Sr R&D Quality Assurance Engineer F/M

Job Overview

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on peoples lives. R&D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the product lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.

Responsibilities

• Support R&D teams in implementing the design control process: you contribute to the preparation, review and approval of product development quality deliverables.
• Participate in design reviews, analyze needs and specifications, and monitor design changes after transfer.
• Write and approve the deliverables of design files and the resulting quality documents (e.g., specifications, protocol and R&D stability reports).
• Ensure product compliance through risk management throughout the product life cycle.
• Update risk analyses in connection with non‑compliance processes, changes, and design changes.
• Contribute with partners to establish means to guarantee an acceptable level of risk.
• Coordinate and carry out quality actions relating to the control of R&D clinical product (approval of system documents).
• Ensure that the corrective and preventive actions necessary following a non‑compliance are implemented, monitored and their effectiveness verified.
• Support investigations when there is a problem to be solved.
• Deploy the quality culture with partners as quality representatives in projects.

Qualifications

Education & Experience

• Bachelor's degree required, preferably in biomedical engineering, mechanical engineering, chemical engineering, pharmaceutical sciences, or related discipline. Master's or Ph.D. in related field advantageous.
• Industry experience in pharmaceutical, device, combo/device, research development, manufacturing, quality systems, aseptic techniques and cleaning, or comparable experience.
• Expertise and experience in interpretation and application of quality assurance/controls of regulatory requirements.

Skills & Abilities

• Communication skills, including negotiation and influencing skills, acute listening, and ability to manage difficult conversations.
• Strong strategic, creative, and big‑picture thinking; demonstrated executive presence to anticipate and identify potential issues early and mitigate them.
• Ability to facilitate instructor‑led training programs on complex quality assurance/control topics (ISO13485, FDA regulations, 21 CFR Part 820, and other applicable worldwide and regional regulations).
• Ability to partner with cross‑functional teams at the site and globally to support new product development initiatives and drive the quality culture.
• Ability to prioritize and balance multiple tasks simultaneously and satisfy stakeholders.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.