Manager, Quality Compliance in Albuquerque, NM

　　Summary:

　　Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

　　The Manager, Compliance, is an integral part of the Curia Albuquerque team, contributing to our success by being responsible for the oversight and maintenance of select Quality System elements and overall Regulatory Compliance. The role responsibility includes leading the Quality Systems internal/external audits, APQRs and customer regulatory support. The role includes implementation of Quality System elements that align with Curia Global Standards and Procedures, ICH Q10, FDA CFR 210 and 211, EMA and all applicable regulatory guidance, maintaining a robust inspection readiness program to ensure inspection readiness at all times, lead and drive gap assessments and remediation plans for various internal and external regulatory findings.

　　Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

　　Essential Duties and Responsibilities:

　　Lead and streamline the APQR process for annual customer reports. Ensure timely delivery to customer by utilizing internal team and Curia corporate resources (GSS)

　　Lead continuous improvement of Quality Systems, internal/external audits, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems

　　Lead and execute a wide variety of continuous improvement activities to ensure compliance with applicable quality objectives and regulatory requirements

　　Provide guidance and support to the facilities to ensure Quality Systems continuously meet regulatory compliance and continuous improvement goals and objectives

　　Lead cross-functional teams to complete projects, address quality issues and drive implementation plans for Quality System improvements

　　Monitor Quality Systems via metrics for trends and notify management of events requiring immediate action

　　Support QIPs associated with site quality improvement initiatives

　　Responsible to ensure a robust inspection readiness program is in place for the Albuquerque facilities

　　Interact and influence team, peers to ensure compliance with internal SOPs and regulations

　　Responsible to ensure all customer audit responses and regulatory inspection responses are completed in a timely manner and commitments are executed on time

　　Maintain current knowledge of GMP Compliance program and of applicable company standard operating procedures for areas of responsibility

　　Provide guidance on interpretation and application of specified QA/GMP compliance regulations, i.e.: 21 CFR Part 210/211

　　Supervisory Responsibilities:

　　Not Applicable

　　Education and/or Experience:

　　A Bachelor’s degree in the Sciences and five (5) + years in quality assurance and/or compliance/auditing experience within the pharmaceutical industry OR seven (7) + years relevant experience, of which three (3) + years is in the pharmaceutical industry.

　　Language Skills:

　　Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

　　Mathematical Skills:

　　Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

　　Reasoning Ability:

　　Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

　　Computer Skills:

　　To perform this job successfully, an individual should know Database software; Manufacturing software; Spreadsheet software, and Word Processing software. Proficient in the use of MS Word, Excel, Outlook, and Access

　　Other Skills and Abilities:

　　Proficient in problem-solving techniques and demonstrates the ability to troubleshoot with limited supervision. Technical resource for routine issues about compliance with regulatory requirements as needed. Review reports and documents proficiently for completeness and accuracy. Ability to organize time for multiple tasks and respond to high-priority tasks when necessary.

　　Delivers assigned tasks on time. Independently read pharmaceutical publications to be apprised of industry trends. Attend industry led-training courses, as appropriate.

　　A reasonable degree of initiative thinking to resolve problems is required. The work is routine to moderately complex but covered by well-defined policies, procedures, and regulatory guidance. This position will require the ability to resolve problems, requiring some independent judgment.

　　Actions to be taken will be discussed with the supervisor before resolving non-routine problems. Knowledge of technical writing and technical terminology including technical writing skills. Ability to assess and communicate regulatory risks.

　　Knowledge of aseptic processing and regulatory and industry guidelines and requirements. Ability to train and counsel Quality professionals and production personnel. Knowledge of cGMPs, GDPs, as well as, sound quality and regulatory principles consistent with ‘best practices.’

　　Leadership qualities required. Attention to detail required. Ability to read, understand, interpret and apply technical writing and instructions. Good verbal and written communication skills.

　　Other Qualifications:

　　Must pass a background check

　　Must pass a drug screen

　　Physical Demands:

　　While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to handle or feel. The employee is occasionally required to stand, walk, reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

　　Work Environment:

　　While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation, and vibration. The noise level in the work environment is usually moderate.

　　Note

　　This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

　　All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.