QA Manager, 3rd Party (US Pharma & Biotechnology)

The position will oversee and manage Quality Assurance, Product Compliance in accordance with the applicable regulatory requirements (e.g. GMPs for US FDA, Canada, EU, and US-EPA) and Ceva corporate guidelines for all third-party manufacturing in US. The candidate must possess a high level of experience and knowledge of pharmaceutical industry regulatory guidelines and ability to interact effectively with contract manufacturer (CMO's) and product distribution organizations. The QA Manager, 3^rd Party will assess the risk to Ceva regarding quality matters and communicate and escalate any critical situation to the upper management. This position will oversee and manage ~30 CMOs for US products (directly and indirectly) and the 3^rd Party QA Specialists in US (currently 3 FTEs).

* Right level of Quality: Participate in decision-making for major product/project issues, escalate critical issues relating to Product Quality to management, report Quality KPIs on monthly basis, participate in QA process harmonization between campuses, develop and maintain strong relationships with internal stakeholders (GID, GEM KAM, RA, PV, Supply Chain, Legal, etc)

* QMS & Documentation: Ensure implementation, update and appropriate storage of Standard Operating Procedures ("SOP") in line with job, participate to Quality community building , ensure Quality Agreements & all other applicable Quality documentation for CMOs are implemented and reviewed (e.g. MBR), coordinate with the US teams Quality Issues from CMOs, assess the risk and escalate to management when needed, assess root cause and develop effective CAPA plan, evaluate with team CMOs related complaints

* Audit & Inspections: Ensure that CMOs are qualified (audits & follow up), build and follow annual audits planning for US CMOs, ensure US team is trained on QA audits techniques.

* Management: Allocate appropriate resources to provide the right QA oversight of CMOs, develop and mentor employees by providing regulatory and QA guidance and expertise (talent management, individual development plan, objectives setting and performance ...), manage the local budget.

* All other duties as assigned

* Shape solutions out of complexity

* Client focus

* Collaborate with empathy

* Engage and develop

* Drive ambition and accountability

* Influence others

Education - Bachelor's degree in applicable scientific field (Quality Management, Pharmaceutical Engineering, Chemistry, Biology) required.

Work Experience - 10+ years of experience working in a Quality Assurance department.

Biological and Pharmaceutical industry investigative/compliance experience, wide range of regulations knowledge (FDA expert, Food, Supplement, etc.), as well as expertise in sterile manufacturing environment are required.

Other - Knowledge of French language desired but not required. Quality Auditor certification preferred. Experience with Pharmaceutical Quality Management software systems preferred.

Up to 30% to affiliates, facilities, and third parties, with some international travel required

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.

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