Senior Compliance Specialist

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Job Summary Sr Assoc, Quality Systems is responsible for leading the coordination of Change Control activities and ensuring compliance with internal and external Change control requirements.

The role will serve as the subject matter expert and administrator for change control documentation.

Essential Duties and Responsibilities Oversee overall global Change Control process; leading change control review board activities (documentation, data, customer notifications and approvals, etc.)

Collaborate with cross functional teams on West change controls and provide guidance and Quality consultation to change control owners on change levels and associated tasks.

Assist change owners to outline action plans, tasks and responsibilities to ensure execution of changes occur in a timely manner Drive visibility and oversight to changes across network to ensure applicability and consistency.

Oversee assessment of change controls and ensure change impact is considered across products, platforms, life cycle phases, supply chain, and processes (i.e., combination products).

Ensure change control information is accurately entered into the appropriate tracking database Provide mentoring and training to change owners on change control processes and tools Work with global, cross-functional groups, manufacturing sites, and customers as needed to determine compliance with customer specifications.

Monitor and communicate metrics and trend reports to management for the Change Control system as needed Collaborate on cross functional teams in determining specification content.

Evaluate change control processes and tools to drive continuous improvement activities.

Additional Responsibilities Ensure adherence to corporate Quality System requirements Education Bachelor's Degree in Science or equivalent experience required Master's Degree in Science or equivalent experience preferred Work Experience Minimum 5 years of experience in regulated Quality Assurance / Quality Control required Experience with qualifications, Quality Risk Management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities, MasterControl, SAP, SharePoint, Teamcenter preferred Preferred Knowledge, Skills and Abilities Ability to work independently, multi-task and thrive in fast-paced environment Excellent critical reading and writing skills Effective problem solving and interpersonal skills Problem solving including root cause failure analysis methods Planning / organizational skills Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint Able to comply with the company's safety policy at all times Knowledge of cGMP, cGDP License and Certifications Travel Requirements Up to 13 business days per year (5%)

Physical Requirements Sedentary work involving sitting most of the time, exerting up to 10 lbs / 4 kgs of force occasionally.

Additional Requirements Adaptable to changes, manage competing demands, and deal with unexpected events.

Work well with others in various situations Multi-task, prioritize, and problem solve under time constraints Make independent and sound judgments Analyze and interpret situations, maintain high attention to detail Communicate effectively with internal teams and customers Follow SOPs as per company policy and Quality Manual #J-18808-Ljbffr