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.
Influence the organizational control of Quality systems:
- Own MM deviations, CAPAs, and Change Controls
- Lead cross-functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations to management on batch disposition
- Provide subject matter expert input for MM
- Resolve 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 preferred
- Minimum of 5 years related industry experience in the manufacturing and/or development of biologics, pharmaceuticals or devices preferred
- Previous technical writing experience preferred
- Previous experience owning manufacturing deviations/investigations preferred
- Experience with managing multiple commodity areas and tasks effectively in a fast-paced work environment
- ERP experience in Inventory Warehouse Management / Materials Management / Procurement modules
- Experience with New Product Introduction
- Ability to manage work and influence decisions in a high matrix organizational environment
- Demonstrated ability to manage collaboration and influence cross-functionally for process improvement initiatives
- Experience working in a high growth environment with changing priorities is essential
- Experience in manufacturing procedures, shop/work orders, working in a GMP regulated environment preferred
- Experience in the Biotechnology, Medical Device, Pharmaceutical or other Medical-related fields preferred
- Demonstrated project management skills
- Certifications preferred: CQA, APICS, or PMP
Key Skills, Abilities, and Competencies:
- Strong written and verbal communication skills
- Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
- Work 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 plus
- Experience with other related applications a plus (e.g. LIMS, SAP, OSI/PI)
Complexity and Problem Solving:
- Ability to identify priorities manage numerous projects simultaneously
- Lead problem resolution meetings/teams effectively
- Ability to shift priorities to meet required deadlines
- Effectively identify risks and communicate issues cross-functionally in a timely manner
- Thorough understanding of biopharmaceutical manufacturing
- Comprehensive understanding of industry regulations and cGMP compliance
- Ability to apply industry regulations to decision making process
- Strong presentation skills
- Strong problem-solving skills and attention to detail
Internal 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.
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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.
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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 484-595-8400 and let us know the nature of your request and your contact information.