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Senior Director, Quality Assurance

Company: QuVa Pharma, Inc
Location: Sugar Land
Posted on: November 16, 2021

Job Description:

Strategic Position(s) responsible for managing all Quality and associated departments supporting all aspects of compounding sterile and non-sterile pharmaceuticals and regulatory compliance within the facility.. Operates within the legal and regulatory compliance framework, producing a quality product and assuring compliance with relevant CRFs, industry standards with a focus on best in class manufacture and patient safety / benefit.. Operates within all business areas as the most responsible person(s) over the QA and QS staff, and all directly and indirectly associated departments, coordinating roles & responsibilities and projects. Holding ultimate responsibility for product release / recall and patient safety in combination with Pharmacy Services.. Responsibilities may include:. Supervises Manager and Director positions by providing learning and development. Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations.. Oversees the on-time release of batches.. Oversees the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation.. Develops, oversees and reviews actions of others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in place.. Manages others to ensure QuVa quality standards are met at the site so that processes are the same as other QuVa sites.. Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws with an added focus on State BoP requirements. Oversees weekly/monthly reports, to identify trends and prioritize continuous improvement opportunities, provides data to Exec management and ensures Management oversite of all operations. Ensures the design and implementation of site policies and procedures.. Has authority to act as deemed fit on critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirements.. Enforces applicable personnel policies and procedures. Qualifications:. Legally authorized to work in the job posting country. Bachelors degree in Life Science or other related field.. Minimum 15 years prior experience in Quality Assurance / cGMP / FDA regulated industry.. Minimum 10 years of supervisory or management experience required.. Experience with all aspects of pharmaceutical and aseptic manufacturing, monitoring and control.. Technical writing and communication.. Well versed in the compliance & quality requirements of 503B pharmaceutical industry and cGMPs and have demonstrated strength in problem solving and resolution.. Strong interpersonal skills. To be considered:. In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.. Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.. It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Keywords: QuVa Pharma, Inc, Sugar Land , Senior Director, Quality Assurance, Executive , Sugar Land, Texas

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