Senior Specialist, Quality Assurance

About the role

The Senior Specialist, Quality Assurance (BDQR) provides quality oversight and technical support for analytical and process development activities supporting large‑molecule programs. The role ensures compliance with cGMP, worldwide regulations, and company requirements while partnering with cross‑functional stakeholders.

Key responsibilities

• Provide GMP/GxP quality assurance for manufacturing and testing operations, including batch documentation review and disposition.
• Identify compliance risks in the biologics clinical space, escalate issues, and support compliant execution in fast‑paced environments.
• Partner with stakeholders to enable compliant start‑up and execution of GMP activities and maintain quality‑by‑design practices.
• Oversee quality events such as deviations, change controls, CAPA, and audits, and contribute to training and audit readiness.
• Review and approve analytical and manufacturing documents for regulatory filings, clinical supply, and technology transfer.

Required profile

• Minimum 5 years of experience in pharmaceutical/biotechnology quality or manufacturing (BS) or 3+ years with an advanced degree.
• Strong knowledge of cGMP, health‑authority regulations, and GMP continuum in R&D.
• Demonstrated project management, communication, and problem‑solving abilities.

Required skills

• Audits Compliance
• CAPA Management
• Deviation Management
• GMP Auditing
• Manufacturing Processes
• Operational Compliance
• Operational Quality
• Quality Assurance Processes
• Quality Assurance Systems
• Quality Risk Management
• SAP (mentioned as a technical tool)