Operational QA Manager

The QA Operations Manager will be essential in fostering a strong quality mindset across the Lenexa campus, creating a culture where quality-focused actions are prioritized, and promoting discussions about quality throughout the site. Key responsibilities include overseeing the Lenexa Change Control Board, managing the Deviations and Complaints program, and conducting Product Quality Reviews. The manager will collaborate with the Operations Director and the Manufacturing Supervisors team to improve operational performance while ensuring compliance with quality standards and maintaining excellence in all processes. This position requires outstanding interpersonal skills and the capacity to articulate complex issues clearly and concisely to various stakeholders, in both written and verbal communication. The candidate will understand the significance of process owners and subject matter experts, effectively influencing positive outcomes even without direct reporting authority.

·         Lead and manage a QA operations group to ensure compliance with quality standards, cGMPs, and regulatory requirements by applying expertise to maintain inspection-readiness and serve as a key point of contact during audits.

·         Manage the Change Control Program by coordinating Change Control Board activities and ensuring all actions are completed on time. Collaborate with change control owners to ensure the timely completion of all necessary actions.

·         Oversee and coordinate deviation investigations as a subject matter expert, utilizing root cause analysis and risk mitigation tools to resolve issues and prevent recurrence. 

·         Gather and organize all required data to ensure timely preparation of Product Quality Reviews.

·         Collaborate with team members to ensure that the campus is always ready for inspection and actively participate in External Inspections.

·          Work with HSE and Operations to ensure safety compliance by clearly communicating expectations, assessing behaviors, and enforcing SOPs and quality guidelines.

·         Drives ambition and Accountability by monitoring employees’ effectiveness and standards of excellence, communicating the expectations, and challenging one another.

·         Inspires others by communicating with transparency, honesty, and powerful, relevant data.

·         Adopts an open-minded attitude towards fellow team members to respect and support their contributions.

·         Fosters an environment of transparency and regular communication to improve awareness and efficiency

·         Consider exploring various trends and ideas to enhance our perspective on solutions.

·         Facilitates clear communication to effectively address any concerns and needs.

·         Skilled in implementing and enhancing quality systems in the pharmaceutical industry.

·         Knowledge of 9 CFR and EU-GMP regulations

·         Capable of organizing and prioritizing multiple tasks effectively.

·         Excellent interpersonal and networking skills

Education – BS or BA in a life science or business-related field is required.

·         Work Experience – 3+ years in a Quality or Regulatory role within a 9 CFR environment is required, with experience in a GMP environment preferred.

·         Strong computer skills in reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.) is preferred.

·         Experience with MRP systems (such as JDE or SAP) and Quality Management System software (like CQMS, Trackwise, or Veeva) for managing deviations, change control, and complaints is preferred.

·         Ability to read, write legibly and communicate in English

·         Visual Inspection

N/A

5-10% depending on business needs

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job.  This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job.  This job description is not an employment contract.  Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal Contractor

**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

669B

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