• Shire
  • $157,450.00 -157,450.00/year*
  • North Reading , MA
  • Non-Executive Management
  • Full-Time
  • 55 Oakdale Rd

Primary Duties:The Senior Materials Management Compliance Specialist s responsibilities will be to lead the investigations into Materials Management (MM) owned CAPAs, Change Controls, RMNCMR deviations, and level 2 deviations. They will manage the closure within established timelines work with QA and management to escalate quality systems when necessary. Additionally they will act as a MM SME for projects to support the MA Biologics Operations. They will also support the MM Compliance Manager in internal and external audits and work to improve the overall compliance of the MM department.Responsibilities:Influence the organizational control of Quality systems:Own MM deviations, CAPAs, and Change ControlsLead cross-functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations to management on batch dispositionProvide subject matter expert input for MMResolve conflicts that arise, escalate as needed.Work cross-functionally and represent MM on Lexington Site projects to include process improvements, tech transfers, new materials and equipment, decommissioning, and investigations.Support internal and external audits by acting as MM SME and liaison. Provide assistance in responding to observations to include implementing corrective actions and process improvements.Identify ways to improve compliance within the MM department. Work with the Compliance Manager and other members of the leadership team to make positive change.Participate in regulatory and internal audits which may include direct interaction with inspectors for CAPA or Change Controls, scribe duties, facilitation of audit requests, and/or development of responses.Education and Experience Requirements:Bachelor s in Science or a related discipline, Master s preferredMinimum of 5 years related industry experience in the manufacturing and/or development of biologics, pharmaceuticals or devices preferred Previous technical writing experience preferredPrevious experience owning manufacturing deviations/investigations preferredExperience with managing multiple commodity areas and tasks effectively in a fast-paced work environmentERP experience in Inventory Warehouse Management / Materials Management / Procurement modulesExperience with New Product IntroductionAbility to manage work and influence decisions in a high matrix organizational environmentDemonstrated ability to manage collaboration and influence cross-functionally for process improvement initiativesExperience working in a high growth environment with changing priorities is essentialExperience in manufacturing procedures, shop/work orders, working in a GMP regulated environment preferredExperience in the Biotechnology, Medical Device, Pharmaceutical or other Medical-related fields preferredDemonstrated project management skillsCertifications preferred: CQA, APICS, or PMPKey Skills, Abilities, and Competencies:Strong written and verbal communication skillsDemonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organizationWork is performed with minimal direction/supervision.Ability to lead and influence investigation team members to coordinate work based on priorities Must be proficient with record management systems such as TrackWise (or equivalent)Must be proficient with Microsoft Office applications, including Word, Excel and Power Point. Experience with more advanced Microsoft applications including Visio, Project, and SharePoint a plusExperience with other related applications a plus (e.g. LIMS, SAP, OSI/PI)Complexity and Problem Solving:Ability to identify priorities manage numerous projects simultaneouslyLead problem resolution meetings/teams effectivelyAbility to shift priorities to meet required deadlinesEffectively identify risks and communicate issues cross-functionally in a timely mannerThorough understanding of biopharmaceutical manufacturingComprehensive understanding of industry regulations and cGMP complianceAbility to apply industry regulations to decision making process Strong presentation skills Strong problem-solving skills and attention to detailInternal and External Contacts:Facilitates, consults and collaborates with cross-functional teams including but not limited to Manufacturing, Facilities and Engineering, Manufacturing Sciences & Technology, Quality Control, Validation, Operational Excellence, and Health, Safety & Environment, and, Quality Assurance.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 OpportunityShire, 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 - is the Law Supplement - Transparency Policy - AccommodationsShire, 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.Full time

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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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