Manager, Quality Operations

Title: Manager, Quality Operations Company: Ipsen Biopharmaceuticals Inc. Job Description: Manager, Quality Operations Location : US - Cambridge (Hybrid) Summary / purpose of the position The Quality Operations Manager, based in Cambridge, MA, is a full-time permanent position responsible for maintaining commercial Quality Operations compliance within Ipsen Biopharmaceuticals, Inc. The Manager will assist in maintaining the Quality Management System of the US commercial affiliate, lead the local Training program, and oversee document management in alignment with Global expectations and regulatory requirements, including: Lead local GxP personnel Training program, ensure deployment of training for new and existing personnel, and maintain training matrix. Lead Documentation management including revision and life-cycle management of relevant GxP procedures, policies, and work instructions, reviewing, and providing document content, demonstrating a high level of involvement in continuous improvement, ensuring alignment with organizational needs, and processing documents through an electronic document management system. Triaging, documenting, and responding to Product Complaints, Temperature Excursions, and Quality inquiries for US commercial products. Collaboration cross-functionally to ensure QMS records (including deviations, CAPAs, change controls) are completed in a compliant and timely manner, review for content and compliance, ensure KPIs and metrics are met for local affiliate. Onsite support of regulatory inspections and internal audits Contributing to external audits of applicable service providers and management of Technical Quality Agreements. Other tasks as assigned related to Quality Operations, including new product launches support. Adherence to all applicable Ipsen local and global SOP's, policies, and regulatory requirements. This role, reporting to the Sr. Director Quality Operations, will work in collaboration with local affiliate functions including PV Safety, Medical Information, Regulatory, Legal, Trade, Supply Chain, and Patient Services. Main responsibilities / job expectations Responsibilities will include, but are not limited to the following: Day-to-day management of local Training program for GxP employees Act as Lead for Documentation management process, including revision and life-cycle management of relevant GxP procedures, policies, and work instructions and review for content and format. Main contact for Product Complaints review, impact assessment and responses, Temperature Excursions, product replacement requests, quality inquiries, and logistics complaints for distributed commercial products Communication, initiation, and management of quality events (deviations), corrective and preventative actions, and change controls, supports local functions in execution of QMS providing content and eQMS system expertise. Maintain and report on KPI metrics. Development and maintenance of Quality Technical Agreements as needed. Assists in or performs internal and external audits. Assists in hosting inspections or audits by regulatory authorities, Ipsen Global Quality Audit function, and others as needed. Alerts management of any potential product risks. Establishing and maintaining relationships with local GxP teams. Supports new product launches and integration of acquired assets, as needed. Other tasks as assigned related to Quality Operations, as needed. Completing and maintaining up-to-date training and training records for self on functions performed. Adhering to all applicable Ipsen SOP's, policies, and regulatory requirements. Maintains a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GDP/GCP/GVP regulations; disseminates Quality culture and awareness across all functions. Complies with all applicable laws, regulations and policies that govern the conduct of Ipsen U.S. staff. Knowledge, abilities & experience Education / Certifications: Bachelor's degree or higher, preferably in science related area Experience: 5+ years of relevant experience executing, developing, and/or administrating GxP Quality programs in a pharmaceutical and/or biotech environment at a minimum. Experience in writing, reviewing, and implementing SOP's and quality systems (deviations, CAPAs, change controls) is essential. Experience in GxP Training management. Experience with eQMS electronic platforms for quality systems management and training is preferred. Languages: Fluent in English Key Technical Competencies Required Strong knowledge of US FDA GVP, GDP, and GxP regulations. An inherent interest in compliance and quality development of self and of the organization. Highly organized and detail oriented. Strong demonstrated communication skills Agile in decision making, Ability to collaborate across departments and levels. Proficiency in Microsoft Office suite, including Word, Excel, and PowerPoint required. Up to 10% travel required for this role. The annual base salary range for this position is $109,800-$134,200. This job is eligible to participate in our short-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Created: 2024-10-19