This position will oversee and manage Quality Assurance and Product Compliance in accordance with the applicable regulatory requirements (e.g. GMP's for US FDA, Canada, EU, and US-EPA) and Ceva corporate guidelines. The successful candidate must possess a high level of experience and knowledge of pharmaceutical industry regulatory guidelines and ability to interact effectively with contract manufacturer's (CMO's) and product distribution organizations. The Global 3rd Party QA Specialist will assess the risk to Ceva regarding quality matters and communicate the potential risks to Ceva upper management.

Quality Assurance through Audits and Investigation

* Perform external audits for Ceva activities ensuring the preparation of complete, concise and timely investigated reports

* Ensure CAPA, change control activities are followed-up and closed out properly

* Perform qualifying and oversight audits of CMOs who manufacture, package, and test EPA, FDA veterinary pharmaceutical products or products with other applicable regulations or guidelines

* Develop and manage a system to ensure all quality investigations and audit deficiencies are properly abated

* Receive CMO related complaints, evaluating them as product quality defects, supply chain

* Responsible for investigations with CMO into product diversion and related issues

Document Management

* Under limited supervision, implement and administer a Standard Operating Procedures ("SOP") program aligned to proper regulatory and business practice requirements

* Write and/or edit SOPs pertaining to the Quality Assurance responsibilities and duties

* Ensure consistency and appropriate storage of documents

Provide Quality Oversight of Ceva Contractors

* Write Quality Agreements for CMOs. Review and approve critical GMP documents from the CMO (e.g. MBR, specifications)

* Receive notification of Quality Issues from contractors; assess the risk to Ceva, communicate risk factors to Ceva management. Develop appropriate risk management strategies

* Work with contractors to investigate Quality issues, assess root cause and develop effective CAPA; plan and coordinate annual quality meetings with critical contractors

* Develop Key Quality Performance Indicators for Ceva contractors; define with contractors metrics on their KPIs and communicate them to Ceva management

* Review product annual reports and investigational information for regulatory compliance and quality risk

* Provide regulatory guidance and expertise

* Shape solutions out of complexity - Is open and curious of others perspectives

* Client focus - Has in mind clients satisfaction

* Collaborate with empathy - Has a positive attitude towards collaboration

* Engage and develop - Clarifies short-term directions

* Drive ambition and accountability - Proactively manages own and others work

* Influence others - Communicates effectively

* Ability to maintain a professional demeanor even when confronted with stressful and/or potentially adversarial situations

* Demonstrated ability to effectively interact with multiple cross functional teams (IT, HR, Regulatory, Customer Services, Sales, Legal, Field Sales, vendors, etc.)

* Must be capable of simultaneously handling multiple tasks and project deadlines

* Demonstrated flexibility, willingness to take on new tasks and ability to effectively operate within a fast-paced environment

* Strong interpersonal, written and oral communication skills

* Must be able to consistently demonstrate appropriate confidentiality, integrity and sensitivity in handling all investigation matters

* Proficient with Microsoft Office

* Advanced Regulatory requirements - US and EU GMP

* Demonstrated experience in managing/handling product quality complaints

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

Work Experience - Minimum 10-15 years experience working in a Quality Assurance Department. Pharmaceutical industry investigative/compliance experience is preferred.

Other - Knowledge of French language desired, but not required. Quality Auditor certification preferred. Experience with a Quality Management System preferred.

* Must be able to communicate, write legibly and understand English

* Visual Inspection

Hybrid role available

Up to 40% with some international travel

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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