Primary Duties Management of the Raw Materials Quality Assurance Operations team, including oversight of all investigatory and QA Ops related functions at the North Reading and Belmont facilities Management of raw material record review, batch disposition and material status control activities associated with the Massachusetts Biologics Operations clinical & commercial products Management of QA oversight of material warehousing, sampling, testing and relating activities to ensure ongoing cGMP compliance Oversight of, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs. Serve as QA subject matter expert for internal GMP operations as well as in the resolution of out-of-specification investigations. Interact with and influence vendor personnel in execution of strategy and identification of continuous improvement opportunities which ensure Takeda quality expectations and minimize compliance risk Management of the Change Control process, ensuring controlled implementation of all GMP related changes Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives. Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement. Implementing CI improvements in the Raw Material Value Stream on a continuous basis and participating in site projects and initiatives. Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality. Discretion/Latitude: Work is performed without appreciable guidance. Exercises considerable latitude in determining objectives and approaches to assignments within defined procedures and practices to determine appropriate actions. Responsibilities: 45% of Time: QA Management 45% of Time: Batch Disposition Activities 5% of Time: Regulatory and/or inspection support. 5% of Time: Involvement in other QA activities as required; involvement in departmental and cross-functional teams as required on various initiatives and/or quality events. Education and Experience Requirements Essential: Position requires a Bachelor s Degree (Science-related degree is preferred) and a minimum of 8 years of related experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. Desired: Prior people management experience strongly desired Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask. Competencies: Able to perform functions in accordance with cGMP guidelines. Knowledge of expectations and guidelines in current FDA & EMEA regulations. Demonstrable experience managing, motivating and leading a team. A high level of initiative is required Excellent verbal and written communication skills are essential. Strong project management and organizational skills. Ability to adapt to changing priorities Proficiency with Microsoft applications Word, Excel, Project, and PowerPoint; ability to learn additional software applications, as the need arises. Ability to work effectively in a fast-paced environment Good interpersonal skills required Ability to multi-task in a dynamic environment with changing priorities Strong work ethic Ability to meet challenging timelines, in spite of obstacles Flexible Key Skills: TrackWise, MS Office, Compliance, Science Understanding Adjunct Skills: LIMS, SAP, EDMS, CCMS Complexity and Problem Solving Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Develop solutions to complex problems which require the regular use of ingenuity and innovation. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Ensure solutions are consistent with organization objectives. Networks with key contacts outside own area of expertise. Internal and External Contacts Frequent contact with other internal functions (e.g. QC/QA, Manufacturing, Engineering, Facilities, Validation, Process Development). Represents QA department on investigations/projects. Provides support to individuals presenting during Health Agency Inspections on matters pertaining to QA Operations. Notice to Employment / Recruitment Agents: Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Equal Employment Opportunity Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. EEO is the Law - EEO is the Law Supplement - Pay Transparency Policy - Reasonable Accommodations Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-###-#### and let us know the nature of your request and your contact information. Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task
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