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Director, Quality Control

Company: Veloxis Pharmaceuticals, Inc.
Location: Raleigh
Posted on: February 16, 2020

Job Description:

Veloxis Pharmaceuticals, Inc. is a commercial-stage, specialty pharmaceutical company, headquartered in Cary, NC, that is committed to improving the lives of transplant patients.--We maintain an inspiring and collaborative work environment with challenges and opportunities that encourage professional development and embrace diversity.--We currently have a Director, Quality Control position available in Cary, NC.----Purpose and Scope:This position contributes to the Company's success by providing analytical expertise in representing the Company's Quality Control / Quality Assurance function on project teams.--The incumbent will also ensure that the Company and its contractors operate under the quality standards necessary to meet FDA compliance and cGxPs while meeting the Company's objectives.--This will be achieved through overseeing product release at the Company's third-party manufacturers, packagers and labs, and improving upon the Company's internal quality systems.--Summary of Key Responsibilities:---Provides technical review support of analytical discipline through data trending, managing stability product stability programs, and review of any OOS/OOTs;-----Reviews and approves vendor laboratory investigations, working within project teams and interacting with internal and external customers;---Develops analytical protocols and supports the execution of analytical activities to completion;---Oversees and contributes to the batch release function for cGMP commercial manufacturing, analytical and distribution activities from the contract facilities.--This role will be part of the final authority for product release to market;---Responsible for the development, management, harmonization and improvement of the Company's quality systems and procedures to ensure compliance with all applicable laws, regulations and quality standards in support of cGxP activities;---Oversees and contributes in the timely execution and continuous improvement of all aspects of the quality processes, both internally and at the Company's contract sites, including batch record review, analytical review, change control, deviations, investigations, complaints and CAPAs;---Together with the Sr. Director, Quality Assurance, provides quality oversight of any manufacturing process changes, validations, specification changes, technology transfers, new product acquisitions, etc.;---Reviews and offers Quality oversight in investigator-initiated study requests and promotion material review;---Together with the Sr. Director, Quality Assurance, provides accountability for the qualification, maintenance and audit of global GxP suppliers;---Develops and reports on KPIs for functional areas that reflect department accountability and continuous process improvements;---Together with the Sr. Director, Quality Assurance, acts as co-lead for all regulatory inspections;---This is a "hands on" position with no direct reports.--The incumbent will need to roll up his/her sleeves and contribute to the team's success.--Required Qualifications and Skills:Education:---Bachelor's Degree in a scientific/technical discipline; Master's Degree in a scientific/technical discipline preferredProfessional Experience:---15+ years' experience in the biotechnology / biopharmaceutical / pharmaceutical industry with commercial pharmaceutical products intended for human use;---12+ years' experience working in progressively responsible positions in Quality;---Strong experience interacting with regulatory agencies (e.g., FDA, EMA);---Thorough understanding of GMP, including 21 CFR 210 and 211, EU regulations, ICH guidelines and FDA requirements for pharmaceuticals;---Solid experience in final closure review of deviation / non-conformance investigations, including analytical and batch disposition determination;---Solid experience working with CMOs, contract test laboratories and packaging / labeling.Technical Skills:Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe ProOther:---Exceptional organizational skills; written and verbal communication skills; and analytical and problem-solving skills;---Ability to work in a dynamic, fast-paced environment with shifting priorities;---Travel Requirements: Approximately 25% (both domestic and international)Veloxis Pharmaceuticals, Inc. is an Equal Opportunity / Affirmative Action employer, and will consider all qualified applicants for employment with regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.**Only submitted applications with a cover letter and current resume will be considered.

Keywords: Veloxis Pharmaceuticals, Inc., Raleigh , Director, Quality Control, Executive , Raleigh, North Carolina

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