Design Quality, Late-Stage Development Manager

Responsibilities

• Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the combination product/device. Analyze and justify the impact on cumulative changes.
• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
• Guide project development as a team member in global and local product development teams for Combination Products to proactively and appropriately address quality-related issues. Advise internal business partners with regard to medical device/combination product regulations.
• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
• Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
• Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues for sterile and unsterile devices and elevates medium and high-risk events to AbbVie management.
• Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
• Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required.
• 7+ years of total combined experience. At least 5 years in Operations Quality Assurance, 3 years in Operat

Benefits

Additional Information

Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Abbvie? Share your experience