**Otsuka Pharmaceutical Europe is proud to be an equal opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all Employees. All qualified applicants will receive consideration for employment regardless of their race, color, religion, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or any other protected status.** **Otsuka Pharmaceutical Europe is committed to ensuring our hiring process is accessible to everyone. Should you require any accommodation or adjustments during the application or interview process, please do not hesitate to let us know.** **Description of the role:** Contribute to the management of the Otsuka Europe quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate, and that Otsuka Europe fully complies with all relevant legislation and industry recommended practice. Support in the management of suppliers and service providers ranging from manufacturing and automated packaging to distribution activities throughout Europe, used by Otsuka Europe and Otsuka’s other Global Organisations. **Important Responsibilities:** Support maintenance of overall audit schedule of contractors and suppliers based on an appropriate risk assessment and qualification process. Perform GxP audits at Otsuka Europe partner sites, within Europe. Follow up on supplier audit reports and where required ensure adequate corrective and preventative actions are in place. Includes advice on and agreement of actions and monitoring the effectiveness of those actions. Contribute to the development, maintenance and improvement of supplier management policies, standards and procedures. Participate in supplier development projects and continuous improvement activities focusing on supplier quality. Assist in internal audits and regulatory audits and inspections. Help maintain an Approved Supplier List and define areas to be targeted during the assessment or evaluation. Help track supplier quality on a monthly/quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions. Identify and leverage best practices across supplier qualification, surveillance, process and quality management system audits. Contribute to the development and maintenance of the quality system to assure compliance with GMP and GDP Prepare and maintain GMP documentation such as standard operating procedures and Quality Technical Agreements Work with suppliers for the development, agreement and documentation of processes Assist in supplier related changes and implementation of required actions to address changes. Assist in ensuring that the requirements and conditions of the Company’s product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures. Liaise with suppliers for the management of returned/defective product Assist in collecting, collating and compiling data for periodic product quality reviews, including preparation of reports Contribute to Global Quality goals, projects and initiatives Provide support and advice relating to the manufacturing and technical content of the Company’s product licences and submissions. Ensure that the requirements and conditions of the Company’s product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures Manage and maintain systems for change control, deviations and CAPA Provide additional support to the QA Department through assisting in - Implementation of variations - Writing quality agreements Provide support to other functions within the OPEL Global Product Quality team, such as: Conducting training sessions on Quality processes and systems Providing support to regulatory inspections Batch record reviews **Qualifications and Experience:** Degree level plus, further qualification in auditing desirable Experience working in a Pharma Quality Role with exposure to auditing. Excellent written and spoken English. Industry experience of manufacturing, automated packaging and distribution sites (GMP and GDP) **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. 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