The Product Quality Lead provides cross-functional quality leadership and supports program deliverables for assigned products and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle. The PQL is the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products. Please not this is a hybrid role that requires on-site presence in one of our offices (Morrisville, NC or San Diego, CA). Key responsibilities: Including, but not limited to the following 34 Ensure end-to-end compliance for product manufacturing and life cycle management, from clinical phase the termination of the commercialization of the product (as applicable) 34 Provide Quality inputs in submission dossiers 34 Implement and maintain Quality Risk Assessment and KPIs 34 Lead complex changes 34 Coordinate product QA activities across markets (e.g. launch) 34 Provide guidance on product quality aspects and support site transfers 34 Participate in audits and inspections 34 Design SOPs and contribute to operational development 34 Contribute to input in Quality aspect of Due Diligence processes 34 Advice / leads Complex quality issues and influence global solutions to ensure continuous drug supply to patients. 34 Collaborates closely with the rest of the Quality functions to ensure product quality requirements, issues, or solutions are promptly communicated at all appropriate levels 34 Support recall 34 Responsible for coordination / issuing and approval of the APQR 34 Contribute to developing and streamlining own operations 34 Lead & coordinate Quality aspect for integration of new acquisitions 34 Cooperate with team members and contribute to a positive work environment Qualifications 34 High-level education in pharmaceutical, biotech, or life sciences 34 At least 10 years of experience in pharmaceutical and biotech products under GMP 34 Proven experience in Pharmaceutical Development Organization being able to transition development projects into future commercial set-up. 34 Strong leadership skills with a proven track record with Health Authorities 34 Deep understanding of GMP & GDP requirements and strategic planning 34 Fluent in English with excellent communication and interpersonal skills Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. The base salary range for this role is $125,000-$165,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.