Description
You will lead a small Operational Quality team that provides quality oversight across manufacturing. You will work closely with manufacturing and supply chain colleagues to protect product quality and patient safety.
Responsibilities:
- Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System.
- Monitor quality performance using metrics and trends, escalate risk, and collaborate on corrective action plans.
- Oversee investigations of deviations, non-conformances and complaint-related issues and drive robust root cause analysis.
- Support product introductions, transfers and changes, prepare for and support audits and inspections, and coach internal teams and external partners on inspection readiness.
- Provide oversight, support, and accurate scheduling of activities to the quality team responsible for quality oversight of all GMP areas.
- Maintain presence across areas of responsibility and be the first line of contact to support initial management of quality issues.
- Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time.
- Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards.
- Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.
- Review GMP documentation and records ensuring Good Documentation Practice (GDP) is being maintained.
- Check that facilities are being maintained in a good state in line with local housekeeping standards.
- Track and trend quality oversight observations on collected data and facilitate mitigation actions.
Basic Qualifications:
- Bachelor’s degree in science, pharmacy, engineering, or a related discipline, or equivalent pharmaceutical industry experience.
- 6+ years of manufacturing experience from pharmaceutical industry, biologics manufacturing, distribution, supplier quality, or quality operations.
- Experience with quality systems such as deviations, CAPA, change control, and document control.
- Experience with data trending, statistical analysis, and root cause analysis tools.
- Proven experience and strong knowledge of the application of the principles of Quality Management Systems (QMS).
- Strong written and verbal communication skills for cross-functional collaboration and supplier engagement.
Preferred Qualifications:
- Leading or supervising a quality team in operations or supplier quality.
- Working knowledge of Good Manufacturing Practices and applicable U.S. regulatory expectations.
- Familiarity with inspection readiness and supporting regulatory inspection responses.