.
- Experience with batch record review, product disposition, cGMP audits, or regulatory inspections is highly desirable.
- Knowledge of FDA regulations, EU GMP requirements, ICH guidelines, and applicable industry standards is an advantage.
- Ability to work primarily onsite and support operations in laboratories, manufacturing areas, and clean-room environments as required.
- Ability to gown aseptically, remain standing or gowned for extended periods, handle chemicals and biological materials, and regularly lift 10–20 lbs., with occasional lifting of up to 50 lbs.
- Willingness to work occasional nights or weekends when operational needs require it.
Benefits
- Annual salary range of $105,060–$129,780.
- Competitive medical, dental, and vision insurance plans.
- 401(k) retirement plan through Fidelity with a 100% company match on the first 4% of employee contributions.
- Generous paid time off.
- Employee commuter benefits.
- Cell phone stipend.
- Opportunities to contribute to innovative biotechnology and advanced therapeutic development.
- Collaborative work environment with opportunities for professional growth and continuous learning.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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