Quality & Regulatory Lead

Payrate: $44.92- $44.92/hr. Summary:Quality & Regulatory Lead (QRL) ensure that network of External suppliers / CMO’s / partners is supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/ applicable GMP/GDP regulations.The QRL is also the liaison between the site and Global Regulatory Science (GRS), works collaboratively with Contract Manufacturing Organizations (CMOs), Virtual Site Operating Teams VSOTs (External Supply), and Regulatory colleagues to determine when the Regulatory Change Management Process is required. Responsibilities:Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials/product(s) to according to established procedures.Provide Quality Leadership and act as regulatory expert within the VSOT, advising of regulatory strategy and potential supply constraints if any.Assess the quality of external supplier’s products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.Support internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors - (RQA audits or regulatory inspections) as applicableSupport internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence Requirements:Minimally 5 years of experience in GXP setting and/or Regulatory Affairs role (Pertinent Master's degree required).Expertise in external suppliers/contractors, Change Management and Regulatory.Experience with relevant QTS & eQMS modules.Demonstrated technical know-how, knowledge, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices.Is diplomatic, clear & succinct in communication with internal and external stakeholders.Committed to the Change Management Best Practices to enable improvement of the Change Management Process and System.Embraces innovation and change to find solutions.Strong project management skills. Demonstrated success leading global Projects.Collaborative and embraces mindset: Courage, Equity, Excellence, Joy, strong interpersonal and influential skills.Proficient in English and technical writing and strong verbal, written communication, and presentation skills.Decision-making based on a science-based risk approach.Demonstrated experience managing complex quality & compliance activities, problem solving attitude and open to innovation, takes initiatives and is proactive, persistent.Demonstrated ability to act and work independently and to report items as required to line manager.Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.Pay Transparency: The typical base pay for this role across the U.S. is: $44.92- $44.92/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.   Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary. 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