Operational Quality Specialist

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary:

You will provide operational quality oversight on site to help ensure safe, compliant and reliable supply. You will work closely with production, laboratories, engineering and quality teams. We value practical problem solvers who make clear decisions, coach others, and act with integrity. This role offers hands-on learning, visible impact on product quality, and career growth in a leading, mission-driven organization united to get ahead of disease together.

Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues.

• Accountable for quality decision making via work order assessments, atypical comments, and initial impact assessment for deviations.

• Provide on‑the‑floor quality oversight, perform regular shopfloor walk‑throughs, and detect early quality risks.

• Review executed and master batch records, deviations, and associated CAPA plans for completeness and compliance.

• Approve or recommend disposition decisions and support lot release activities under defined procedures.

• Support and perform self‑inspections, internal audits, and inspection readiness activities.

• Responsible for review, release and second check of batch record documentation for compliance and regulatory requirements.

• Ensuring GMP documentation and records follow Good Documentation Practice (GDP) by adhering to principles for data integrity through both review and end-user support.

• Provide timely 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 includes production, testing, cleaning and maintenance activities.

• Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.

• Ensure facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated.

• Review and approve GMP documentation, including change controls, validation summaries, and procedural updates.

Why You?

This role is on-site at a United States manufacturing location and requires regular presence in production and laboratory areas. We welcome applicants who are collaborative, curious, and committed to continuous improvement. We are committed to inclusion and want people who will help create a respectful, supportive workplace.

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in a scientific, engineering, or technical discipline; or equivalent experience.

• 2+ years of experience in a regulated life sciences manufacturing or quality role.

• 1+ year of experience with Good Manufacturing Practices (GMP) and good documentation practices.

• 1+ year of experience reviewing batch records and GMP documentation.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in biologics or pharmaceutical manufacturing environments.

• Experience with deviations, CAPA, change control, and validation activities.

• Training or experience in root cause ana