Quality Assurance Specialist- Suppler Quality
Listed on 2026-08-21
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering -
Supply Chain/Logistics
Regulatory Compliance Specialist
Job Title
Manage a portfolio of critical raw materials, laboratory consumables, manufacturing materials, and specialized scientific supplies supporting research, development, quality, and production operations.
Collaborate with stakeholders across Manufacturing, Quality Assurance, Supply Chain, Engineering, Technical Operations, and Scientific teams to ensure uninterrupted material availability and operational continuity.
Assess supplier capabilities, quality systems, technical competencies, service levels, and overall performance to support business objectives and regulatory expectations.
Support sourcing and procurement activities for GMP and non-GMP materials, services, and technologies utilized throughout regulated operations.
Monitor supplier performance, inventory trends, material consumption, and supply risks to identify opportunities for cost optimization, efficiency improvements, and mitigation strategies.
Participate in supplier business reviews and cross-functional meetings focused on quality, delivery performance, capacity planning, risk management, and continuous improvement initiatives.
Partner with Quality and Technical Operations teams on supplier qualification activities, risk assessments, compliance evaluations, and corrective action follow-up efforts.
Conduct market assessments and supplier evaluations to identify alternative sources, emerging technologies, and innovative solutions that strengthen supply reliability and operational performance.
Track sourcing initiatives and provide updates regarding project milestones, supplier performance metrics, implementation timelines, and value-driven outcomes.
Support resolution of material discrepancies, supplier non-conformances, returns, and supply-related challenges while ensuring appropriate documentation and communication.
Develop and maintain strong supplier partnerships that support scientific, manufacturing, and commercial objectives.
Contribute to strategic initiatives focused on operational excellence, supply chain resilience, supplier development, and process standardization.
Qualifications & ExperienceExperience supporting sourcing, supplier performance management, and supply continuity within pharmaceutical, biotechnology, life sciences, CDMO, or other regulated manufacturing environments.
Proven ability to investigate supply disruptions, supplier-related challenges, and operational constraints while supporting root cause investigations and sustainable corrective actions.
Strong analytical skills with experience evaluating supplier, operational, quality, and inventory data to identify trends and drive informed decision-making.
Demonstrated ability to influence stakeholders and collaborate across cross-functional teams in a fast-paced and highly regulated environment.
Excellent organizational skills with the ability to manage competing priorities, complex projects, and critical timelines.
Continuous improvement mindset with a track record of identifying opportunities that improve efficiency, reduce risk, and enhance operational performance.
Experience evaluating cost drivers, business impacts, and value-based sourcing decisions.
Working knowledge of regulatory requirements, quality management systems, supplier compliance practices, and GMP manufacturing environments.
Understanding of supplier lifecycle management, risk assessment methodologies, and external partner collaboration.
Strong communication and relationship-management skills with the ability to work effectively across Quality, Manufacturing, Supply Chain, Engineering, Technical Operations, and Research functions.
Experience supporting business discussions related to supplier performance, service delivery, quality expectations, and operational objectives.
Ability to balance scientific, operational, quality, and financial considerations when making recommendations and supporting strategic decisions.
Required QualificationsBachelor's degree in Biotechnology, Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, Supply Chain Management, Business Administration, or a related discipline. Advanced degree or MBA preferred.
8+ years of experience within the pharmaceutical, biotechnology, life sciences, or highly regulated manufacturing industry.
Experience supporting cGMP operations, quality systems, change control processes, and supplier management activities.
Proficiency with SAP ERP systems and Microsoft Office applications, including Excel, Word, and Outlook.
Strong interpersonal and cross-functional collaboration skills.
Experience supporting supplier evaluations, cost analysis, and strategic sourcing initiatives.
Ability to analyze data, assess risks, and make recommendations supporting supply continuity and operational goals.
Proven ability to manage multiple priorities in a dynamic environment.
Additional Role InformationPrimary materials supported may include active pharmaceutical ingredients (APIs), specialty chemicals, resins, advanced manufacturing materials, and other regulated raw…
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