Quality Assurance Operations Manager Job

The QA Operations Manager will play a key role in driving the organization’s Quality Mindset and fostering a culture of efficiency, precision, and timely delivery. Working closely with the Director of Quality Assurance, the Operations Manager, and Manufacturing Science and Technology (MSAT) teams, this role will focus on strengthening operational performance while ensuring consistent adherence to quality standards.
The successful candidate will navigate audits effectively, identifying and addressing operational and quality gaps to support continuous improvement efforts.
With a strong emphasis on collaboration, the QA Operations Manager will cultivate positive, customer-centric relationships with internal teams, customers, suppliers, and partners. This role requires exceptional interpersonal skills and the ability to communicate complex issues clearly and concisely to a variety of stakeholders, both in written and oral formats.
A strong team player, the QA Operations Manager will also excel in working independently, leveraging superior self-management and organizational skills. They will recognize the value of process owners and subject matter experts and will demonstrate the ability to influence positive outcomes, even without direct reporting authority.

Bachelor’s Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
Minimum of 8 years of Quality Assurance experience in biopharma aseptic manufacturing industry.
Isolator-based aseptic processing experience.
5+ years of experience as a people leader or supervisor.
Expert level of understanding and oversight of contamination controls, drug product manufacturing processes, and output quality. Prior experience and comfort with making risk-based decisions to ensure product quality is required.
Possesses excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Operations and Quality.
Exceptional computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).