Position Summary: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. We value clear decision-makers who simplify processes, coach others, and drive measurable improvement. This role offers visible impact, career growth and the chance to unite science, technology and talent to get ahead of disease together.
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. Review and approve batch records, certificates and quality documentation to meet regulatory and good documentation standards.
- 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 ensuring all requirements have been met, and the defined schedule is followed.
- Maintain presence across areas of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations.
- Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects
- Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards that include production, testing, QC, warehouse, facilities and utilities.
- 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 following ALCOA++ principles for data integrity, audit and traceability
- Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated and support timely implementation of remedial actions
- Track and trend quality oversight observations on collected data and facilitate mitigation actions and regularly update and maintain the quality oversight risk assessment
- Participates in and supports site-based audits/inspections as SME for Quality Oversight.
Basic Qualifications:We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree in science, pharmacy, engineering, or a related discipline, or equivalent 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.
- Experience across multiple dosage forms, packaging or device assembly activities.
- 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: If you have the following characteristics, it would be a plus:
- 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.
Work model:This role is an onsite position which requires you to be onsite. This is not a hybrid position.
What we value:We act with transparency, respect and integrity. We make evidence-based decisions and balance speed, rigor and risk. We welcome applicants from all backgrounds and support an environment of inclusion where everyone can do their best work.
Ready to apply?If you are motivated to lead operational quality, protect patients and improve systems, please apply. Tell us how your leadership and quality experience will help our team succeed. We look forward to hearing from you.
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