Mantell Associates · 2 days ago
Senior Quality Assurance Specialist
California, United States
Full-time
Hybrid
Senior LevelMantell Associates is partnered with a fast-growing, innovation-driven CDMO specialising in drug product development, who is searching for an experienced Senior QA Specialist - Supplier Audits. This role is instrumental in strengthening supplier quality and compliance across a network of critical raw materials and component providers.
EducationPharmaceuticalStaffing Agency
Hiring Manager
Matt Askew
Responsibilities
Plan, execute, and lead supplier audits (on-site and remote) in accordance with cGMP, ISO standards, and internal procedures
Evaluate supplier quality systems, processes, corrective actions, and risk controls to ensure compliance and robust supply continuity
Prepare comprehensive audit reports, findings, and recommendations, and drive closure of audit observations with stakeholders
Support supplier qualification activities, including documentation review, risk assessments, and technical evaluations
Collaborate with Quality, Procurement, Regulatory, and Manufacturing teams to escalate supplier risks and implement mitigation strategies
Maintain audit schedules, quality intelligence, and supplier performance metrics to support continuous improvement
Serve as a subject matter expert on supplier quality expectations, training internal partners as needed
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Chemistry, or related discipline
Significant experience in supplier quality, audits, and quality systems within a pharmaceutical, biopharmaceutical, or CDMO environment
Strong knowledge of cGMP, ICH, regulatory expectations, and quality risk management principles
Demonstrated ability to lead supplier audits and effectively communicate findings to technical and operational stakeholders
Excellent analytical, report writing, and interpersonal skills with a proactive, solutions-oriented mindset
Ability to travel as required to support supplier audit activities (domestic and, occasionally, international)
Preferred
Advanced degree or quality certification (e.g., ASQ CQA)
Company
Mantell Associates
Mantell Associates is a headhunting firm providing staffing solutions for the medical and life science consulting sectors.
Founded in 2017
51-200 employees
Funding
Current Stage
Growth StageRecent News
Maryland Daily Record
2025-08-12
Company data provided by crunchbase