myGwork - LGBTQ+ Business Community · 2 days ago

Sr. Manager, Quality

Durham, NC

Full-time

Onsite

Senior Level

7+ years exp

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Responsibilities

Creating and leading the strategy for Quality and Compliance, offering guidance to team members and leaders in various functions.

Serving as an expert in the interpretation of GMP compliance requirements.

Providing Quality leadership for the Production Chemicals and Services (PCS) multi-site network.

Building professional relationships with Quality counterparts within customer organizations.

Coordinating collaborations with various teams within Thermo Fisher Scientific to ensure seamless alignment of product value stream interactions.

Driving resolution to quality issues and effectively communicating with senior leaders and diverse audiences.

Mentoring and coaching team members and peers.

Manage site Quality Management Reviews

Manage validation, change control, CAPA and complaint management processes and review boards

Applying Quality Risk Management to prevent failure modes that impact the supply of consistent quality products and services.

Participate in the evaluation and selection of critical suppliers and service providers

Partnering with Global compliance and regulatory teams provide guidance and interpretation on applicable QMS GMP standards, customer requirements, regulations, standards and quality systems

Qualification

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Quality management systemQuality standardsLean sigmaSix sigmaCommunicationProblem-solving