Summary of the position:
The QA Operations Sr. Manager will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.
The QA Operations Sr. Manager provides quality leadership and oversight across site operations, including materials, manufacturing, warehouse activities, quality interfaces, and product release. This role partners closely with cross?functional leaders to ensure robust processes, effective risk management, and consistent delivery of compliant, high?quality products. As a member of the Site Quality Leadership Team, the role drives a strong quality culture, supports continuous improvement, and translates regulatory expectations into practical, sustainable operational practices.
Essential Functions & Responsibilities:
Quality Oversight of Site Operations
Provide independent QA oversight and partnership across all operational activities, including incoming materials, warehouse, manufacturing, QC, and product disposition.
Ensure operational processes are designed and executed in compliance with GMP, ALCOA+ data integrity principles, and internal quality standards.
Partner with operational leaders to ensure processes are robust, capable of right-first-time execution, and support operational decision-making.
Ensure timely escalation of significant quality risks to site leadership and the Head of Quality.
Apply quality risk management principles (ICH Q9) in all operational decision-making.
Quality Culture & Operational Excellence
Act as a catalyst for a strong quality culture, providing guidance and coaching to operational teams.
Ensure QA presence in operations through Manufacturing QA and other QA Operations teams.
Translate regulatory expectations into practical, meaningful practices.
Promote proactive identification of risks, operational issues, and improvement opportunities.
Support teams in analyzing situations, addressing root causes, and implementing sustainable improvements.
Drive continuous improvement initiatives to enhance process robustness and operational performance.
Oversight of Quality Events and Investigations
Provide oversight for quality events impacting operations, including exceptions, non?conformances, and OOS results.
Drive timely, scientifically sound investigations focused on root cause and effective, sustainable corrective and preventive actions.
Responsible appropriate escalation, communication, and closure of significant quality events.
Batch Disposition & Product Release
Oversee batch record review and product disposition processes.
Ensure robust review processes support compliant and timely product release.
Assess and address quality issues impacting batch disposition.
Sterility Assurance
Provide leadership for sterility assurance via the Sterility Assurance function.
Ensure implementation, maintenance, and continuous improvement of the site Contamination Control Strategy (CCS).
Oversee contamination control practices, aseptic manufacturing, environmental monitoring, and utilities microbiological risks.
Ensure compliance with regulatory expectations and industry best practices for sterile product manufacturing.
Continuous Improvement & QA Operational Projects
Lead QA-driven projects and cross-functional improvement initiatives.
Promote structured problem solving, risk management, and sustainable implementation of improvements.
Ensure QA support for operational transformations and site-level projects
Performs other duties as assigned by management
Department Specific/Non-Essential Functions:
Participate in site initiatives, inspections, audits, and special projects as assigned
Support cross?functional quality improvement or cultural initiatives
Provide mentorship, training, or ad hoc guidance to quality or operations staff
Contribute to site readiness activities and leadership forums as needed
Performs other duties as assigned by management
