Quality Assurance Manager

Payrate: $52.00 - $54.00/hr. Summary:Computer Systems Validation experience is mandatory. Ability to interpret and apply GMP, GLP, and GCP regulations. Validation and change control experience is required. Strong documentation, operational, and guideline compliance experience. No specific degree requirement - candidates with extensive Computer Systems Validation experience are acceptable regardless of their degree field. Strong communication skills (written and verbal). A team player who can collaborate effectively. Ability to handle escalations professionally and de-escalate conflicts. Must be proactive and engaged, rather than just following procedures passively. Responsibilities: Act as Quality Assurance (QA) contract for Change Control(s) for Computerized System activitiesReview and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)Change Agent and advocate for the Risk Based Validation programAble to act as SME for multiple Quality processes (e.g. Deviations, CAPA)Review and Approve SOPs and associated documentsReview/Approve Periodic Reviews for GxP SystemsMay perform Supplier Evaluations as neededSupport project initiatives, process improvements and or projectsMay be required to present on topics or issues to managementMay support audit & Inspections requests as neededMay support other duties as requiredSkills:Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)Strong organizational skills, including ability to follow assignments through completion.Initiate and lead cross functional teams as neededCollaborate and communicate with higher level outside resources.Strong communication (both written and oral), facilitation, and presentation skills.Strong skill in working independently and to effectively interacting with various levels of managementAbility to lead and influence staff outside QA organizationAble to manage performance issues and conflictAbility to evaluate documentation/ operations according to company and regulatory guidelinesAbility to interpret and apply GMP, GLP, GCP, GPvP regulations Preferred Qualification:5+ years’ experience in a regulated industry in a similar role (e.g. Biotechnology, Medical Device, Aerospace)Demonstrated strong Knowledge of industry and business principlesDemonstrated strong problem-solving abilities and strong risk assessment capabilities Nice To Have Skills:Experience working with Veeva or Safety Systems is a plus but not required.Knowledge of industry-wide regulatory systems Must Have Skill:Prior experience with Computer Systems validation and risk-based decision makingProject management experience preferredAbility to evaluate documentation/operations according to company and regulatory guidelines Education:Master’s degree in technical or related subjects and 3 years with direct experienceBachelor’s degree in technical or related subjects and 5 years with direct experienceWill consider those that have significant years of direct experience in lieu of education requirements Pay Transparency: The typical base pay for this role across the U.S. is: $52.00 - $54.00 /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, dental, and vision 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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